Kangaroo mother care to reduce morbidity and mortality in low birthweight infants

  • Review
  • Intervention

Authors

  • Agustin Conde-Agudelo,

    Corresponding author
    1. Eunice Kennedy Shriver National Institute of Child Health and Human Development/National Institutes of Health/Department of Health and Human Services, Bethesda, MD and Detroit, MI, and Department of Obstetrics and Gynecology, Wayne State University, Perinatology Research Branch, Detroit, Michigan, USA
    • Agustin Conde-Agudelo, Perinatology Research Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development/National Institutes of Health/Department of Health and Human Services, Bethesda, MD and Detroit, MI, and Department of Obstetrics and Gynecology, Wayne State University, Detroit, Michigan, USA. condeagu@hotmail.com.

  • José L Díaz-Rossello

    1. Departamento de Neonatologia del Hospital de Clínicas, Montevideo, Uruguay

Abstract

Background

Kangaroo mother care (KMC), originally defined as skin-to-skin contact between a mother and her newborn, frequent and exclusive or nearly exclusive breastfeeding, and early discharge from hospital, has been proposed as an alternative to conventional neonatal care for low birthweight (LBW) infants.

Objectives

To determine whether evidence is available to support the use of KMC in LBW infants as an alternative to conventional neonatal care before or after the initial period of stabilization with conventional care, and to assess beneficial and adverse effects.

Search methods

We used the standard search strategy of the Cochrane Neonatal Review Group. This included searches in CENTRAL (Cochrane Central Register of Controlled Trials; 2016, Issue 6), MEDLINE, Embase, CINAHL (Cumulative Index to Nursing and Allied Health Literature), LILACS (Latin American and Caribbean Health Science Information database), and POPLINE (Population Information Online) databases (all from inception to June 30, 2016), as well as the WHO (World Health Organization) Trial Registration Data Set (up to June 30, 2016). In addition, we searched the web page of the Kangaroo Foundation, conference and symposia proceedings on KMC, and Google Scholar.

Selection criteria

Randomized controlled trials comparing KMC versus conventional neonatal care, or early-onset KMC versus late-onset KMC, in LBW infants.

Data collection and analysis

Data collection and analysis were performed according to the methods of the Cochrane Neonatal Review Group.

Main results

Twenty-one studies, including 3042 infants, fulfilled inclusion criteria. Nineteen studies evaluated KMC in LBW infants after stabilization, one evaluated KMC in LBW infants before stabilization, and one compared early-onset KMC with late-onset KMC in relatively stable LBW infants. Sixteen studies evaluated intermittent KMC, and five evaluated continuous KMC.

KMC versus conventional neonatal care: At discharge or 40 to 41 weeks' postmenstrual age, KMC was associated with a statistically significant reduction in the risk of mortality (risk ratio [RR] 0.60, 95% confidence interval [CI] 0.39 to 0.92; eight trials, 1736 infants), nosocomial infection/sepsis (RR 0.35, 95% CI 0.22 to 0.54; five trials, 1239 infants), and hypothermia (RR 0.28, 95% CI 0.16 to 0.49; nine trials, 989 infants; moderate-quality evidence). At latest follow-up, KMC was associated with a significantly decreased risk of mortality (RR 0.67, 95% CI 0.48 to 0.95; 12 trials, 2293 infants; moderate-quality evidence) and severe infection/sepsis (RR 0.50, 95% CI 0.36 to 0.69; eight trials, 1463 infants; moderate-quality evidence). Moreover, KMC was found to increase weight gain (mean difference [MD] 4.1 g/d, 95% CI 2.3 to 5.9; 11 trials, 1198 infants; moderate-quality evidence), length gain (MD 0.21 cm/week, 95% CI 0.03 to 0.38; three trials, 377 infants) and head circumference gain (MD 0.14 cm/week, 95% CI 0.06 to 0.22; four trials, 495 infants) at latest follow-up, exclusive breastfeeding at discharge or 40 to 41 weeks' postmenstrual age (RR 1.16, 95% CI 1.07 to 1.25; six studies, 1453 mothers) and at one to three months' follow-up (RR 1.20, 95% CI 1.01 to 1.43; five studies, 600 mothers), any (exclusive or partial) breastfeeding at discharge or at 40 to 41 weeks' postmenstrual age (RR 1.20, 95% CI 1.07 to 1.34; 10 studies, 1696 mothers; moderate-quality evidence) and at one to three months' follow-up (RR 1.17, 95% CI 1.05 to 1.31; nine studies, 1394 mothers; low-quality evidence), and some measures of mother-infant attachment and home environment. No statistically significant differences were found between KMC infants and controls in Griffith quotients for psychomotor development at 12 months’ corrected age (low-quality evidence). Sensitivity analysis suggested that inclusion of studies with high risk of bias did not affect the general direction of findings nor the size of the treatment effect for main outcomes.

Early-onset KMC versus late-onset KMC in relatively stable infants: One trial compared early-onset continuous KMC (within 24 hours post birth) versus late-onset continuous KMC (after 24 hours post birth) in 73 relatively stable LBW infants. Investigators reported no significant differences between the two study groups in mortality, morbidity, severe infection, hypothermia, breastfeeding, and nutritional indicators. Early-onset KMC was associated with a statistically significant reduction in length of hospital stay (MD 0.9 days, 95% CI 0.6 to 1.2).

Authors' conclusions

Evidence from this updated review supports the use of KMC in LBW infants as an alternative to conventional neonatal care, mainly in resource-limited settings. Further information is required concerning the effectiveness and safety of early-onset continuous KMC in unstabilized or relatively stabilized LBW infants, as well as long-term neurodevelopmental outcomes and costs of care.

Résumé scientifique

Les soins maternels kangourou pour réduire la morbidité et la mortalité chez les nourrissons de faible poids de naissance

Contexte

Les soins maternels kangourou (SMK), initialement définis comme un contact corporel entre la mère et son nouveau-né, un allaitement fréquent et exclusif ou quasi-exclusif, et une sortie précoce de l'hôpital ont été proposés en tant qu'alternative aux soins néonatals conventionnels chez les nourrissons de faible poids de naissance (FPN).

Objectifs

Déterminer si des données sont disponibles pour soutenir l'utilisation des SMK chez les nourrissons FPN en tant qu'alternative aux soins néonatals conventionnels avant ou après la première période de stabilisation avec des soins conventionnels, et d'évaluer les effets bénéfiques et néfastes.

Stratégie de recherche documentaire

Nous avons utilisé la stratégie de recherche standard du groupe de revue Cochrane sur la néonatologie. Cela inclut notamment des recherches dans les bases de données CENTRAL (registre Cochrane des essais contrôlés ; 2016, numéro 6), MEDLINE, Embase, CINAHL (Cumulative Index to Nursing and Allied Health Literature), LILACS (Latin American and Caribbean Health Science Information) et POPLINE (Population Information Online) [incluant toutes les bases de données depuis leur création jusqu'au 30 juin 2016], ainsi que l'ensemble des données de l’OMS pour l’enregistrement des essais cliniques (jusqu'au 30 juin 2016). En outre, nous avons effectué des recherches sur le site internet de la Kangaroo Foundation, les actes de conférences et de symposiums sur les SMK et Google Scholar.

Recueil et analyse des données

La collecte et l'analyse des données ont été effectuées selon les méthodes du groupe de revue Cochrane sur la néonatologie.

Résultats principaux

Vingt et une études portant sur 3042 nourrissons remplissaient les critères d'inclusion. Dix-neuf études évaluaient les SMK chez des nourrissons FPN après la stabilisation, une étude évaluait les SMK chez des nourrissons FPN avant la stabilisation, et une autre étude comparait les SMK à début précoce avec les SMK à début tardif chez des nourrissons FPN relativement stables. Seize études évaluaient des SMK intermittents et cinq évaluaient des SMK continus.

Les SMK versus les soins néonatals conventionnels : A la sortie d'hôpital ou entre 40 à 41 semaines d'âge post-menstruel, les SMK étaient associés à une réduction statistiquement significative du risque de mortalité (risque relatif [RR] 0,60, intervalle de confiance [IC] à 95 % de 0,39 à 0,92 ; huit essais, 1736 nourrissons), d'infections / sepsies nosocomiales (RR 0,35, IC à 95 % 0,22 à 0,54 ; cinq essais, 1239 nourrissons), et d'hypothermie (RR 0,28, IC à 95 % 0,16 à 0,49 ; neuf essais, 989 nourrissons ; preuves de qualité moyenne). Lors du dernier suivi, les SMK étaient associés à un risque réduit de façon significative de la mortalité (RR 0,67, IC à 95 % 0,48 à 0,95 ; 12 essais, 2293 nourrissons ; preuves de qualité moyenne) et des infections / sepsies sévères (RR 0,50, IC à 95 % 0,36 à 0,69 ; huit essais, 1463 nourrissons ; preuves de qualité moyenne). En outre, il a été découvert que les SMK augmentent la prise de poids (différence moyenne [DM] de 4,1 g / jour, IC à 95 % 2,3 à 5,9 ; 11 essais, 1198 nourrissons ; preuves de qualité moyenne), le gain de taille (DM 0,21 cm / semaine, IC à 95 % 0,03 à 0,38 ; trois essais, 377 nourrissons) et la prise de périmètre crânien (DM 0,14 cm / semaine, IC à 95 % 0,06 à 0,22 ; quatre essais, 495 nourrissons) lors du dernier suivi, l'allaitement exclusif à la sortie d'hôpital ou entre 40 et 41 semaines d'âge post-menstruel (RR 1,16, IC à 95 % 1,07 à 1,25 ; six études, 1453 mères) et lors du suivi entre un et trois mois (RR 1,20, IC à 95 % 1,01 à 1,43 ; cinq études, 600 mères), tout allaitement (exclusif ou partiel) à la sortie de l'hôpital ou au bout de 40 à 41 semaines d'âge post-menstruel (RR 1,20, IC à 95 % 1,07 à 1,34 ; 10 études, 1696 mères ; preuves de qualité moyenne) et lors du suivi entre un et trois mois (RR 1,17, IC à 95 % 1,05 à 1,31 ; neuf études, 1394 mères ; preuves de faible qualité), et certaines mesures de l'attachement mère-nourrisson et de l'environnement familial. Aucune différence statistiquement significative n'a été observée entre les nourrissons sous SMK et les témoins dans l'échelle de Griffiths pour le développement psychomoteur à 12 mois d'âge corrigé (preuves de faible qualité). L'analyse de sensibilité a suggéré que l'inclusion d'études à risque élevé de biais n'a pas affecté la direction générale des résultats, ni l'ampleur de l'effet du traitement pour les principaux critères de jugement.

Les SMK à début précoce versus les SMK à début tardif chez les nourrissons relativement stables : Un essai comparait des SMK continus à début précoce (dans les 24 heures suivant la naissance) par rapport à des SMK continus à début tardif (après 24 heures après la naissance) chez 73 nourrissons FPN relativement stables. Les chercheurs n'ont rapporté aucune différence significative entre les deux groupes d'étude concernant la mortalité, la morbidité, les infections graves, l'hypothermie, l'allaitement, et les indicateurs nutritionnels. Les SMK à début précoce étaient associés à une réduction statistiquement significative de la durée de séjour à l'hôpital (DM 0,9 jours, IC à 95 % 0,6 à 1,2).

Conclusions des auteurs

Les données issues de cette revue mise à jour sont favorables à l'utilisation des SMK chez les nourrissons FPN en tant qu'alternative aux soins néonatals conventionnels, principalement dans les environnements aux ressources limitées. Des informations supplémentaires sont nécessaires concernant l'efficacité et la sécurité des SMK à début précoce continus chez les nourrissons FPN relativement stabilisés ou non stabilisés, ainsi que sur les résultats du développement neurologique à long terme et les coûts des soins.

Resumo

Método canguru para redução da morbidade e da mortalidade de recém-nascidos de baixo peso

Introdução

O método canguru consiste no contato pele a pele entre a mãe e o recém-nascido (RN), amamentação frequente e exclusiva (ou quase exclusiva) e alta hospitalar precoce. Esse método tem sido proposto como uma alternativa ao cuidado neonatal convencional para os RNs de baixo peso.

Objetivos

Avaliar se as evidências apoiam o uso do método canguru em RNs de baixo peso como alternativa ao cuidado neonatal convencional, antes ou após um período inicial de estabilização clínica com cuidado neonatal convencional. Avaliar a efetividade e os eventos adversos desse método.

Métodos de busca

Usamos a estratégia de busca padronizada do grupo Cochrane Neonatal Review Group. Fizemos buscas nas seguintes bases de dados, desde seu início até 30 de junho 2016: CENTRAL (Cochrane Central Register of Controlled Trials; 2016, Issue 6), MEDLINE, Embase, CINAHL (Cumulative Index to Nursing and Allied Health Literature), LILACS (Latin American and Caribbean Health Science Information database) e POPLINE (Population Information Online). Também fizemos buscas na plataforma de registro de ensaios clínicos da Organização Mundial da Saúde (World Health Organization Trial Registration Data Set) em 30 de junho de 2016. Além disso, fizemos buscas na página da internet da Kangaroo Foundation, em anais de conferências e simpósios sobre o método canguru, e no Google Acadêmico.

Critério de seleção

Selecionamos ensaios clínicos randomizados (ECR) que comparam o método canguru versus o cuidado neonatal convencional ou com o método canguru de início precoce versus tardio, em RNs de baixo peso.

Coleta dos dados e análises

Fizemos a coleta e análise dos dados seguindo os métodos do Cochrane Neonatal Review Group.

Principais resultados

Um total de 21 estudos envolvendo 3.042 RNs preencheu os critérios de inclusão; 19 estudos avaliaram o método canguru em RNs de baixo peso após sua estabilização, 1 avaliou o método antes da estabilização e 1 estudo comparou o início precoce versus tardio do método em RNs de baixo peso relativamente estáveis. Dezesseis estudos avaliaram o método canguru usado de forma intermitente e cinco avaliaram a intervenção usada de forma contínua.

Método canguru versus cuidado neonatal convencional: nas avaliações feitas no momento da alta hospitalar ou quando o RN estava com 40 ou 41 semanas de idade pós-menstrual, o método canguru reduziu de forma significativa o risco de mortalidade (risco relativo [RR] 0,60, intervalo de confiança [IC] de 95%: 0,39 a 0,92; 8 ECRs, 1736 RNs), o risco de infecção nosocomial/sepse (RR 0.35, IC 95%: 0,22 a 0,54; 5 ECRs, 1239 RNs), e o risco de hipotermia (RR 0,28, IC 95% 0,16 a 0,49; 9 ECRs, 989 RNs; evidência de qualidade moderada). No último seguimento, o método canguru reduziu de forma significativa o risco de mortalidade (RR 0,67, IC 95% 0,48 a 0,95; 12 ECRs, 2293 RNs; evidência de qualidade moderada) e de infecção grave/sepse (RR 0,50, IC 95% 0,36 a 0,69; 8 ECRs, 1.463 RNs; evidência de qualidade moderada). Além disso, na última avaliação feita nos RNs, o método canguru aumentou o ganho de peso (diferença média [MD] 4,1 g/dia, IC 95% 2,3 a 5,9 g; 11 ECRs, 1.198 RNs; evidência de qualidade moderada), o ganho de altura (MD 0,21 cm/semana, IC 95% 0,03 a 0,38; 3 ECRs, 377 RNs) e da circunferência cefálica (MD 0,14 cm/semana, IC 95% 0,06 a 0,22; 4 ECRs, 495 RNs). O método canguru também aumentou a probabilidade de o RN estar em amamentação exclusiva na alta ou com 40-41 semanas de idade pós-menstrual (RR 1,16, IC 95% 1,07 a 1,25; 6 ECRs, 1453 mães) e no seguimento feito com 1 a 3 meses de vida (RR 1,20, IC 95% 1,01 a 1,43; 5 ECRs, 600 mães). O método canguru também aumentou a probabilidade de o RN estar sendo amamentado (de forma exclusiva ou parcial) na alta ou com 40 a 41 semanas de idade pós-menstrual (RR 1,20, IC 95% 1,07 a 1,34; 10 ECRs, 1.696 mães; evidência de qualidade moderada) e no seguimento feito com 1 a 3 meses de vida (RR 1,17, IC 95% 1,05 a 1,31; 9 ECRs, 1.394 mães; evidência de baixa qualidade), e ainda de aumentar os escores de algumas medidas de proximidade mãe-bebê e ambientais. Não houve diferença estatisticamente significativa entre os grupos (canguru e controle) quanto ao desenvolvimento psicomotor (avaliada pelo quociente Griffith) aos 12 meses de idade corrigida (evidência de baixa qualidade). As análises de sensibilidade sugerem que a inclusão dos estudos com alto risco de viés não afeta a direção geral dos resultados nem a estimativa do tamanho do efeito para os principais desfechos.

Método canguru de início precoce versus tardio em RNs relativamente estáveis: um ECR comparou o método canguru contínuo de início precoce (nas primeiras 24 horas após o nascimento) versus o método canguru contínuo de início tardio (depois de 24 horas do nascimento) em 73 RNs de baixo peso cujo estado clínico era relativamente estável. Os investigadores relataram que não houve diferença estatisticamente significante entre os grupos quanto à mortalidade, morbidade, infecção grave, hipotermia, amamentação e outros indicadores. O método canguru de início precoce reduziu de forma significativa a duração da internação hospitalar (MD 0,9 dias, IC 95% 0,6 a 1,2).

Conclusão dos autores

As evidências desta revisão atualizada apoiam o uso do método canguru para os RNs de baixo peso como uma alternativa ao cuidado neonatal convencional, especialmente nos locais com recursos limitados. São necessários mais estudos sobre a efetividade e segurança do método canguru contínuo de início precoce em RNs instáveis ou relativamente estáveis. Também são necessários mais estudos quanto aos efeitos do método sobre o desenvolvimento neurológico dos RNs no longo prazo e os custos para o sistema de saúde.

Plain language summary

Kangaroo mother care to reduce morbidity and mortality in low birthweight infants

Review question: Does kangaroo mother care (KMC) reduce morbidity and mortality in low birthweight (LBW) infants?

Background: Conventional neonatal care of LBW infants (< 2500 g) is expensive and requires both highly skilled personnel and permanent logistical support. KMC has been proposed as an alternative to conventional neonatal care of LBW infants. The major component of KMC is skin-to-skin contact between mother and newborn. The other two components of KMC are frequent and exclusive or nearly exclusive breastfeeding and attempted early discharge from hospital.

Study characteristics: We identified 21 randomized controlled trials (3042 infants) for inclusion in this review by searching medical databases in June 2016.

Key results: Compared with conventional neonatal care, KMC was found to reduce mortality at discharge or at 40 to 41 weeks' postmenstrual age and at latest follow-up, severe infection/sepsis, nosocomial infection/sepsis, hypothermia, severe illness, and lower respiratory tract disease. Moreover, KMC increased weight, length, and head circumference gain, breastfeeding at discharge or at 40 to 41 weeks' postmenstrual age and at one to three months' follow-up, mother satisfaction with method of infant care, some measures of maternal-infant attachment, and home environment. Researchers noted no differences in neurodevelopmental and neurosensory outcomes at 12 months' corrected age.

Quality of evidence: Most critical and important outcomes had moderate-quality evidence.

Conclusions: KMC is an effective and safe alternative to conventional neonatal care for LBW infants, mainly in resource-limited countries.

Résumé simplifié

Les soins maternels kangourou pour réduire la morbidité et la mortalité chez les nourrissons de faible poids de naissance

Question de la revue : est-ce que les soins maternels kangourou (SMK) réduisent la morbidité et la mortalité chez les nourrissons de faible poids de naissance (FPN) ?

Contexte : généralement, les soins néonatals des nourrissons FPN (< 2500 g) sont coûteux et requièrent du personnel hautement qualifié ainsi que des logistiques de soutien permanentes. Les SMK ont été proposés en tant qu'alternative aux soins néonatals conventionnels de nourrissons FPN. Le principal composant des SMK est le contact corporel entre la mère et le nouveau-né. Les deux autres composants des SMK sont l'allaitement fréquent et exclusif ou quasi-exclusif et la tentative de sortie précoce de l'hôpital.

Caractéristiques des études : nous avons identifié 21 essais contrôlés randomisés (3042 nourrissons) pour l'inclusion dans cette revue en effectuant des recherches dans les bases de données médicales en juin 2016.

Résultats principaux : par rapport aux soins néonatals conventionnels, les SMK ont permis de réduire la mortalité à la sortie de l'hôpital ou au bout de 40 à 41 semaines d'âge post-menstruel et lors du dernier suivi, les infections / sepsies sévères, les infections / sepsies nosocomiales, l'hypothermie - une maladie grave - et les maladies des voies respiratoires inférieures. En outre, les SMK augmentaient le poids, la taille, le gain de périmètre crânien, l'allaitement à la sortie d'hôpital ou au bout de 40 à 41 semaines d'âge post-menstruel et lors du suivi entre un et trois mois, la satisfaction de la mère envers les méthodes de soin du nourrisson, certaines mesures d'attachement materno-infantile et de l'environnement familial. Les chercheurs n'ont noté aucune différence en termes de résultats entre le développement neurologique et les neurosensoriels à 12 mois d'âge corrigé.

Qualité des preuves : la plupart des critères de jugement importants et critiques présentaient des preuves de qualité moyenne.

Conclusions : les SMK sont une alternative efficace et sûre aux soins néonatals conventionnels chez les nourrissons FPN, principalement dans les pays aux ressources limitées.

Notes de traduction

Post-édition : Pauline Leseurre (M2 ILTS, Université Paris Diderot)

Laički sažetak

Klokan metoda za smanjenje pobola i smrtnosti kod novorođenčadi s niskom porođajnom težinom

Istraživačko pitanje: Može li klokan metoda smanjiti pobol i smrtnost u djece vrlo niske porođajne težine?

Dosadašnje spoznaje: Konvencionalna metoda neonatalne skrbi djece s niskom porođajnom težinom (<2500 g) je skupa i zahtijeva visoko kvalificirano osoblje i stalnu logističku podršku. Klokan metoda je predložena kao drugi način pružanja skrbi djeci s vrlo niskom porođajnom težinom. Glavna komponenta klokan metode je kontakt koža-na-kožu između majke i njenog djeteta. Druge dvije komponente klokan metode su često i isključivo ili gotovo isključivo dojenje i nastojanje da se dijete što ranije otpusti iz bolnice.

Obilježja uključenih istraživanja: Za uključivanje u ovaj Cochrane sustavni pregled pronađen je 21 randomizirani klinički pokus (s ukupno 3042 djece). U sustavni pregled uključena su istraživanja objavljena do lipnja 2016.

Ključni rezultati U usporedbi sa standardnom skrbi klokan metoda smanjuje smrtnost do otpusta ili do 40. ili 41. tjedna dobi nakon zadnje menstruacije i na datum zadnjeg praćenja. Smanjuje i učestalost teške infekcije/sepse, nozokomijalnih infekcija/sepse, pothlađivanja (hipotermije), teške bolesti i upala donjeg dišnog sustava. Nadalje, klokan metoda poboljšava napredak u tjelesnoj težini, duljini i opsegu glave, dojenje pri otpustu ili do 40. ili 41. tjedna dobi nakon zadnje menstruacije ili nakon 1-3 mjeseca praćenja. Također poboljšava zadovoljstvo majke liječenjem djeteta, određene mjere povezanosti majke i djeteta te kućni okoliš. Istraživači nisu uočili razlike među djecom koja jesu i nisu primala klokan metodu u neuro-razvojnim i neuro-osjetnim rezultatima nakon 12 mjeseci korigirane dobi.

Kvaliteta dokaza Većina važnih rezultata ocijenjena je kao dokazi umjerene kvalitete.

Zaključak: Klokan metoda je djelotvoran i siguran drugi način pristupa u odnosu na standardnu skrb za nedonoščad i djecu s niskom porođajnom težinom, osobito u zemljama niskih prihoda.

Bilješke prijevoda

Cochrane Hrvatska
Prevele: Dalibora Behmen i Livia Puljak
Ovaj sažetak preveden je u okviru volonterskog projekta prevođenja Cochrane sažetaka. Uključite se u projekt i pomozite nam u prevođenju brojnih preostalih Cochrane sažetaka koji su još uvijek dostupni samo na engleskom jeziku. Kontakt: cochrane_croatia@mefst.hr

Ringkasan bahasa mudah

'Kangaroo mother care' atau jagaan ibu 'kangaroo' untuk mengurangkan morbiditi dan mortaliti dalam bayi kurang berat badan

Soalan kajian: Adakah Jagaan ibu "kangaroo" (KMC) mengurangkan morbiditi dan mortaliti bayi kurang berat badan?

Latar belakang: Penjagaan neonatal konvensional bagi bayi LBW (< 2500 g) adalah mahal dan memerlukan kakitangan berkemahiran tinggi serta sokongan logistik yang tetap. KMC telah dicadangkan sebagai alternatif kepada penjagaan neonatal konvensional untuk bayi LBW. Komponen utama KMC ialah sentuhan kulit-ke-kulit (SSC) diantara seorang ibu dan bayinya yang baru lahir. Dua komponen lain bagi KMC adalah kekerapan dan penyusuan ibu secara eksklusif atau hampir-hampir eksklusif serta cubaan untuk discaj awal dari hospital.

Ciri-ciri kajian: Kami telah mengenalpasti dua puluh satu kajian terkawal rawak (3042 bayi) untuk dimasukkan dalam ulasan ini melalui carian pangkalan data perubatan pada bulan Jun 2016.

Keputusan utama: Berbanding dengan penjagaan neonatal konvensional, KMC didapati mengurangkan kematian bayi pada masa discaj atau pada usia 40-41 minggu selepas haid serta pada lawatan susulan terkini. Selain daripada itu, KMC juga mengurangkan jangkitan kuman teruk/sepsis, jangkitan kuman nosokomial/sepsis, hipotermia, penyakit tenat, dan penyakit trek respiratori bawah. Tambahan, KMC menambahkan berat badan, panjang dan lilitan kepala, menyusu susu ibu sewaktu discaj atau pada umur 40 hingga 41 minggu selepas haid dan pada satu hingga tiga bulan susulan, kepuasan ibu dengan kaedah penjagaan bayi, ukuran pertalian ibu-bayi dan persekitaran rumah. Penyelidik-penyelidik mendapati tiada perbezaan dalam hasil perkembangan neuro dan sensori neuro pada usia 12 bulan (umur pembetulan).

Kualiti bukti: Kebanyakan hasil penting dan kritikal mempunyai bukti berkualiti sederhana.

Rumusan: KMC adalah penjagaan alternatif yang selamat dan berkesan berbanding penjagaan neonatal konvensional bagi bayi rendah berat badan, terutamanya di negara-negara dengan sumber terhad.

Catatan terjemahan

Diterjemahkan oleh Sook Lee Foo (Penang Medical College). Disunting oleh Lai Nai Ming, School of Medicine, Taylor's University, Malaysia.Untuk sebarang pertanyaan mengenai terjemahan ini sila hubungi fslee@pmc.edu.my

எளியமொழிச் சுருக்கம்

குறைந்த பிறப்பு எடை கொண்ட பச்சிளங் குழந்தைகளில் நோயுற்ற நிலை மற்றும் இறப்பைக் குறைப்பதற்கு காங்காரு தாய்மை பராமரிப்பு

திறனாய்வு கேள்விகுறைந்த பிறப்பு எடை கொண்ட பச்சிளங் குழந்தைகளில் நோயுற்ற நிலை மற்றும் இறப்பைக் குறைப்பதற்குக் காங்காரு தாய்மை பராமரிப்பு உதவுமா?

பின்புலம் குறைந்த பிறப்பு எடை கொண்ட பச்சிளங் குழந்தைகளில் (< 2500 g), பாரம்பரியமான பச்சிளங் குழந்தை பராமரிப்பு அதிக பணச்செலவு கொண்டதாகும். மேலும் அதிக செயல்திறன் கொண்ட ஊழியர்கள் மற்றும் நிரந்தரமான ஏற்பாட்டியல் ஆதரவு இரண்டும் தேவைப்படும். குறைந்த பிறப்பு எடை கொண்ட பச்சிளங்குழந்தைகளுக்கு வழக்கமான பராமரிப்புக்கு மாற்றாக காங்காரு தாய்மை பராமரிப்பு முன்மொழியப்பட்டது. ஒரு தாய்க்கும், அவளின் புதிதாய் பிறந்த குழந்தைக்கும் தோலோடு-தோல் தொடர்பு (ஸ்கின்-டு- ஸ்கின் கான்டாக்ட்) என்பது கேஎம்சி-யின் ஒரு முக்கியமான கூறாகும். அடிக்கடியான மற்றும் பிரத்யேக அல்லது ஓரளவு பிரத்யேக தாய் பாலூட்டல் மற்றும் மருத்துவமனையிலிருந்து விரைவாக வெளியேறுவதற்கு முயற்சி செய்வது கேஎம்சியின் பிற இரண்டு கூறுகளாகும்.

ஆய்வு பண்புகள்2016 ஜூன் வரையிலான மருத்துவ தரவுத் தளங்களைத் தேடி 21 சமவாய்ப்பு கட்டுப்பாட்டு சோதனைகளை(3042 கைக்குழந்தைகள் கொண்டவை ) இந்த திறனாய்வுக்குச் சேர்த்தோம்.

முக்கிய முடிவுகள்பாரம்பரியமான பச்சிளங் குழந்தை பராமரிப்பை ஒப்பிடுகையில், காங்காரு தாய்மை பராமரிப்பு மருத்துவமனையிலிருந்து வெளியேறலின் போது, அல்லது மாதவிடாய் பின்னான 40-41 வாரங்களில் இறப்பைக் குறைத்தது. மற்றும் மிக சபீபத்திய பின்-தொடரலின் போது,கடுமையான தொற்று/ சீழ் பிடித்தல், மருத்துவமனை தொற்று/ சீழ் பிடித்தல்,ஹைபோதெர்மியா, கடுமையான உடல்நலக் குறைவு, கீழ் பகுதி மூச்சு தட வியாதி, மற்றும் மருத்துவமனை தங்கலின் கால நீளத்தை குறைக்கிறது என கண்டறியப்பட்டது. எல்லாவற்றிற்கும் மேலாக, எடை, தலை சுற்றளவு, மற்றும் நீள அதிகரிப்பு,தாய் பாலுட்டல், பச்சிளங் குழந்தையில் பராமரிப்பு முறையில் தாயின் திருப்தி,தாய்- சேய் ஒட்டுதலின் சில அளவீடுகள் மற்றும் வீட்டு சூழல் ஆகியவற்றையும் கேஎம்சி அதிகரித்தது. சரி செய்யப்பட்ட ஒரு வருட வயதில், நரம்பியல்வளர்ச்சி மற்றும் நரம்பியல்தொடுவுணர்வு விளைவுகளில் எந்த வித்தியாசங்களும் இருக்கவில்லை.

ஆதாரத்தின் தரம் மிக முக்கியமான விளைவுபயன்கள் மிதமான-தரம் கொண்ட ஆதாரமாக இருந்தன.

முடிவுரைகுறிப்பாக, வளக்-குறைவான நாடுகளில், குறைந்த பிறப்பு எடை கொண்ட பச்சிளங் குழந்தைகளில் பாரம்பரியமான பச்சிளங்குழந்தை பராமரிப்பிற்கு ஒரு திறன்மிக்க மற்றும் பாதுக்காப்பான மாற்றாக காங்காரு தாய்மை பராமரிப்பு (காங்காரு மதர் கேர், கேஎம்சி) இருக்கிறது.

மொழிபெயர்ப்பு குறிப்புகள்

மொழிபெயர்ப்பு: சி.இ.பி.என்.அர் குழு

Streszczenie prostym językiem

Kangurowanie w celu zmniejszenia chorobowości i umieralności u noworodków o niskiej masie urodzeniowej

Pytanie badawcze: Czy kangurowanie (kontakt „skóra do skóry” rodzica i dziecka) zmniejsza chorobowość i umieralność niemowląt o niskiej masie urodzeniowej?

Wprowadzenie: Tradycyjna opieka neonatologiczna nad niemowlętami z niską masą urodzeniową (<2500 g) jest kosztowna i wymaga zarówno wysoko wykwalifikowanego personelu jak i stałego wsparcia organizacyjnego. Kangurowanie jest alternatywną propozycją do tradycyjnej opieki neonatologicznej niemowląt z niską masą urodzeniową. Podstawą kangurowania jest kontakt skóra do skóry między matką a noworodkiem. Dwa inne czynniki kangurowania to częste i wyłączne lub prawie wyłączne karmienie piersią oraz staranie się o wczesny wypis ze szpitala.

Charakterystyka badań: Przeszukano bazy medyczne do czerwca 2016 roku i zidentyfikowano 21 badań z randomizacją (3042 niemowląt), spełniających kryteria włączenia do przeglądu.

Kluczowe wyniki: Kangurowanie w porównaniu do tradycyjnej opieki neonatologicznej zmniejsza umieralność niemowląt (w chwili wypisu ze szpitala, w wieku równym 40-41 tygodni od ostatniej miesiączki matki oraz w późniejszym okresie obserwacji), a także zmniejsza występowanie ciężkich infekcji/posocznicy (przyp. tłum. sepsy), zakażeń szpitalnych/posocznicy, hipotermii, chorób dolnych dróg oddechowych oraz innych ciężkich schorzeń. Co więcej, kangurowanie zwiększa przyrost masy ciała, długości ciała oraz obwodu główki dziecka, częstość karmienia piersią (w chwili wypisu ze szpitala, w wieku równym 40-41 tygodni od ostatniej miesiączki matki oraz oraz między pierwszym a trzecim miesiącem obserwacji), zadowolenie matki z metody opieki nad dzieckiem, oraz poprawia więź między matką a dzieckiem oraz środowiskiem domowym. Badacze nie zaobserwowali różnic w zakresie rozwoju neurologicznego oraz wyników neurosensorycznych w wieku 12 miesięcy skorygowanych (u dzieci urodzonych przedwcześnie koryguje się wiek poprzez odejmowanie od wieku urodzeniowego liczby tygodni o które rozwiązanie nastapiło wcześniej).

Jakość danych naukowych: Większość najważniejszych wyników opierała się na danych naukowych o umiarkowanej jakości.

Wyniki: Kangurowanie to skuteczna i bezpieczna alternatywa do tradycyjnej opieki neonatologicznej dla dzieci z niską masą urodzeniową, głównie w krajach o ograniczonych zasobach.

Uwagi do tłumaczenia

Tłumaczenie Magdalena Koperny Redakcja Paulina Rolska

Laienverständliche Zusammenfassung

Känguru-Methode zur Reduktion von Morbidität und Sterblichkeit in Kleinkindern mit niedrigem Geburtsgewicht

Fragestellung: Kann die Känguru-Methode (engl. kangaroo mother care, KMC) die Morbidität und Sterblichkeit in Kleinkindern mit niedrigem Geburtsgewicht (low birthweight, LBW) reduzieren?

Hintergrund. Konventionelle Neugeborenenversorgung von Kleinkindern mit niedrigem Geburtsgewicht (<2500g) ist teuer und benötigt sowohl hochqualifiziertes Fachpersonal und dauerhafte logistische Unterstützung. Die Kanguru-Methode wurde als eine Alternative zur konventionellen Neugeborenenversorgung von Kleinkindern mit niedrigem Geburtsgewicht empfohlen. Der wesentliche Bestandteil der Känguru-Methode ist der Haut-zu-Haut-Kontakt zwischen Mutter und ihrem Neugeborenen. Die anderen beiden Bestandteile sind regelmäßiges und ausschließliches oder fast ausschließliches Stillen und der Versuch der frühen Entlassung aus dem Krankenhaus.

Studienmerkmale: Durch die Literatursuche in medizinischen Datenbanken bis Juni 2016 identifizierten wir 21 randomisierte kontrollierte Studien (3042 Kleinkinder), die wir in diesen Review einschließen konnten.

Hauptergebnisse: Verglichen mit der konventionellen Neugeborenenversorgung wurde durch die Känguru-Methode eine Reduktion in der Sterblichkeit (bei der Geburt oder in der 40. bis 41. Woche nach Gestationsalter und zum letzten Zeitpunkt der Nachbeobachtung), von schweren Infektionen/Blutvergiftungen, von nosokomialen Infektion/Blutvergiftungen, von Hypothermien, von schweren Erkrankungen und von unteren Atemwegserkrankungen gefunden. Zudem steigerte KMC die Zunahme des Gewichts, der Größe und des Kopfumfangs des Kindes, das Stillen bei Entlassung, in der 40. bis 41. Woche nach Gestationsalter und nach ein bis drei Monaten Nachbeobachtungszeitraum, die Zufriedenheit der Mutter mit der Methode der Kinderversorgung, einige Maßzahlen der Mutter-Kind-Bindung und die häusliche Umwelt. Forscher fanden keine Unterschiede in neurosensorischen Endpunkten und in Endpunkten zur Entwicklung des Nervensystems nach 12 Monaten bereinigtes Alter.

Qualität der Evidenz: Die meisten kritischen und wichtigen Endpunkte hatten eine moderate Qualität der Evidenz.

Schlussfolgerung: Die Känguru-Methode ist eine wirksame und ungefährliche Alternative zur konventionellen neonatalen Versorgung von Kleinkindern mit niedrigem Gebutsgewicht, vor allem in Ländern mit eingeschränkten Ressourcen.

Anmerkungen zur Übersetzung

I. Nolle, freigegeben durch Cochrane Deutschland.

Резюме на простом языке

Метод "Кенгуру" для снижения заболеваемости и смертности среди детей с низким весом при рождении

Вопрос обзора: Снижает ли осуществление ухода методом "Кенгуру"заболеваемость и смертность среди младенцев с низким весом (массой тела) при рождении (НМТ)?

Актуальность: Обычный уход за маловесными новорожденными детьми (вес которых составляет менее 2500 г) является дорогостоящим и требует как высокой квалификации медицинского персонала, так и постоянной технической поддержки. Метод "Кенгуру" был предложен как альтернатива традиционному уходу за маловесными новорожденными детьми. Основным компонентом метода "Кенгуру"является контакт "кожа к коже" между матерью и новорожденным. Другие два наиболее частых компонента "Кенгуру" это исключительное или почти исключительное грудное вскармливание и попытка ранней выписки из больницы.

Характеристики исследований: Мы обнаружили двадцать одно рандомизированное контролируемое клиническое испытание (3042 младенца) для включения в этот обзор в результате поиска в медицинских базах данных в июне 2016 года.

Основные результаты: Было обнаружено, что по сравнению с традиционным оказанием помощи новорожденным, метод "Кенгуру" сокращает смертность к моменту выписки или на сроке 40-41 недели постконцептуального возраста и при последующем наблюдении, число случаев тяжелой инфекции/сепсиса, внутрибольничной инфекции/сепсиса, гипотермии, тяжелых заболеваний и заболеваний нижних дыхательных путей. Более того, метод "Кенгуру"приводил к большим прибавкам в весе, увеличению роста и окружности головы, повышению частоты грудного вскармливания к моменту выписки или на сроке 40 - 41 недели постконцептуального возраста и на протяжении от одного до трех месяцев наблюдения, большей удовлетворенности матери методом ухода за ребенком, некоторыми показателями привязанности матери и ребенка и домашней обстановкой. Исследователи не отметили различий в исходах, касающихся психомоторного и нейросенсорного развития в 12 месяцев скорректированного возраста.

Качество доказательств: Качество доказательств в отношении большинства существенных и важных исходов было умеренным.

Выводы: Метод "Кенгуру" является эффективной и безопасной альтернативой традиционному уходу за маловесными младенцами в периоде новорожденности, в основном, в странах с ограниченными ресурсами.

Заметки по переводу

Перевод: Саляхутдинова Алина Рустемовна. Редактирование: Камалова Аэлита Асхатовна, Юдина Екатерина Викторовна. Координация проекта по переводу на русский язык: Cochrane Russia - Кокрейн Россия (филиал Северного Кокрейновского Центра на базе Казанского федерального университета). По вопросам, связанным с этим переводом, пожалуйста, обращайтесь к нам по адресу: cochrane.russia.kpfu@gmail.com; cochranerussia@kpfu.ru

Resumo para leigos

Método canguru para diminuir a morbidade e a mortalidade de bebês de baixo peso

Pergunta da revisão: O método canguru reduz a mortalidade e a morbidade dos bebês de baixo peso?

Introdução: O cuidado neonatal habitual para os recém- nascidos (RN) de baixo peso (aqueles que nascem com menos de 2.500 gramas) é caro e exige uma equipe de profissionais altamente capacitados e um suporte logístico permanente. O método canguru foi proposto como uma alternativa ao cuidado neonatal convencional para os RNs de baixo peso. O principal componente do método canguru é o contato pele a pele entre o bebê e a mãe. Os outros dois componentes são a amamentação materna exclusiva ou predominante e a alta hospitalar precoce.

Características do estudo: Fizemos buscas nas bases de dados em junho de 2016 e encontramos 21 estudos clínicos randomizados (com 3.042 recém-nascidos) que puderam ser incluídos nesta revisão.

Principais resultados: Quando comparado com o cuidado neonatal convencional, o método canguru diminuiu o risco de mortalidade na alta do bebê ou quando o bebê estava com 40-41 semanas de idade (contada a partir da última menstruação antes do nascimento) ou na última avaliação feita. Além disso, o método canguru também diminui o risco de o bebê ter infecção grave/sepse, infecção nosocomial/sepse, hipotermia, doença grave ameaçadora à vida e doenças do trato respiratório inferior. O método canguru também aumentou a taxa de aleitamento materno e o ganho de peso, de altura e do tamanho da cabeça (perímetro cefálico) do RN na alta ou quando ele estava com 40 a 41 semanas de idade a partir da última menstruação ou com um a três meses de vida. O método também aumentou a satisfação materna com o cuidado do recém-nascido e melhorou algumas medidas do vínculo mãe-bebê e do ambiente familiar. Não houve diferenças no desenvolvimento neurológico e neuro-sensorial dos bebês aos 12 meses de vida (idade corrigida para os bebês prematuros).

Qualidade da evidência: A qualidade das evidências para os desfechos mais importantes foi moderada.

Conclusões: O método canguru é uma alternativa efetiva e segura ao cuidado neonatal convencional para os RNs de baixo peso, especialmente nos países com poucos recursos.

Notas de tradução

Traduzido pelo Cochrane Brazil (Vinícius Lopes Braga). Contato: tradutores@centrocochranedobrasil.org.br

Summary of findings(Explanation)

Summary of findings for the main comparison. Kangaroo mother care versus conventional neonatal care for reducing morbidity and mortality in low birthweight infants
  1. aMost of the pooled effect provided by studies with moderate or high risk of bias
    bSubstantial heterogeneity (I2 = 52%)
    cSubstantial heterogeneity (I2 = 86%)
    dSubstantial heterogeneity (I2 = 80%)
    eSubstantial heterogeneity (I2 = 62%)
    fEffect provided by 1 study with moderate risk of bias
    gWide 95% CI

Kangaroo mother care versus conventional neonatal care for reducing morbidity and mortality in low birthweight infants
Patient or population: infants with low birthweight
Settings: neonatal intensive care unit/newborn nursery/home
Intervention: kangaroo mother care
Comparison: conventional neonatal care
OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
Number of participants
(studies)
Quality of the evidence
(GRADE)
Comments
Assumed riskCorresponding risk
Conventional neonatal care Kangaroo mother care
Mortality at latest follow-up Study population RR 0.67
(0.48 to 0.95)
2293
(12 studies)
⊕⊕⊕⊝
moderate a
 
60 per 1000 40 per 1000
(29 to 57)
Moderate
30 per 1000 20 per 1000
(14 to 28)
Severe infection/sepsis at latest follow-up - stabilized infants Study population RR 0.5
(0.36 to 0.69)
1463
(8 studies)
⊕⊕⊕⊝
moderate a
 
131 per 1000 65 per 1000
(47 to 90)
Moderate
162 per 1000 81 per 1000
(58 to 112)
Hypothermia at discharge or at 40 to 41 weeks’ postmenstrual age - stabilized infants Study population RR 0.28
(0.16 to 0.49)
989
(9 studies)
⊕⊕⊕⊝
moderate b
 
271 per 1000 76 per 1000
(43 to 133)
Moderate
333 per 1000 93 per 1000
(53 to 163)
Weight gain at latest follow-up (g/d) - stabilized infants Mean weight gain at latest follow-up (g/d) - stabilized infants in the intervention groups - was
4.08 higher
(2.3 to 5.86 higher)
 1198
(11 studies)
⊕⊕⊕⊝
moderate c
 
Any breastfeeding at discharge or at 40 to 41 weeks' postmenstrual age - stabilized infants Study population RR 1.2
(1.07 to 1.34)
1696
(10 studies)
⊕⊕⊕⊝
moderate d
 
762 per 1000 914 per 1000
(815 to 1000)
Moderate
743 per 1000 892 per 1000
(795 to 996)
Any breastfeeding at 1 to 3 months' follow-up - stabilized infants Study population RR 1.17
(1.05 to 1.31)
1394
(9 studies)
⊕⊕⊝⊝
low a,e
 
711 per 1000 832 per 1000
(747 to 932)
Moderate
622 per 1000 728 per 1000
(653 to 815)
Griffith quotient for psychomotor development (all subscales) at 12 months' corrected age (copy) Mean Griffith quotient for psychomotor development (all subscales) at 12 months' corrected age (copy) in the intervention groups was
1.05 higher
(0.75 lower to 2.85 higher)
 579
(1 study)
⊕⊕⊝⊝
low f,g
 
*The basis for the assumed risk (eg, median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI)
CI = confidence interval; RR = risk ratio
GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate
Very low quality: We are very uncertain about the estimate

Background

Description of the condition

Low birthweight (LBW), defined as weight at birth of less than 2500 g, irrespective of gestational age, has an adverse effect on child survival and development, and may even be an important risk factor for adult disease (Barker 1995). Overall, it is estimated that 15% to 20% of all births worldwide are LBW, representing more than 20 million births a year, the great majority of them reported in low- and middle-income countries (WHO 2014). LBW is a major contributor to both neonatal and child mortality (Lawn 2014; UNICEF 2015). A complex process of care named conventional or modern neonatal care includes interventions already proven to lower the burden of neonatal morbidity and mortality. Conventional neonatal care of LBW infants is expensive and requires both trained personnel and permanent logistical support. This complexity is critical, mainly during the stabilization period, until the infant has adapted to autonomous extrauterine life. In low- and middle-income countries, financial and human resources for neonatal care are limited, and hospital wards for LBW infants are often overcrowded. Thus, interventions for LBW infants that reduce neonatal morbidity and mortality and costs would signify an important advance in care.

Description of the intervention

In 1978, Edgar Rey (Rey 1983) proposed and developed kangaroo mother care (KMC) at Instituto Materno Infantil in Santa Fe de Bogotá, Colombia, as an alternative to the conventional contemporary method of care for LBW infants. KMC was initially conceived to address the lack of incubators, the high rate of nosocomial infection, and the occurrence of infant abandonment at the local hospital. The term KMC is derived from similarities to marsupial caregiving. Mothers are used as "incubators" to maintain infants' body temperature, and as the main source of food and stimulation for LBW infants, while they mature enough to face extrauterine life in similar conditions as those born at term. Initially, the method was applied only after the LBW infant had stabilized, because LBW infants need a variable period of conventional care before they are eligible for KMC. Stabilization of respiratory, thermal, and feeding functions has been considered crucial for the success of this intervention. The definition of stabilization is not precise; stabilization has been defined as independent of gestational age and weight, which are the main variables associated with those vital functions. Some recent studies have evaluated the effectiveness of early-onset KMC (as soon as possible after birth) for LBW infants born in hospitals with little neonatal intensive care capacity (Nagai 2010; Worku 2005). Currently, the definition of KMC is characterized by significant heterogeneity (Chan 2016). The major component of KMC is skin-to-skin contact (SSC), by which infants are placed vertically between the mother's breasts firmly attached to the chest and below her clothes. SSC is offered to infants as far as the mother-infant dyad can tolerate it. Mothers can share the role of provider of SSC with others, especially the babies' fathers. The aim is to empower the mother (parents or caregivers) by gradually transferring the skills and responsibility for becoming the child's primary caregiver and meeting every physical and emotional need (Nyqvist 2010). The other two components of KMC are frequent and exclusive or nearly exclusive breastfeeding and attempts at early discharge from hospital, regardless of weight or gestational age, with strict follow-up. However, the last two components are less frequently identified as part of KMC (Chan 2016).

Different modalities of KMC have been adopted around the world (Charpak 1996), according to the needs of various settings. This diversity includes exclusive and non-exclusive breastfeeding, breast or gavage feedings, completely or partially naked, continuous (≥ 20 hours per day) or intermittent (for short periods once or a few times per day and for a variable number of days) SSC with variable duration of exposure, and early-or-not hospital discharge.

KMC has been reported to be associated with similar neonatal mortality after stabilization, some reduction of neonatal morbidity, greater quality of mother-to-child bonding, and shorter hospital stay and lower costs compared with standard, conventional care of LBW infants. Some researchers have claimed that KMC is the best option if neonatal care units are unavailable; if they are available but are overwhelmed by demand, KMC would allow rationalization of resources by freeing up incubators for sicker infants (Ruiz-Peláez 2004).

This review covered all randomized controlled trials (RCTs) of KMC with all its components, irrespective of duration of intervention, breastfeeding patterns, and time to discharge from hospital. We performed subgroup analyses for the primary outcome of mortality at discharge or at 40 to 41 weeks' postmenstrual age and at latest follow-up according to type of KMC (intermittent vs continuous), infant age at initiation of KMC (≤ 10 days vs >10 days), setting in which the trial was conducted (low/middle-income countries vs high-income countries), and infant stabilization (before vs after). For all outcomes in stabilized LBW infants, we performed subgroup analyses according to type of KMC (intermittent vs continuous). In addition, we included RCTs that compared early-onset (starting within 24 hours after birth) versus late-onset (starting after 24 hours after birth) KMC.

How the intervention might work

The intervention assumes that the mother maintains the infant's body temperature and is the main source of nutrition and stimulation, which are the main components of conventional neonatal care (Rey 1983). SSC would allow that an infant´s demands for care may trigger neuropsychobiological paths that increase maternal behavior and immediate response to infant needs, as well as increased lactogenesis (Diaz-Rossello 2008). In addition, KMC would empower the mother (parents or caregivers) by gradually transferring the skills and responsibility for becoming the child’s primary caregiver and meeting every physical and emotional need (Nyqvist 2010).

Why it is important to do this review

We undertook this systematic review to determine whether KMC reduces morbidity and mortality in LBW infants. We believe that this review provides a valuable resource for clinicians and policy makers in summarizing current best evidence and highlighting gaps in research.

Objectives

To determine whether evidence is available to support the use of KMC in LBW infants as an alternative to conventional neonatal care before or after the initial period of stabilization with conventional care, and to assess beneficial and adverse effects.

Methods

Criteria for considering studies for this review

Types of studies

Randomized controlled trials, including cluster-randomized trials, in which KMC (continuous or intermittent) was compared with conventional neonatal care in stabilized or non-stabilized LBW infants. Moreover, we included randomized trials that compared early-onset KMC versus late-onset KMC. We excluded trials if they were quasi-randomized, or if they evaluated effects of KMC in healthy full-term infants or in those with birthweight ≥ 2500 g, which is the topic of a separate review (Moore 2012), or if they used a cross-over design, or if they reported only results for physiological parameters, or if they evaluated only the effect of KMC on procedural pain in infants, which is the topic of a separate review (Johnston 2014), or if they assessed the effect of KMC on infant colic or on neonatal transport. In addition, we did not include studies in which KMC was part of a package of interventions for newborn care.

When trials were reported in abstracts, we planned to include them, provided information on study methods was sufficient to allow us to assess eligibility and risk of bias. If insufficient information was reported, we attempted to contact trial authors to request further information before deciding to exclude any study.

Types of participants

LBW Infants (defined as birthweight < 2500 g), regardless of gestational age.

Types of interventions

  • Comparisons of KMC with conventional neonatal care in LBW infants, regardless of infant stabilization status, duration of intervention, and breastfeeding patterns, and irrespective of whether or not discharge from hospital was early.

  • Comparisons of early-onset KMC with late-onset KMC in LBW infants, irrespective of infant stabilization status.

Types of outcome measures

We chose primary outcomes to be most representative of the clinically important measures of effectiveness and safety for these infants. Secondary outcomes included other clinical measures of effectiveness, mother-infant attachment or interaction, satisfaction with care, home environment and father involvement, and costs of care.

Primary outcomes
  • Mortality.

    • At discharge or at 40 to 41 weeks' postmenstrual age (from randomization until discharge or 40 to 41 weeks' postmenstrual age).

    • At six months of age or at six months' follow-up (from randomization until six months of age or six months' follow-up).

    • At 12 months' corrected age (from randomization until 12 months' corrected age).

    • At latest follow-up (from randomization until last follow-up).

  • Severe infection/sepsis (as defined in individual studies).

  • Severe illness (as defined in individual studies).

  • Infant growth.

    • Weight at discharge or at 40 to 41 weeks' postmenstrual age, and at six and 12 months' corrected age.

    • Weight gain at latest follow-up.

    • Length at discharge or at 40 to 41 weeks' postmenstrual age, and at six and 12 months' corrected age.

    • Length gain at latest follow-up.

    • Head circumference at discharge or at 40 to 41 weeks' postmenstrual age, and at six and 12 months' corrected age.

    • Head circumference gain at latest follow-up.

  • Neurodevelopmental and neurosensory impairment.

    • Psychomotor development (measured by a validated tool/instrument).

    • Cerebral palsy.

    • Deafness.

    • Visual impairment.

Secondary outcomes
  • Nosocomial infection/sepsis (as defined in individual studies).

  • Mild/moderate infection or illness (as defined in individual studies).

  • Lower respiratory tract disease (as defined in individual studies).

  • Diarrhea (as defined in individual studies).

  • Hypothermia (as defined in individual studies).

  • Hyperthermia (as defined in individual studies).

  • Length of hospital stay.

  • Re-admission to hospital.

  • Breastfeeding.

    • Exclusive breastfeeding at discharge or at 40 to 41 weeks' postmenstrual age, and at one to three and at six to 12 months' follow-up.

    • Any breastfeeding at discharge or at 40 to 41 weeks' postmenstrual age, and at one to two, three, six, and 12 months' follow-up.

    • Onset of breastfeeding.

  • Mother-infant attachment (measured by a validated tool/instrument).

  • Mother-infant interaction (measured by a validated tool/instrument).

  • Parental and familial satisfaction (measured by interviews).

  • Home environment and father involvement (measured by a validated tool/instrument).

  • Costs of care.

Search methods for identification of studies

Electronic searches

Appendix 1 shows the search strategy for the 2014 update. For the 2016 update, we used criteria and standard methods of The Cochrane Collaboration and the Cochrane Neonatal Review Group (see the Cochrane Neonatal Group search strategy for specialized register). This included searches of the CENTRAL (Cochrane Central Register of Controlled Trials; 2016, Issue 6) in The Cochrane Library; and MEDLINE via PubMed, Embase, LILACS (Latin American Caribbean Health Sciences Literature), POPLINE (Population Information Online), and CINAHL (Cumulative Index to Nursing and Allied Health Literature) databases (all from inception to June 30, 2016) using the following search terms: (Kangaroo OR skin-to-skin OR [skin to skin]), plus database-specific limiters for RCTs and neonates (see Appendix 2 for the full search strategies for each database). We applied no language restrictions.

We searched clinical trials registries for ongoing or recently completed trials (clinicaltrials.gov), the World Health Organization International Trials Registry and Platform (www.whoint/ictrp/search/en/), and the ISRCTN Registry (International Standard Randomized Controlled Trial Number Registry).

Searching other resources

We also searched the Web page of the Kangaroo Foundation, the International Network of Kangaroo Care, conference and symposia proceedings on KMC, reference lists of identified studies, textbooks, review articles, and Google Scholar. In addition, we performed journal handsearching and contacted investigators involved in the field to locate unpublished studies.

Data collection and analysis

Selection of studies

We used standard methods of The Cochrane Collaboration and its Neonatal Review Group. Two review authors retrieved and reviewed independently all studies deemed suitable to determine inclusion. We resolved disagreements through consensus.

Data extraction and management

Two review authors independently extracted data in duplicate from all reports and recorded them on a piloted form. We performed no blinding of authorship. We extracted the following data for each trial: authors; year of publication; country; level of care; human resources used; inclusion and exclusion criteria; study characteristics; mean or median weight and gestational age at birth, and infant age at enrollment by group; description of interventions; co-interventions; mean or median duration of KMC; criteria for infant discharge from the hospital; scheme for follow-up of infants after discharge; numbers randomized and analyzed; numbers of and reasons for withdrawal; and outcomes. Review authors resolved differences in data extracted by discussion and reached consensus. We sought additional information from individual investigators when published information did not include the required details. One review author (AC-A) entered data into Review Manager software (RevMan 2014), and the other review author (JLD-R) checked data for accuracy. We processed included trial data as described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011).     

Assessment of risk of bias in included studies

Two review authors who were not associated with any of the trials assessed risk of bias individually in each included trial. Review authors were not blind to author, institution, journal of publication, or results when conducting methodological assessments, as they were familiar with most of the studies. When differences in assessment of risk of bias arose, we reached a consensus. We assessed risk of bias by using the dimensions outlined in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). We assessed seven domains related to risk of bias in each included trial because evidence suggests that these are associated with biased estimates of treatment effect: random sequence generation, allocation concealment, blinding of participants and personnel, blinding of outcome assessment, incomplete outcome data, selective reporting, and other bias. We made a judgment about risk of bias for each of the seven domains as "low risk," "high risk," or "unclear risk."

Random sequence generation

"Low risk" of bias: Investigators described a random component in the sequence generation process such as random number table, computer random number generator, shuffling of cards or envelopes, drawing of lots, or computerized minimization.

"High risk" of bias: Investigators described a non-random component in the sequence generation process, such as odd or even date of birth, based on date or day of admission, based on hospital or clinical record number, or allocated by judgment of the clinician; preference of the participant; availability of the intervention; or results of laboratory tests.

"Unclear risk" of bias: information insufficient to permit judgment of "low risk" or "high risk."

Allocation concealment

"Low risk" of bias: Investigators used an adequate method to conceal allocation, such as central allocation (including telephone or web-based randomization) or sequentially numbered, opaque, sealed envelopes.

"High risk" of bias: Investigators used a non-adequate method to conceal allocation, such as open random allocation schedule (eg, a list of random numbers), assignment envelopes without appropriate safeguards, alternation or rotation, date of birth, or case record number.

"Unclear risk" of bias: information insufficient to permit judgment of "low risk" or "high risk."

Blinding of participants and personnel

"Low risk" of bias: As KMC cannot be implemented when masked, we considered adequate blinding of participants and personnel as either of the following: (1) no blinding or incomplete blinding, but review authors judged that the outcome was not likely to be influenced by lack of blinding; or (2) blinding of participants and key study personnel ensured, and unlikely that blinding could have been broken.

"High risk" of bias: either of the following: (1) no blinding or incomplete blinding, and the outcome was likely to be influenced by lack of blinding; or (2) blinding of key study participants and personnel attempted, but likely that blinding could have been broken, and the outcome was likely to be influenced by lack of blinding.

"Unclear risk" of bias: information insufficient to permit judgment of "low risk" or "high risk."

We assessed blinding of participants and personnel separately for each outcome or each class of outcomes (objective and subjective).

Blinding of outcome assessment

"Low risk" of bias: We considered blinding of outcome assessment to be adequate in either of the following: (1) no blinding of outcome assessment, but review authors judged that outcome measurement was not likely to be influenced by lack of blinding; or (2) blinding of outcome assessment ensured, and unlikely that blinding could have been broken.

"High risk" of bias: either of the following: (1) no blinding of outcome assessment, and outcome measurement was likely to be influenced by lack of blinding; or (2) blinding of outcome assessment, but likely that blinding could have been broken, and that outcome measurement was likely to be influenced by lack of blinding.

"Unclear risk" of bias: information insufficient to permit judgment of "low risk" or "high risk."

We assessed blinding of outcome assessment separately for each outcome or each class of outcomes (objective and subjective).

Incomplete outcome data

"Low risk" of bias: any one of the following: (1) no missing outcome data; (2) reasons for missing outcome data unlikely to be related to true outcome; (3) missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups; (4) for dichotomous outcome data, proportion of missing outcomes compared with observed event risk not enough to have a clinically relevant impact on the intervention effect estimate; (5) for continuous outcome data, plausible effect size among missing outcomes not enough to have a clinically relevant impact on observed effect size; or (6) missing data imputed by appropriate methods.

"High risk" of bias: any one of the following: (1) reasons for missing outcome data likely to be related to true outcome, with imbalance in numbers or reasons for missing data across intervention groups; (2) for dichotomous outcome data, proportion of missing outcomes compared with observed event risk enough to induce clinically relevant bias in intervention effect estimate; (3) for continuous outcome data, plausible effect size among missing outcomes enough to induce clinically relevant bias impact on observed effect size; (4) "as-treated" analysis done with substantial departure of the intervention received from that assigned at randomization; or (5) potentially inappropriate application of simple imputation.

"Unclear risk" of bias: reporting of attrition/exclusions insufficient to permit judgment of "low risk" or "high risk."

Selective reporting

"Low risk" of bias: any one of the following: (1) Study protocol was available, and all of the study's prespecified outcomes that were of interest in the review were reported in the prespecified way; or (2) the study protocol was not available, but it was clear that published reports included all expected outcomes, including those that were prespecified.

"High risk" of bias: any one of the following: (1) Not all of the study's prespecified primary outcomes were reported; (2) one or more primary outcomes were reported using measurements, analysis methods, or subsets of data that were not prespecified; (3) one or more reported primary outcomes were not prespecified; (4) one or more outcomes of interest in the review were reported incompletely, so that they could not be entered into a meta-analysis; or (5) the study report failed to include results for a key outcome that would be expected to have been reported for such a study.

"Unclear risk" of bias: information insufficient to permit judgment of "low risk" or "high risk."

Other bias

"Low risk" of bias: Study appeared to be free of other sources of bias.

"High risk" of bias: At least one important risk of bias was present. For example, the study (1) had a potential source of bias related to the specific study design used; or (2) has been claimed to have been fraudulent; or (3) had extreme baseline imbalance; or (4) used blocked randomization in unblinded trials; or (5) had differential diagnostic activity; or (6) had some other problem.

"Unclear risk" of bias: information insufficient to assess whether an important risk of bias existed, or rationale or evidence insufficient to suggest that an identified problem will introduce bias.

Review authors independently assessed risk of bias in included studies and resolved discrepancies through discussion. We made explicit judgments about whether studies were at high risk of bias, according to the criteria given in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011), and we explored the impact of the level of bias by undertaking sensitivity analyses (see Sensitivity analysis).

Measures of treatment effect

For dichotomous data, we have presented results as risk ratios (RRs) with 95% confidence intervals (CIs). For continuous data, we have used mean differences (MDs) with 95% CIs. We calculated the number needed to treat for an additional beneficial or harmful outcome (NNTB or NNTH) for outcomes for which investigators reported a statistically significant reduction or increase in risk difference based on control event rates in the included studies.

Unit of analysis issues

The unit of analysis was the participating infant in individually randomized trials. We had planned to include cluster-randomized trials in the analyses, along with individually randomized trials, but no such trials met our inclusion criteria.

We considered that cross-over trials would not be feasible for this intervention, and consequently, we did not include such trials.

Dealing with missing data

For included studies, we noted levels of attrition in the Characteristics of included studies tables. We analyzed outcomes on an intention-to-treat basis. If this was not clear from the original article, we carried out re-analysis when possible. We contacted study authors for missing data.

Assessment of heterogeneity

We tested heterogeneity of results among studies by using the quantity I2, which describes the percentage of total variation across studies that is due to heterogeneity rather than to chance (Higgins 2003). A value of 0% indicates no observed heterogeneity, whereas I2 values of 50% or greater indicate a substantial level of heterogeneity. We planned to pool data across studies using the fixed-effect model if substantial statistical heterogeneity was not present. If we noted substantial heterogeneity (I2 values ≥ 50%), we used a random-effects model to pool data and made an attempt to identify potential sources of heterogeneity based on subgroup analysis by type of KMC, infant age at initiation of KMC, setting in which the trial was conducted, and risk of bias of trials.

Assessment of reporting biases

We assessed publication and related biases visually by examining the symmetry of funnel plots, and statistically by using Egger's test (Egger 1997). The larger the deviation of the intercept of the regression line from zero, the greater was the asymmetry, and the more likely it was that the meta-analysis would yield biased estimates of effect. We considered a P value < 0.1 to indicate significant asymmetry, as suggested by Egger.

Data synthesis

We performed statistical analyses using Review Manager software (RevMan 2014) and analyzed outcomes on an intention-to-treat basis. If data for similar outcomes from two or more separate studies were available, we combined data in a meta-analysis and calculated a pooled RR or MD with associated 95% CIs.

Quality of evidence

We used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, as outlined in the GRADE Handbook (Schünemann 2013), to assess the quality of evidence for the following (clinically relevant) outcomes: mortality at latest follow-up, severe infection/sepsis at latest follow-up, hypothermia at discharge or at 40 to 41 weeks’ postmenstrual age, weight gain at latest follow-up, any breastfeeding at discharge or at 40 to 41 weeks' postmenstrual age and at one to three months' follow-up, and psychomotor development at 12 months' corrected age (Griffith quotient for all subscales).

Two authors independently assessed the quality of the evidence for each of the outcomes above. We considered evidence from randomized controlled trials as high quality but downgraded the evidence one level for serious (or two levels for very serious) limitations based upon the following: design (risk of bias), consistency across studies, directness of the evidence, precision of estimates and presence of publication bias. We used the GRADEpro 2008 Guideline Development Tool to create a ‘Summary of findings’ table to report the quality of the evidence.

The GRADE approach results in an assessment of the quality of a body of evidence in one of four grades:

  1. High: We are very confident that the true effect lies close to that of the estimate of the effect.

  2. Moderate: We are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.

  3. Low: Our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect.

  4. Very low: We have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

Subgroup analysis and investigation of heterogeneity

We performed prespecified subgroup analyses for the primary outcome of mortality at discharge or at 40 to 41 weeks' postmenstrual age and at latest follow-up according to type of KMC (intermittent vs continuous), daily duration of KMC (< 2 hours vs 6 to 15 hours vs ≥ 20 hours), infant age at initiation of KMC (≤ 10 days vs > 10 days), setting in which the trial was conducted (low/middle-income countries vs high-income countries), and infant stabilization status at trial entry (before vs after). For all outcomes in stabilized LBW infants, we performed subgroup analyses according to type of KMC (intermittent vs continuous). We also compared early-onset KMC (starting within 24 hours post birth) against late-onset KMC (starting after 24 hours post birth).

It was not possible to perform planned subgroup analyses according to birthweight, gestational age, and type of LBW owing to limited available information.

Sensitivity analysis

We carried out a planned sensitivity analysis to explore the impact of risk of bias on the general direction of findings or on the size of the treatment effect for main outcomes when more than one study contributed data. We did this by excluding trials with high risk of bias in their results as judged by the review authors. For the primary outcomes of "mortality at discharge or at 40 to 41 weeks' postmenstrual age," "mortality at latest follow-up," ''severe infection/sepsis at latest follow-up," and "infant growth," we performed sensitivity analyses by excluding trials with unclear allocation concealment and high levels of attrition (> 20%).

Results

Description of studies

See Characteristics of included studies and Characteristics of excluded studies.

Results of the search

In the previous version of this review (Conde-Agudelo 2014), we included 18 trials (Ali 2009; Blaymore Bier 1996; Boo 2007; Cattaneo 1998; Charpak 1997; Eka Pratiwi 2009; Gathwala 2008; Ghavane 2012; Kadam 2005; Nagai 2010; Neu 2010; Ramanathan 2001; Roberts 2000; Rojas 2003; Sloan 1994; Suman 2008; Whitelaw 1988; Worku 2005) and excluded 38 trials (Ahn 2010; Anderson 2003; Arandia 1993; Bera 2014; Bergman 1994; Bergman 2004; Charpak 1994; Chiu 2009; Christensson 1998; Chwo 2002; Dala Sierra 1994; Darmstadt 2006; de Almeida 2010; de Macedo 2007; Feldman 2002; Gregson 2011; Hake Brooks 2008; Huang 2006; Ibe 2004; Kambarami 1998; Kumar 2008; Lai 2006; Lamy Filho 2008; Legault 1993; Legault 1995; Lincetto 2000; Lizarazo-Medina 2012; Ludington-Hoe 1991; Ludington-Hoe 2000; Ludington-Hoe 2004; Ludington-Hoe 2006; Miles 2006; Miltersteiner 2005; Mitchell 2013; Ohgi 2002; Sloan 2008; Tallandini 2006; Udani 2008). For this update, the search strategy identified 16 additional studies for possible inclusion, of which we included three (Acharya 2014; Kumbhojkar 2016; Nimbalkar 2014), added one study to awaiting assessment (Holditch-Davis 2014), and excluded 12 (Badiee 2014; Broughton 2013; Dehghani 2015; Karimi 2014; Kashaninia 2015; Kristoffersen 2016; Lamy Filho 2015; Lyngstad 2014; Mörelius 2015; Samra 2015; Silva 2016; Swarnkar 2016) (Figure 1). One paper by Neu et al (published in 2013) reported additional results of a previously included study (Neu 2010).

Figure 1.

Study flow diagram: review update

Included studies

Twenty-one studies, including 3042 infants, fulfilled inclusion criteria, of which 19 evaluated KMC in LBW infants after stabilization (Acharya 2014; Ali 2009; Blaymore Bier 1996; Boo 2007; Cattaneo 1998; Charpak 1997; Eka Pratiwi 2009; Gathwala 2008; Ghavane 2012; Kadam 2005; Kumbhojkar 2016; Neu 2010; Nimbalkar 2014; Ramanathan 2001; Roberts 2000; Rojas 2003; Sloan 1994; Suman 2008; Whitelaw 1988), one evaluated KMC in LBW infants before stabilization (Worku 2005), and one compared early-onset KMC with late-onset KMC (Nagai 2010) in relatively stable LBW infants. Sixteen studies were conducted in low- or middle-income countries (India (Ali 2009; Gathwala 2008; Ghavane 2012; Kadam 2005; Kumbhojkar 2016; Nimbalkar 2014; Ramanathan 2001; Suman 2008); Ethiopia (Cattaneo 1998; Worku 2005); Malaysia (Boo 2007); Madagascar (Nagai 2010); Indonesia (Cattaneo 1998; Eka Pratiwi 2009); Nepal (Acharya 2014); Ecuador (Sloan 1994); Colombia (Charpak 1997); and Mexico (Cattaneo 1998)), and five in high-income countries (United States (Blaymore Bier 1996; Neu 2010; Rojas 2003); United Kingdom (Whitelaw 1988); and Australia (Roberts 2000)). The sample size ranged from 28 (Ramanathan 2001) to 777 (Charpak 1997) (median, 110). Five studies included infants from multiple pregnancies (Ali 2009; Blaymore Bier 1996; Boo 2007; Charpak 1997; Whitelaw 1988), and six included only infants with birthweight ≤ 1500 g (Blaymore Bier 1996; Boo 2007; Ghavane 2012; Ramanathan 2001; Rojas 2003; Whitelaw 1988). Infants with major congenital malformations or severe perinatal complications and parental refusal to participate in the study were reported as meeting exclusion criteria in the great majority of included studies.

Eight studies did not provide data on the percentage of LBW infants meeting eligibility criteria. Among studies conducted in low- or middle-income countries, 37% (Eka Pratiwi 2009) to 87% (Acharya 2014) of LBW infants met eligibility criteria, whereas for studies conducted in high-income countries, percentages ranged from 19% (Rojas 2003) to 50% (Whitelaw 1988). The mean or median age of LBW infants at enrollment varied from < one hour (Nimbalkar 2014) to 32 days (Roberts 2000) (median, seven days). Median or mean infant age at enrollment was < one day in three studies (Eka Pratiwi 2009; Nimbalkar 2014; Worku 2005), one to 10 days in eight studies (Ali 2009; Cattaneo 1998; Charpak 1997; Gathwala 2008; Kadam 2005; Kumbhojkar 2016; Nagai 2010; Suman 2008), 11 to 20 days in six studies (Ghavane 2012; Neu 2010; Ramanathan 2001; Rojas 2003; Sloan 1994; Whitelaw 1988), and 21 to 32 days in three studies (Blaymore Bier 1996; Boo 2007; Roberts 2000). One study did not report data on infant age at enrollment (Acharya 2014). In the study that compared early-onset KMC with late-onset KMC (Nagai 2010), mean age at initiation of KMC was 19.8 hours in the early-onset KMC group, and 33.0 hours in the late-onset KMC. Mean or median weight of infants at recruitment ranged from 968 g (Blaymore Bier 1996) to 2076 g (Nagai 2010) (median, 1611 g).

Trials were conducted under a variety of hospital conditions, regulations, and routines. However, descriptions of the KMC intervention shows remarkable consistency across trials. In all instances, the intervention included SSC and encouraged breastfeeding. Early neonatal discharge from hospital was considered only in the Colombian study (Charpak 1997). Among studies evaluating KMC in stabilized LBW infants, 16 used intermittent KMC (Acharya 2014; Ali 2009; Blaymore Bier 1996; Boo 2007; Eka Pratiwi 2009; Gathwala 2008; Ghavane 2012; Kadam 2005; Kumbhojkar 2016; Neu 2010; Nimbalkar 2014; Ramanathan 2001; Roberts 2000; Rojas 2003; Suman 2008; Whitelaw 1988), and three used continuous KMC (Cattaneo 1998; Charpak 1997; Sloan 1994). Only one study provided a detailed definition of stabilization (Nagai 2010). The mean or median duration of KMC per day was < two hours in six studies (Blaymore Bier 1996; Boo 2007; Neu 2010; Roberts 2000; Rojas 2003; Whitelaw 1988), four to seven hours in three studies (Acharya 2014; Ali 2009; Ramanathan 2001), eight to 17 hours in seven studies (Eka Pratiwi 2009; Gathwala 2008; Ghavane 2012; Kadam 2005; Kumbhojkar 2016; Nimbalkar 2014; Suman 2008), and ≥ 20 hours in three studies (Cattaneo 1998; Charpak 1997; Sloan 1994). Studies that evaluated KMC in LBW infants before stabilization (Worku 2005) and compared early-onset KMC with late-onset KMC (Nagai 2010) used continuous KMC. In studies evaluating intermittent KMC, the intervention was a combination of SSC and radiant warmer/incubator. Standard neonatal care included infant stay in incubator only (Blaymore Bier 1996; Boo 2007; Charpak 1997; Neu 2010; Roberts 2000; Rojas 2003; Whitelaw 1988) or in radiant warmer only (Acharya 2014; Ali 2009; Kadam 2005; Kumbhojkar 2016; Nimbalkar 2014; Suman 2008; Worku 2005) or in incubator or radiant warmer (Cattaneo 1998; Eka Pratiwi 2009; Gathwala 2008; Ghavane 2012; Ramanathan 2001; Sloan 1994). Information provided to mothers in the conventional neonatal care group on promotion of breastfeeding and on facilitation and promotion of maternal involvement in the care of the neonate, which are critical for the outcomes measured, was not reported in eight trials (Acharya 2014; Blaymore Bier 1996; Charpak 1997; Eka Pratiwi 2009; Kumbhojkar 2016; Nagai 2010; Suman 2008; Worku 2005).

Eleven studies were performed in neonatal intensive care units of tertiary care, public, maternity, or university hospitals (Ali 2009; Boo 2007; Eka Pratiwi 2009; Kadam 2005; Kumbhojkar 2016; Ramanathan 2001; Roberts 2000; Rojas 2003; Sloan 1994; Suman 2008; Whitelaw 1988), four in neonatal units of university hospitals (Cattaneo 1998; Gathwala 2008; Nagai 2010; Worku 2005), two in "kangaroo wards" (KMC infants) and neonatal intensive/intermediate care units of tertiary care hospitals (controls) (Charpak 1997; Ghavane 2012), two in newborn nurseries (Acharya 2014; Blaymore Bier 1996), one in a maternity ward (Nimbalkar 2014), and one in both hospital and home (Neu 2010). Infants were cared for by both doctors and nurses in all but two studies (Ghavane 2012; Neu 2010). In the Ghavane 2012 study, infants in the KMC group were cared for solely by their mothers, who was supervised by a trained nurse. In the Neu 2010 study, the supportive intervention that promoted kangaroo holding of preterm infants by their mothers was performed by an experienced nurse. Nine studies reported clearly on criteria for discharging infants from the hospital (Ali 2009; Boo 2007; Cattaneo 1998; Charpak 1997; Ghavane 2012; Kadam 2005; Kumbhojkar 2016; Ramanathan 2001; Suman 2008). The most commonly reported criteria were (1) good general health of the infant without overt illness; (2) feeding well on exclusive or predominant breastfeeding; (3) weight gain of 10 to 15 g/kg/d for ≥ three consecutive days; (4) stable temperature for ≥ three consecutive days; and (5) mother confident of taking care of the infant at home. In addition, three studies included an infant weight of ≥ 1300 to 1500 g as a discharge criterion. Thirteen studies reported on schemes for follow-up of infants after discharge from the hospital (Ali 2009; Blaymore Bier 1996; Cattaneo 1998; Charpak 1997; Gathwala 2008; Ghavane 2012; Kumbhojkar 2016; Nagai 2010; Neu 2010; Roberts 2000; Sloan 1994; Suman 2008; Whitelaw 1988). In summary, the most common scheme for follow-up was the following: weekly until 40 weeks' postmenstrual age, and monthly thereafter until three to six months of age or corrected age. In five studies, the last follow-up was provided at six months of age or corrected age (Ali 2009; Blaymore Bier 1996; Neu 2010; Roberts 2000; Sloan 1994). Infants were followed up to 12 months of age or corrected age in only two studies (Charpak 1997; Whitelaw 1988).

The main characteristics of the included studies are shown in the table Characteristics of included studies.

Excluded studies

We excluded 50 studies: 21 because they were non-randomized trials (Ahn 2010; Arandia 1993; Bera 2014; Bergman 1994; Broughton 2013; Charpak 1994; Dala Sierra 1994; de Almeida 2010; de Macedo 2007; Feldman 2002; Gregson 2011; Ibe 2004; Kashaninia 2015; Kristoffersen 2016; Lamy Filho 2008; Legault 1995; Lincetto 2000; Lizarazo-Medina 2012; Ohgi 2002; Silva 2016; Tallandini 2006), 10 because they included infants with birthweight ≥ 2500 g and did not report results separately for the subgroup of infants with birthweight < 2500 g (Anderson 2003; Chiu 2009; Chwo 2002; Hake Brooks 2008; Huang 2006; Karimi 2014; Lai 2006; Mörelius 2015; Samra 2015; Sloan 2008), seven because they reported only physiological outcomes (Bergman 2004; Dehghani 2015; Ludington-Hoe 1991; Ludington-Hoe 2000; Ludington-Hoe 2004; Ludington-Hoe 2006; Mitchell 2013), three because the method of generation of allocation to treatment was quasi-randomized (Kambarami 1998; Miltersteiner 2005; Swarnkar 2016), three because allocation was performed by a cross-over design (Legault 1993; Lyngstad 2014; Miles 2006), two because KMC was part of a preventive package of interventions for essential newborn care (Darmstadt 2006; Kumar 2008), one because it evaluated only KMC for rewarming hypothermic infants (Christensson 1998), one because it assessed only the effect of KMC on the mental health of mothers (Badiee 2014), one because it evaluated only the effect of KMC on colonization status of newborns’ nostrils (Lamy Filho 2015), and one because it was published as an abstract only, and our attempts to locate full publications or to contact study authors were unsuccessful (Udani 2008).

We have presented the main characteristics of the excluded studies in the table Characteristics of excluded studies.

Risk of bias in included studies

We have depicted the risk of bias in included studies in Figure 2. We judged that no study adequately addressed all seven domains. We judged only two studies to adequately address six domains. The methodological quality of the included trials was mixed, and we carried out a sensitivity analysis to examine the impact of excluding trials at high risk of bias. See Sensitivity analysis. The main threats to validity were performance bias (by lack of blinding of participants, personnel, and outcomes assessors) and selection bias (by lack of information on methods used for concealment of treatment allocation).

Figure 2.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Allocation

Most of the included studies used adequate methods to generate allocation sequence. Ten studies used random number tables (Acharya 2014; Cattaneo 1998; Charpak 1997; Eka Pratiwi 2009; Gathwala 2008; Nimbalkar 2014; Ramanathan 2001; Rojas 2003; Sloan 1994; Worku 2005), and four studies used shuffling of envelopes (Blaymore Bier 1996; Boo 2007; Roberts 2000; Whitelaw 1988). Other methods of sequence generation used included web-based random number generator (Ghavane 2012), computer random number generator (Neu 2010), minimization computerized technique (Nagai 2010), block randomization technique (Ali 2009), the sealed envelope method (Kadam 2005), and simple randomization (Kumbhojkar 2016; Suman 2008).

Ten studies used sealed envelopes for concealment of treatment allocation (Boo 2007; Ghavane 2012; Kadam 2005; Kumbhojkar 2016; Neu 2010; Nimbalkar 2014; Roberts 2000; Rojas 2003; Suman 2008; Whitelaw 1988), although only five studies (Ghavane 2012; Neu 2010; Nimbalkar 2014; Rojas 2003; Whitelaw 1988) explicitly stated that the envelopes were opaque, sealed, and numbered. Investigators concealed allocation by using a software that provided automatically random allocation (minimization method) in only one study (Nagai 2010). Ten studies did not report the method of allocation concealment (Acharya 2014; Ali 2009; Blaymore Bier 1996; Cattaneo 1998; Charpak 1997; Eka Pratiwi 2009; Gathwala 2008; Ramanathan 2001; Sloan 1994; Worku 2005).

Blinding

As KMC cannot be implemented when masked, all included studies reported lack of blinding of participants and clinical staff. Only two studies (Ghavane 2012; Nagai 2010) reported that outcome assessors were masked to the intervention group of infants. Neu 2010 reported that four researchers assessed outcome measures, two of whom were blinded to the hypotheses of the study but not to group assignment of mother-infant dyads. The other two researchers were blinded to group assignment and hypotheses. The remaining trials did not state whether any attempt was made to "blind" outcome assessment.

We consider that performance and observer bias cannot be excluded owing to lack of blinding of participants and clinicians. However, although this could affect assessment of subjective outcomes such as parental and familial satisfaction, mother-infant attachment, and social and home environment, or objective outcomes such as breastfeeding, length of hospital length, and re-admission to hospital after discharge, it is much less likely to have affected the primary outcomes (infant mortality, severe infection/sepsis, severe illness, infant growth, and neurodevelopmental disability) and some secondary outcomes of this review (nosocomial infection, mild/moderate infection or illness, hypothermia, and hyperthermia).

Incomplete outcome data

Eight trials had no losses to follow-up and no exclusions post randomization (Acharya 2014; Kadam 2005; Nagai 2010; Nimbalkar 2014; Ramanathan 2001; Roberts 2000; Rojas 2003; Whitelaw 1988). In seven studies, 1% to 10% of recruited infants were lost to follow-up (Ali 2009; Blaymore Bier 1996; Charpak 1997; Eka Pratiwi 2009; Gathwala 2008; Ghavane 2012; Sloan 1994). Boo 2007 excluded 12.3% of infants in the KMC group because SSC sessions were carried out on less than 50% of hospital stay days after recruitment. Two trials (Cattaneo 1998; Worku 2005) did not report the number of infants lost to follow-up or excluded after randomization. Kumbhojkar 2016 did not report the number of infants lost to follow-up or exclusions, but investigators stated in the Discussion section of the article that "poor follow-up" was provided in the control group. Suman 2008 had high risk of attrition bias because 22.3% of infants were lost to follow-up. Moreover, imbalance across intervention groups was evident in numbers for losses to follow-up (KMC 10.2%; control 33.9%). In addition, 6.4% of infants were omitted from reports of analyses because they did not receive assigned care. Neu 2010 had high risk of attrition bias because 9.2% of infants were lost to follow-up and 16.1% were excluded post randomization.

Selective reporting

No study protocols were available. We compared outcomes listed in the Methods section of articles against those reported in the Results section. Sixteen studies (Acharya 2014; Blaymore Bier 1996; Boo 2007; Cattaneo 1998; Charpak 1997; Eka Pratiwi 2009; Gathwala 2008; Ghavane 2012; Kadam 2005; Kumbhojkar 2016; Nagai 2010; Neu 2010; Nimbalkar 2014; Roberts 2000; Rojas 2003; Suman 2008) reported all outcomes listed in the Methods section, and we assume that these reports probably included all prespecified variables. Two studies (Ali 2009; Worku 2005) had high risk of bias owing to selective outcome reporting. Worku 2005 did not report the great majority of outcomes listed in the Methods section, such as mild/moderate and severe illness, sepsis, diarrhea, pneumonia, aspiration, weight gain, and mother's feelings. In Ali 2009, non-significant results such as infant mortality (primary outcome) and weight, length, and head circumference at discharge and follow-up (secondary outcomes) were mentioned but were not reported adequately. In the remaining three studies, some secondary outcomes listed in the Methods section were not reported (Ramanathan 2001), or they were mentioned but were not reported adequately (Sloan 1994; Whitelaw 1988).

Other potential sources of bias

We did not identify other potential sources of bias in 15 studies (Acharya 2014; Blaymore Bier 1996; Boo 2007; Gathwala 2008; Ghavane 2012; Kadam 2005; Kumbhojkar 2016; Nagai 2010; Neu 2010; Nimbalkar 2014; Ramanathan 2001; Roberts 2000; Rojas 2003; Whitelaw 1988; Worku 2005). Three studies (Ali 2009; Charpak 1997; Eka Pratiwi 2009) used blocked randomization for sequence generation. When blocked randomization is used in an unblinded trial, and when assignments are revealed after individuals are recruited into the trial, it is sometimes possible to predict future assignments. This is particularly the case when blocks are of a fixed size. Cattaneo 1998 carried out randomization in blocks of six with stratification by weight at one of the three participating centers. The trial performed by Sloan 1994 was stopped early because investigators found a highly significant difference in severe morbidity at two months and at six months. Randomized controlled trials that are stopped early are more likely to be associated with greater effect sizes than RCTs not stopped early (Bassler 2010). This difference is independent of the presence of statistical stopping rules and is greatest in smaller studies. In the study by Suman 2008, groups were significantly different at baseline in weight and age at enrollment.

Effects of interventions

See: Summary of findings for the main comparison Kangaroo mother care versus conventional neonatal care for reducing morbidity and mortality in low birthweight infants

Comparison 1. Kangaroo mother care versus conventional neonatal care

The comparison between KMC and conventional neonatal care included 20 studies (2969 infants) and 49 outcomes, of which 24 were reported in more than one study.

Mortality (outcomes 1.1 to 1.4)

Kangaroo mother care was associated with a statistically significant reduction in risk of mortality at discharge or at 40 to 41 weeks’ postmenstrual age (3.2% vs 5.3%; RR 0.60, 95% CI 0.39 to 0.92; I2 = 0%; NNTB = 47, 95% CI 31 to 236; eight trials, 1736 infants) (Analysis 1.1), and at latest follow-up (4.0% vs 6.0%; RR 0.67, 95% CI 0.48 to 0.95; I2 = 0%; NNTB = 50, 95% CI 32 to 331; 12 trials, 2293 infants; moderate-quality evidence) (Analysis 1.4) (Figure 3). The significantly decreased risk of death at discharge or at 40 to 41 weeks’ postmenstrual age, and at latest follow-up, was also demonstrated in the subgroup of studies that used continuous (≥ 20 hours/d) KMC (mortality at discharge or at 40 to 41 weeks’ postmenstrual age: RR 0.60, 95% CI 0.38 to 0.96; I2 = 0%; three trials, 1117 infants; mortality at latest follow-up: RR 0.67, 95% CI 0.46 to 0.98; I2 = 0%; four trials, 1384 infants), the subgroup of studies in which KMC was initiated within 10 days post birth (mortality at discharge or at 40 to 41 weeks’ postmenstrual age: RR 0.56, 95% CI 0.36 to 0.88; I2 = 0%; five trials, 1412 infants; mortality at latest follow-up: RR 0.56, 95% CI 0.37 to 0.85; I2 = 0%; six trials, 1489 infants), the subgroup of studies conducted in low/middle-income countries (mortality at discharge or at 40 to 41 weeks’ postmenstrual age: RR 0.57, 95% CI 0.37 to 0.89; I2 = 0%; seven studies, 1676 infants; mortality at latest follow-up: RR 0.65, 95% CI 0.45 to 0.93; I2 = 0%; 10 trials, 2162 infants), and the trial in which KMC was used in unstabilized infants (RR 0.57, 95% CI 0.33 to 1.00). The statistically significant beneficial effect of KMC on mortality at discharge or at 40 to 41 weeks’ postmenstrual age and on mortality at latest follow-up was not demonstrated in the subgroup of trials that used intermittent KMC (< 2 hours/d and between 6 and 15 hours/d), or that initiated KMC after 10 days post birth, or that were conducted in high-income countries, or that used KMC in stabilized infants.

Figure 3.

Forest plot of comparison: 1 Kangaroo mother care versus conventional neonatal care, outcome: 1.1 Mortality at latest follow-up.

The sensitivity analysis limited to studies with adequate concealment of allocation revealed a similar reduction in mortality at discharge or at 40 to 41 weeks’ postmenstrual age, and at latest follow-up, although this was not statistically significant (mortality at discharge or at 40 to 41 weeks’ postmenstrual age: RR 0.59, 95% CI 0.19 to 1.81; I2 = 0%; five trials; mortality at latest follow-up: RR 0.68, 95% CI 0.26 to 1.77; I2 = 0%; six trials). Similar results were obtained when we excluded studies with high risk of attrition bias (mortality at discharge or at 40 to 41 weeks’ postmenstrual age: RR 0.64, 95% CI 0.41 to 1.00; I2 = 0%; six studies; mortality at latest follow-up: RR 0.71, 95% CI 0.49 to 1.01; I2 = 0%; 10 studies).

We found no overall difference in risk of mortality at six months of age or at six months' follow-up (RR 0.99, 95% CI 0.48 to 2.02; two trials, 354 infants) (Analysis 1.2), and at 12 months’ corrected age (RR 0.57, 95% CI 0.27 to 1.17; one trial, 693 infants) (Analysis 1.3) between KMC infants and controls.

Infection/illness (outcomes 1.5 to 1.14)

In stabilized LBW infants, KMC was associated with a statistically significant reduction in severe infection/sepsis at latest follow-up (6.6% vs 13.1%; RR 0.50, 95% CI 0.36 to 0.69; I2 = 24%; NNTB = 15, 95% CI 12 to 25; eight trials, 1463 infants; moderate-quality evidence) (Analysis 1.5) (Figure 4), severe illness at six months' follow-up (5.3% vs 17.8%; RR 0.30, 95% CI 0.14 to 0.67; NNTB = 8, 95% CI 7 to 17; one trial, 283 infants) (Analysis 1.6), nosocomial infection/sepsis at discharge or at 40 to 41 weeks’ postmenstrual age (4.0% vs 11.4%; RR 0.35, 95% CI 0.22 to 0.54; I2 = 0%; NNTB = 14, 95% CI 11 to 19; five trials, 1239 infants) (Analysis 1.7), lower respiratory tract disease at six months' follow-up (4.6% vs 12.5%; RR 0.37, 95% CI 0.15 to 0.89; NNTB = 13, 95% CI 9 to 73; one trial, 283 infants) (Analysis 1.9), and hypothermia at discharge or at 40 to 41 weeks' postmenstrual age (7.6% vs 27.1%; RR 0.28, 95% CI 0.16 to 0.49; I2 = 52%; NNTB = 5, 95% CI 4 to 7; nine trials, 989 infants; moderate-quality evidence) (Analysis 1.11).

Figure 4.

Forest plot of comparison: 1 Kangaroo mother care versus conventional neonatal care, outcome: 1.2 Severe infection/sepsis at latest follow-up - stabilized infants.

Only the subgroup of trials that used intermittent KMC demonstrated significantly reduced risk of severe infection/sepsis at latest follow-up and hypothermia at discharge or at 40 to 41 weeks' postmenstrual age. Subgroups of trials that used intermittent or continuous KMC showed a statistically significantly reduced risk of nosocomial infection/sepsis at discharge or at 40 to 41 weeks’ postmenstrual age. 

We found no overall difference between KMC infants and controls in risk of mild/moderate infection or illness at latest follow-up (RR 1.28, 95% CI 0.87 to 1.88) (Analysis 1.8), diarrhea at six months' follow-up (RR 0.65, 95% CI 0.35 to 1.20) (Analysis 1.10), hyperthermia at discharge or at 40 to 41 weeks' postmenstrual age (RR 0.79, 95% CI 0.59 to 1.05) (Analysis 1.12), and re-admission to hospital at latest follow-up (RR 0.60, 95% CI 0.34 to 1.06) (Analysis 1.14).

Intermittent KMC decreased length of hospital stay by 1.6 days, although this difference was not statistically significant (95% CI -0.2 to 3.4; P value = 0.08; 11 studies, 1057 infants) (Analysis 1.13). Mean hospital stay from randomization to 41 weeks' postmenstrual age was 4.5 days for KMC infants and 5.6 days for control infants in Charpak 1997. Investigators provided no standard deviations. Cattaneo 1998 reported only median hospital stay, which was 11 days in the KMC group versus 13 days in the control group. Length of hospital stay was two days greater in KMC infants than in control infants in Sloan 1994.

Sensitivity analyses using only studies with adequate allocation concealment demonstrated a similar result for severe infection/sepsis at latest follow-up (RR 0.40, 95% CI 0.24 to 0.66) and for hypothermia at discharge or at 40 to 41 weeks' postmenstrual age (RR 0.24, 95% CI 0.16 to 0.36). Additional sensitivity analyses did not indicate that removing the study with high risk of attrition bias (Suman 2008) had any important impact on overall effects of KMC on severe infection/sepsis at latest follow-up (RR 0.54, 95% CI 0.38 to 0.76) and on hypothermia at discharge or at 40 to 41 weeks' postmenstrual age (RR 0.33, 95% CI 0.23 to 0.48).

Infant growth (outcomes 1.15 to 1.26)

Infants given kangaroo mother care gained more weight per day (MD 4.1 g, 95% CI 2.3 to 5.9; 11 trials, 1198 infants; moderate-quality evidence) (Analysis 1.18) (Figure 5) and had greater increases in length (MD 0.21 cm, 95% CI 0.03 to 0.38; three trials, 377 infants) (Analysis 1.22) and head circumference (MD 0.14 cm, 95% CI 0.06 to 0.22; four trials, 495 infants) (Analysis 1.26) per week than controls. Nevertheless, considerable heterogeneity was evident (I2 > 70%) among trials reporting gain in weight, length, and head circumference. One trial (Charpak 1997) reported that KMC infants had a larger head circumference at 6 months' corrected age than controls (MD 0.34 cm, 95% CI 0.11 to 0.57; 592 infants) (Analysis 1.24). Investigators observed no differences in weight, length, or head circumference at discharge or at 40 to 41 weeks' postmenstrual age (Analysis 1.15; Analysis 1.19; Analysis 1.23) or at 12 months' corrected age (Analysis 1.17; Analysis 1.21; Analysis 1.25), or in weight or length at 6 months’ corrected age (Analysis 1.16; Analysis 1.20). Sloan 1994 reported, "there were no significant differences between the groups in growth indices during the six-month follow up."

Figure 5.

Forest plot of comparison: 1 Kangaroo mother care versus conventional neonatal care, outcome: 1.10 Weight gain at latest follow-up (g/d) - stabilized infants.

We undertook sensitivity analysis by excluding studies with unclear allocation concealment and high risk of attrition bias to examine the impact on increases in both weight and head circumference. We found no differences in the overall direction of findings.

Neurodevelopmental and neurosensory impairment (outcomes 1.27 to 1.30)

Only one study (Charpak 1997) reported results for neurodevelopmental and neurosensory impairment at one year of corrected age. Researchers found no statistically significant differences between KMC infants and controls in Griffith quotients for psychomotor development (low-quality evidence) (Analysis 1.27), cerebral palsy (Analysis 1.28), deafness (Analysis 1.29), and visual impairment (Analysis 1.30). A secondary publication of the Charpak 1997 trial reported that the subgroup of KMC infants with birthweight ≤ 1800 g had a higher general developmental quotient than controls at one year of corrected age (P value < 0.01).

Breastfeeding (outcomes 1.31 to 1.40)

Mothers of KMC infants were more likely to be breastfeeding at discharge or at 40 to 41 weeks' postmenstrual age and at one to three months' follow-up than mothers in the control group. Compared with conventional care, KMC was associated with an increase in the likelihood of exclusive breastfeeding at discharge or at 40 to 41 weeks' postmenstrual age (66.3% vs 56.3%; RR 1.16, 95% CI 1.07 to 1.25; I2 = 39%; NNTB = 11, 95% CI 7 to 25; six studies, 1453 mothers) (Analysis 1.31), and at one to three months' follow-up (86.9% vs 76.5%; RR 1.20, 95% CI 1.01 to 1.43; I2 = 76%; NNTB = 7, 95% CI 3 to 131; five studies, 600 mothers) (Analysis 1.32), or any (exclusive or partial) breastfeeding at discharge or at 40 to 41 weeks' postmenstrual age (88.9% vs 76.2%; RR 1.20, 95% CI 1.07 to 1.34; I2 = 80%; NNTB = 7, 95% CI 4 to 19; 10 studies, 1696 mothers; moderate-quality evidence) (Analysis 1.34) (Figure 6), at one to two months' follow-up (77.9% vs 67.9%; RR 1.33, 95% CI 1.00 to 1.78; I2 = 78%; six studies, 538 mothers) (Analysis 1.35), at 3 months' follow-up (79.7% vs 69.8%; RR 1.14, 95% CI 1.06 to 1.23; I2 = 41%; five studies, 924 mothers) (Analysis 1.36), and at one to three months' follow-up (80.4% vs 71.1%; RR 1.17, 95% CI 1.05 to 1.31; I2 = 62%; NNTB = 8, 95% CI 5 to 28; nine studies, 1394 mothers; low-quality evidence) (Analysis 1.37). It should be noted that heterogeneity was substantial (I2 > 50%) among trials reporting breastfeeding. Overall, investigators found no statistically significant differences between KMC and control for exclusive or any breastfeeding at six to 12 months' follow-up (Analysis 1.33; Analysis 1.38; Analysis 1.39) and at onset of breastfeeding (Analysis 1.40). However, subgroup analyses showed that intermittent KMC was associated with a significant increase in exclusive breastfeeding at six to 12 months' follow-up (84.6% vs 55.6%; RR 1.52, 95% CI 1.10 to 2.10; one study, 75 women) and in any breastfeeding at six months' follow-up (54.7% vs 36.8%; RR 1.50, 95% CI 1.08-2.08; three studies, 143 women).

Figure 6.

Forest plot of comparison: 1 Kangaroo mother care versus conventional neonatal care, outcome: 1.34 Any breastfeeding at discharge or at 40 to 41 weeks' postmenstrual age - stabilized infants.

Statistically significant positive effects of KMC on breastfeeding at discharge or at 40 to 41 weeks' postmenstrual age and at one to three and six months' follow-up were demonstrated in the subgroup of trials that used intermittent KMC but not in the subgroup of trials that used continuous KMC. In addition, an increase in the likelihood of any breastfeeding at one to two months' follow-up was demonstrated in the subgroup of three trials (131 infants) conducted in high-income countries (RR 2.02, 95% CI 1.28 to 3.21; I2 = 23%).

Parental and familial satisfaction (outcome 1.41)

Only one study (Cattaneo 1998) evaluated parental and familial satisfaction with method of infant care. Mothers in the KMC group were more satisfied with the method of care than were mothers in the control group (91% vs 78%; RR 1.17, 95% CI 1.05 to1.30; 269 mothers) (Analysis 1.41). Investigators found no significant differences in satisfaction with method of care between fathers and families of KMC and control groups.

Mother-infant attachment or interaction (outcomes 1.42 to 1.49)

Three studies (Charpak 1997; Gathwala 2008; Roberts 2000) reported results on mother-infant attachment, and one (Neu 2010) on mother-infant interaction.

A secondary publication of the Charpak 1997 trial reported two series of outcomes that were assessed as manifestations of mother-infant attachment. The first was the mother's feelings and perceptions of her premature birth experience, measured through a "mother's perception of premature birth questionnaire" using a Likert scale (1 to 5), 24 hours after birth and when the infant reached 41 weeks' postmenstrual age. The second outcome was derived from observations of the mother's and child's responsiveness to each other during breastfeeding, using a "nursing child assessment feeding scale." Researchers compared a total of nine items between KMC and control groups according to the interval between birth and start of the intervention (one to two days, three to 14 days, and longer than 14 days), as well as admission of the infant to the neonatal intensive care unit (NICU) (yes or not), for a total of 45 comparisons. Overall, scores on six comparisons (mother's sense of competence [interval between birth and start of intervention of one to two days], mother's sense of competence [infant admitted to NICU], mother's sense of competence [infant not admitted to NICU], mother’s feelings of worry and stress [interval between birth and start of intervention of one to two days], mother’s sensitivity [interval between birth and start of intervention > 14 days], and infant responsiveness [interval between birth and start of intervention > 14 days]) were significantly higher in the KMC group than in the control group. Scores on two comparisons (mother’s perceptions of social support [interval between birth and start of intervention > 14 days, and infant not admitted to NICU]) were significantly lower in the KMC group than in the control group. Results showed no significant differences in scores for the remaining 37 comparisons (Analysis 1.42; Analysis 1.43; Analysis 1.44).

Gathwala 2008 evaluated mother-infant attachment at three months' follow-up through a structured maternal interview that used attachment questions scored in such a manner that a higher score indicated greater attachment. The total attachment score for the KMC group (24.46 ± 1.64) was significantly higher than that obtained for the control group (18.22 ± 1.79) (Analysis 1.45).   

Roberts 2000 measured maternal stress levels in the NICU and mothers' perceptions of their maternal competence. Only the score on the scale for "relationship with the infant" was significantly higher in the KMC group (4.4 ± 0.46) than in the control group (3.4 ± 1.16). Researchers found no significant differences between KMC and control group scores on nursery environment, infant appearance, staff behavior and communication, and parental confidence in their parenting abilities (Analysis 1.46; Analysis 1.47).

Neu 2010 evaluated the mother-infant interaction at six months of age by using the Stiil-Face Paradigm tool. Mother-infant dyads in the KMC group showed more symmetrical, and less asymmetrical, co-regulation than mother-infant dyads in the control group (Analysis 1.48). Multivariate analysis showed no differences between groups in infant vitality during the neutral face portion of the Stiil-Face procedure. A secondary publication of the Neu 2010 study reported that KMC infants had similar scores for behavioral regulation and development to those of infants who experienced nurse-supported blanket holding at 40 to 44 weeks' postmenstrual age (Analysis 1.49).

Home environment and father involvement (outcome 1.50)

One trial (Charpak 1997) evaluated home environment and father involvement at 12 months' corrected age through a structured interview administered to parents during a home visit. The total Home Observation for Measurement of the Environment (HOME) score was significantly higher among kangaroo families (0.28 ± 0.24) than in conventional care families (-0.51 ± 0.26) (Analysis 1.50). Scores on father involvement were not reported, but study authors claimed that KMC increased father involvement (the father's sense of responsibility and competence).

Costs of care

No study reported data on mean (SD) total medical and non-medical costs for KMC and control groups. The overall cost was "about 50% less for KMC" in the Cattaneo 1998 study. Specifically, the cost was US $19,289 for KMC and US $39,764 for conventional care. In the Sloan 1994 study, "costs of neonatal care were greater in the control than in the KMC group." Overall, the cost of hospital stay and postneonatal care at five months was US $741 greater for the control than the KMC group. However, data were available for only 49 infants (24 KMC, 25 control) at six months' follow-up.

All funnel plots showed no asymmetry, either visually or in terms of statistical significance (P value > 0.10 for all, by Egger's test).

Comparison 2. Early-onset kangaroo mother care versus late-onset kangaroo mother care in relatively stable infants

Only one trial (Nagai 2010), which was considered at low risk of bias, compared early-onset KMC versus late-onset KMC in relatively stable LBW infants. Early continuous KMC was begun as soon as possible, within 24 hours post birth, and late continuous KMC was begun after complete stabilization, generally after 24 hours post birth. This study included a total of 73 LBW infants (early 37, late 36). Investigators reported no statistically significant differences between early-onset KMC and late-onset KMC for mortality at four weeks of age (RR 1.95, 95% CI 0.18 to 20.53) (Analysis 2.1) and at six months of age (RR 1.00, 95% CI 0.15 to 6.72) (Analysis 2.10), morbidity (RR 0.49, 95% CI 0.18 to 1.28) (Analysis 2.2) and severe infection (RR 0.42, 95% CI 0.12 to 1.49) (Analysis 2.3) at four weeks of age, re-admission to hospital at four weeks of age (RR 1.95, 95% CI 0.18 to 20.53) (Analysis 2.4) and at six to 12 months of age (RR 1.00, 95% CI 0.32 to 3.16) (Analysis 2.11), hypothermia (RR 0.58, 95% CI 0.15 to 2.27) (Analysis 2.5), hyperthermia (RR 1.05, 95% CI 0.56 to 1.99) (Analysis 2.6), weight gain at four weeks of age (MD 58.9 g, 95% CI -116.9 to 234.6) (Analysis 2.7), exclusive breastfeeding at four weeks of age (RR 0.94, 95% CI 0.85 to 1.04) (Analysis 2.8), and stunting (RR 0.83, 95% CI 0.46 to 1.48) (Analysis 2.12), severe stunting (RR 0.67, 95% CI 0.17 to 2.73) (Analysis 2.13), wasting (RR 0.10, 95% CI 0.01 to 1.77) (Analysis 2.14), severe wasting (RR 0.00, 95% CI 0.00 to 0.00) (Analysis 2.15), underweight (RR 0.49, 95% CI 0.21 to 1.14) (Analysis 2.16), and severe underweight (RR 0.22, 95% CI 0.03 to 1.88) (Analysis 2.17) at six to 12 months of age. However, compared with late-onset KMC, early-onset KMC was associated with a statistically significant reduction in body weight loss from birth to 48 hours post birth (MD 43.3 g, 95% CI 5.5 to 81.1) (Analysis 2.7) and in length of hospital stay (MD 0.9 days, 95% CI 0.6 to 1.2) (Analysis 2.9). In addition, early-onset KMC was associated with a non-significant increase in the likelihood of exclusive breastfeeding at six months of age (41.4% vs 15.4%; RR 2.69, 95% CI 0.99 to 7.31) (Analysis 2.8).

Discussion

Summary of main results

This updated systematic review of 20 randomized controlled trials (RCTs) comparing kangaroo mother care (KMC) and conventional neonatal care found compelling evidence that KMC is associated with a reduction in mortality at discharge or at 40 to 41 weeks' postmenstrual age and at latest follow-up, severe infection/sepsis, and hypothermia, and an increase in weight gain and in exclusive or any breastfeeding at discharge or at 40 to 41 weeks' postmenstrual age and at one to three months' follow-up. Moreover, growing evidence indicates that KMC reduces the risk of nosocomial infection/sepsis at discharge or at 40 to 41 weeks’ postmenstrual age, and increases the gain in length and head circumference, maternal satisfaction with the method, maternal-infant attachment, and home environment. One trial (Charpak 1997) reported no significant differences between KMC infants and controls in a variety of neurodevelopmental and neurosensory outcomes at one year of corrected age.

Overall, continuous KMC led to a reduction in mortality at discharge or at 40 to 41 weeks' postmenstrual age and at latest follow-up, and in nosocomial infection/sepsis, severe illness, and lower respiratory tract disease, and an increase in weight gain, maternal satisfaction with the method, and some measures of mother-infant attachment and home environment. On the other hand, intermittent KMC was associated with a decrease in the risk of severe infection/sepsis, nosocomial infection/sepsis, and hypothermia, and an increase in weight, length, and head circumference gain, exclusive or any breastfeeding at discharge or 40 to 41 weeks' postmenstrual age and at one to three months' follow-up, and mother-infant attachment at three months' follow-up.

Subgroup analyses showed that decreased risk of death at discharge or at 40 to 41 weeks' postmenstrual age and at latest follow-up was demonstrated in the subgroup of trials that used continuous KMC (≥ 20 hours/d), the subgroup of trials in which KMC was initiated within 10 days post birth, the subgroup of trials conducted in low/middle-income countries, and the trial in which KMC was used in unstabilized infants. Sensitivity analysis suggested that inclusion of studies with high risk of bias did not affect the general direction of findings nor the size of the treatment effect, although the beneficial effect of KMC on mortality turned non-significant or marginally significant.

One small high-quality trial (Nagai 2010) suggested that early-onset KMC, compared with late-onset KMC, is associated with a significant reduction in body weight loss from birth to 48 hours post birth and in length of hospital stay, and a marginally significant increase in the likelihood of exclusive breastfeeding at six months of age, with no significant difference in mortality, morbidity, severe infection, re-admission to hospital, hypothermia, hyperthermia, exclusive breastfeeding at four weeks of age, or infant nutritional indicators at six to 12 months of age.

Overall completeness and applicability of evidence

Participants in the included trials reflect the population for which this intervention is currently considered, that is, low birthweight (LBW)/preterm infants. Sixteen trials, including all five trials that evaluated continuous KMC, were conducted in hospitals in low/middle-income countries. Mortality at discharge was the only outcome reported in the sole trial (Worku 2005) that compared KMC with conventional neonatal care in LBW infants before stabilization. The remaining 48 outcomes were reported in 19 trials that evaluated KMC in stabilized LBW infants. We were unable to draw conclusions about the effectiveness of KMC in unstabilized LBW infants. Given these factors, the great majority of results of our meta-analysis can be applied only to stabilized LBW infants in low/middle-income countries. However, the beneficial effect of KMC on any breastfeeding at one to two months' follow-up was also found among stabilized LBW infants in high-income countries.

As only a small trial compared early-onset KMC with late-onset KMC, review authors could draw no firm conclusions regarding apparent differences between these two types of management.

One randomized controlled cluster trial (Sloan 2008) assessed the effect of community-based KMC on overall neonatal mortality, infant mortality, and LBW neonatal mortality; investigators assigned 4165 infants in rural Bangladesh to community-based KMC or control without KMC. Unfortunately, we did not include this study in the review because 40% overall and 65% of newborns who died were not weighed at birth, and missing birthweight was differential for study group. Results show no difference in overall neonatal mortality rate or infant mortality rate. However, for infants whose modeled birthweight was ≤ 2000 g, the neonatal mortality rate was 9.5% in the community-based KMC group and 22.5% in the control group (adjusted odds ratio 0.37, 95% confidence interval [CI] 0.16 to 0.86).

Quality of the evidence

Overall, we assessed the quality of the evidence as moderate for most critical and important outcomes (Summary of findings for the main comparison). We evaluated the risk of bias in included studies by addressing seven specific domains (random sequence generation, allocation concealment, blinding of participants and personnel, blinding of outcome assessment, incomplete outcome data, selective reporting, and other bias) discussed in section Risk of bias in included studies. Review authors judged that 12 studies adequately addressed at least four domains (Acharya 2014; Blaymore Bier 1996; Boo 2007; Ghavane 2012; Kadam 2005; Kumbhojkar 2016; Nagai 2010; Neu 2010; Nimbalkar 2014; Roberts 2000; Rojas 2003; Whitelaw 1988). Five studies adequately addressed three domains (Charpak 1997; Eka Pratiwi 2009; Gathwala 2008; Ramanathan 2001; Suman 2008), and four adequately addressed two or fewer domains (Ali 2009; Cattaneo 1998; Sloan 1994; Worku 2005).

Overall, the quality of the studies was mixed, although sensitivity analysis suggests that inclusion of studies with high risk of bias did not affect the general direction of findings nor the size of the treatment effect. Nevertheless, lack of blinding of outcome assessors in most studies and the unclear method of allocation concealment might present problems in terms of the overall quality of evidence. Investigators must make every effort to improve research quality.

For some of the results described in the review (hypothermia, weight gain, breastfeeding, and length of hospital stay), evidence shows high levels of statistical heterogeneity. Some of this heterogeneity may have occurred as a result of clinical heterogeneity, for example, different definitions of hypothermia were used, or women may not have been asked about breastfeeding in the same way in different trials. Results of meta-analysis with substantial heterogeneity should be interpreted cautiously.

Potential biases in the review process

We attempted to reduce bias in the review process wherever possible. Two review authors independently assessed the risk of bias and findings of included studies. We tried to contact authors of studies with missing data but obtained limited response. Despite differences in the timing of outcome measurements among studies, we proceeded with meta-analyses for several outcomes, as intervention effects were consistent among studies, although to varying degrees. Only one study reported about 50% of outcomes evaluated in the review, precluding convincing conclusions on the effect of KMC on such outcomes.

The beneficial effects of KMC on mortality at discharge or at 40 to 41 weeks' postmenstrual age and at latest follow-up, severe infection/sepsis, and nosocomial infection found in our meta-analyses are enhanced by the impressive statistical homogeneity observed among trials (I2 = 0% to 7%).

To date, only one study (Charpak 1997) reported neurodevelopmental results at one year of corrected age. Longer-term assessments of neurodevelopmental outcomes have not been published yet, and some caution should perhaps be exercised in applying these findings at 12 months' corrected age, because it has been suggested that assessments done at a relatively young age may be insufficiently predictive of longer-term neurodevelopmental outcomes, particularly with regard to cognitive functioning (Roberts 2010).

Agreements and disagreements with other studies or reviews

Previous versions of this review

Our assessment of the evidence was similar to that provided in the previous version of this review (Conde-Agudelo 2014), which concluded that "the evidence from this updated review supports the use of KMC in LBW infants as an alternative to conventional neonatal care mainly in resource-limited settings." In the current version of this review, we included three additional trials and results of infant neurobehavior at 40 to 44 weeks' postmenstrual age of a previously included study. Notwithstanding, the conclusions of this updated review have not changed in relation to those of the previous version of the review. It should be noted that the first two versions of this review (Conde-Agudelo 2000; Conde-Agudelo 2003), including only three trials (n = 1362 infants), had concluded that "although KMC appears to reduce severe infant morbidity without any serious deleterious effect reported, there is still insufficient evidence to recommend its routine use in LBW infants." In these earlier versions, biases related to blinding of participants, personnel and outcome assessors were assessed within a single domain. In the current version , we assessed blinding of participants and personnel in a domain that was separate from bias related to blinding of outcome assessment, as recommended in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011).

The findings of the current updated version of this review allow us to reassert that evidence is sufficient for review authors to recommend the use of KMC in stabilized LBW infants.

Other systematic reviews on KMC

Lawn 2010 performed a systematic review and meta-analysis to estimate the effect of KMC on neonatal mortality due to direct complications of preterm birth. This review included observational studies and excluded RCTs that initiated KMC after the first week of life. In the meta-analysis of RCTs, which included three studies (Charpak 1997; Suman 2008; Worku 2005) that provided data on neonatal specific mortality, KMC was associated with a reduction in neonatal death among infants < 2000 g (risk ratio [RR] 0.49, 95% CI 0.29 to 0.82; I2 = 0%; 988 infants). In the meta-analysis of three observational studies, KMC was associated with decreased risk of neonatal death in infants < 2000 g (RR 0.68, 95% CI 0.58 to 0.79; I2 = 54%; 8151 infants). Another meta-analysis, which included five RCTs, showed that KMC reduced significantly the risk of severe morbidity (RR 0.34, 95% CI 0.17 to 0.65; I2 = 70%; 1520 infants).

Boundy 2016 conducted a systematic review and meta-analysis of RCTs and observational studies to assess the effect of KMC on neonatal outcomes among infants of any birthweight or gestational age. Studies with fewer than 10 participants, lack of a comparison group without KMC, and not reporting a quantitative association were excluded. Among LBW infants < 2000 g, KMC was associated with a significant decrease in the risk of mortality at latest follow-up (RR 0.64, 95% CI 0.46 to 0.89; I2 = 72%; 15 studies [9 RCTs and 6 observational studies]).

The results of our review suggest that KMC reduces the risk of mortality at discharge or at 40 to 41 weeks' postmenstrual age and at latest follow-up. Our estimated effects were similar to those of Boundy 2016 and were smaller than those of Lawn 2010. Differences between the findings of this updated review and those of Lawn 2010 and Boundy 2016 are explained by inclusion of only RCTs and of a greater number of studies in our review.

Authors' conclusions

Implications for practice

Results of this updated review indicate that, currently, evidence is sufficient to support the use of kangaroo mother care (KMC) in stabilized low birthweight (LBW) infants as an alternative to conventional neonatal care in resource-limited settings. Although current evidence is mainly limited to the use of KMC in low/middle-income countries, emerging evidence suggests that use of KMC could improve breastfeeding rates in high-income countries. Subgroup analyses suggest that both continuous KMC and intermittent KMC are beneficial for stabilized LBW infants. Given that the control group in studies evaluating continuous KMC was kept in incubators or radiant warmers, the potential beneficial effects of KMC on morbidity and mortality of LBW infants would be expected to be greatest in settings in which conventional neonatal care is unavailable.

To date, early-onset continuous KMC in unstabilized or relatively stabilized LBW infants cannot be recommended on the basis of evidence provided by two small trials.

Implications for research

Several areas require further study in light of the results of this review.

  • Methodologically rigorous trials are needed to further explore the effectiveness of early-onset continuous KMC in unstabilized or relatively stabilized LBW infants in low-income settings. Studies should provide detailed information on inclusion and exclusion criteria, methods used to generate and conceal the allocation sequence, measures used to blind outcome assessors to allocation of participants, completeness of outcome data for each main outcome (attritions and exclusions), definition of infant stabilization, infant age at initiation of KMC, and frequency, daily duration, and total duration of the intervention, and investigators should report adequately all prespecified outcomes in the study protocol. We are aware that a planned RCT (OMWaNA study) will assess the effect of early KMC among unstable infants weighing ≤ 2000g in eastern Uganda.

  • Only five RCTs, including a total of 256 infants, which were conducted in developed countries and reported clinical outcome measures, met minimal inclusion criteria (Blaymore Bier 1996; Neu 2010; Roberts 2000; Rojas 2003; Whitelaw 1988). Therefore, randomized trials with an adequate sample size are clearly needed to evaluate the use of continuous or intermittent KMC in high-income settings and to report results mainly on infant morbidity.

  • Although some data on long-term neurodevelopmental and neurosensory outcomes are available, continuing follow-up and additional data for randomized children are justified, as more subtle differences may become apparent in later childhood (Roberts 2010).

  • Additional studies are needed to investigate effects of early-onset KMC on breastfeeding.

  • Well-designed economic evaluations are needed to assess the cost-effectiveness of KMC in low-, middle-, and high-income settings.

  • Exploration of mother-infant attachment should be pursued in future trials, as this element has been inconsistently evaluated across studies.

  • Additional trials in different settings ensuring baseline comparability of mortality, adequate KMC implementation, and birthweight assessment are required to clarify the effect of community-based KMC on LBW neonatal mortality before community-based KMC programs are implemented and before community-based KMC is included in essential newborn care.

Acknowledgements

We thank the following trial authors, who provided additional information on request: Drs Charpak, Sloan, Ludington-Hoe, Neu, Suman, Miltersteiner, and Murki.

Data and analyses

Download statistical data

Comparison 1. Kangaroo mother care versus conventional neonatal care
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Mortality at discharge or at 40 to 41 weeks' postmenstrual age8 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
1.1 All studies81736Risk Ratio (M-H, Fixed, 95% CI)0.60 [0.39, 0.92]
1.2 Intermittent KMC5619Risk Ratio (M-H, Fixed, 95% CI)0.59 [0.19, 1.81]
1.3 Continuous KMC31117Risk Ratio (M-H, Fixed, 95% CI)0.60 [0.38, 0.96]
1.4 Duration of KMC < 2 hours/d2188Risk Ratio (M-H, Fixed, 95% CI)1.32 [0.22, 7.73]
1.5 Duration of KMC between 6 and 15 hours/d3431Risk Ratio (M-H, Fixed, 95% CI)0.34 [0.07, 1.64]
1.6 Duration of KMC ≥ 20 hours/d31117Risk Ratio (M-H, Fixed, 95% CI)0.60 [0.38, 0.96]
1.7 Infant age ≤ 10 days at initiation of KMC51412Risk Ratio (M-H, Fixed, 95% CI)0.56 [0.36, 0.88]
1.8 Infant age > 10 days at initiation of KMC3324Risk Ratio (M-H, Fixed, 95% CI)1.32 [0.22, 7.73]
1.9 Low/middle-income countries71676Risk Ratio (M-H, Fixed, 95% CI)0.57 [0.37, 0.89]
1.10 High-income countries160Risk Ratio (M-H, Fixed, 95% CI)1.64 [0.16, 17.09]
1.11 infant entered into trial before stabilization1123Risk Ratio (M-H, Fixed, 95% CI)0.57 [0.33, 1.00]
1.12 infant entered into trial after stabilization71613Risk Ratio (M-H, Fixed, 95% CI)0.63 [0.32, 1.23]
2 Mortality at 6 months of age or 6 months' follow-up2354Risk Ratio (M-H, Fixed, 95% CI)0.99 [0.48, 2.02]
2.1 Intermittent171Risk Ratio (M-H, Fixed, 95% CI)1.03 [0.15, 6.90]
2.2 Continuous1283Risk Ratio (M-H, Fixed, 95% CI)0.98 [0.46, 2.12]
3 Mortality at 12 months' corrected age1693Risk Ratio (M-H, Fixed, 95% CI)0.57 [0.27, 1.17]
3.1 Intermittent00Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
3.2 Continuous1693Risk Ratio (M-H, Fixed, 95% CI)0.57 [0.27, 1.17]
4 Mortality at latest follow-up12 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
4.1 All studies122293Risk Ratio (M-H, Fixed, 95% CI)0.67 [0.48, 0.95]
4.2 Intermittent KMC8909Risk Ratio (M-H, Fixed, 95% CI)0.68 [0.26, 1.77]
4.3 Continuous KMC41384Risk Ratio (M-H, Fixed, 95% CI)0.67 [0.46, 0.98]
4.4 Duration of KMC < 2 hours/d3259Risk Ratio (M-H, Fixed, 95% CI)1.18 [0.32, 4.30]
4.5 Duration of KMC between 6 and 15 hours/d5650Risk Ratio (M-H, Fixed, 95% CI)0.34 [0.07, 1.64]
4.6 Duration of KMC ≥ 20 hours/d41384Risk Ratio (M-H, Fixed, 95% CI)0.67 [0.46, 0.98]
4.7 Infant age ≤ 10 days at initiation of KMC61489Risk Ratio (M-H, Fixed, 95% CI)0.56 [0.37, 0.85]
4.8 Infant age > 10 days at initiation of KMC5678Risk Ratio (M-H, Fixed, 95% CI)1.03 [0.53, 2.00]
4.9 Low/middle-income countries102162Risk Ratio (M-H, Fixed, 95% CI)0.65 [0.45, 0.93]
4.10 High-income countries2131Risk Ratio (M-H, Fixed, 95% CI)1.25 [0.29, 5.42]
4.11 Infant entered into trial before stabilization1123Risk Ratio (M-H, Fixed, 95% CI)0.57 [0.33, 1.00]
4.12 Infant entered into trial after stabilization112170Risk Ratio (M-H, Fixed, 95% CI)0.73 [0.47, 1.13]
5 Severe infection/sepsis at latest follow-up - stabilized infants81463Risk Ratio (M-H, Fixed, 95% CI)0.50 [0.36, 0.69]
5.1 Intermittent7800Risk Ratio (M-H, Fixed, 95% CI)0.38 [0.24, 0.60]
5.2 Continuous1663Risk Ratio (M-H, Fixed, 95% CI)0.69 [0.43, 1.12]
6 Severe illness at 6 months' follow-up - stabilized infants1283Risk Ratio (M-H, Fixed, 95% CI)0.30 [0.14, 0.67]
6.1 intermittent00Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
6.2 Continuous1283Risk Ratio (M-H, Fixed, 95% CI)0.30 [0.14, 0.67]
7 Nosocomial infection/sepsis at discharge or at 40 to 41 weeks' postmenstrual age - stabilized infants51239Risk Ratio (M-H, Fixed, 95% CI)0.35 [0.22, 0.54]
7.1 Intermittent4576Risk Ratio (M-H, Fixed, 95% CI)0.27 [0.15, 0.50]
7.2 Continuous1663Risk Ratio (M-H, Fixed, 95% CI)0.49 [0.25, 0.93]
8 Mild/moderate infection or illness at latest follow-up - stabilized infants41266Risk Ratio (M-H, Random, 95% CI)1.28 [0.87, 1.88]
8.1 Intermittent2320Risk Ratio (M-H, Random, 95% CI)1.52 [0.43, 5.38]
8.2 Continuous2946Risk Ratio (M-H, Random, 95% CI)1.42 [0.53, 3.79]
9 Lower respiratory tract disease at 6 months' follow-up - stabilized infants1283Risk Ratio (M-H, Fixed, 95% CI)0.37 [0.15, 0.89]
9.1 Intermittent00Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
9.2 Continuous1283Risk Ratio (M-H, Fixed, 95% CI)0.37 [0.15, 0.89]
10 Diarrhea at 6 months' follow-up - stabilized infants1283Risk Ratio (M-H, Fixed, 95% CI)0.65 [0.35, 1.20]
10.1 Intermittent00Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
10.2 Continuous1283Risk Ratio (M-H, Fixed, 95% CI)0.65 [0.35, 1.20]
11 Hypothermia at discharge or at 40 to 41 weeks’ postmenstrual age - stabilized infants9989Risk Ratio (M-H, Random, 95% CI)0.28 [0.16, 0.49]
11.1 Intermittent9989Risk Ratio (M-H, Random, 95% CI)0.28 [0.16, 0.49]
11.2 Continuous00Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]
12 Hyperthermia at discharge or at 40 to 41 weeks' postmenstrual age - stabilized infants4448Risk Ratio (M-H, Fixed, 95% CI)0.79 [0.59, 1.05]
12.1 Intermittent4448Risk Ratio (M-H, Fixed, 95% CI)0.79 [0.59, 1.05]
12.2 Continuous00Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
13 Length of hospital stay (days) - stabilized infants111057Mean Difference (IV, Random, 95% CI)-1.61 [-3.41, 0.18]
13.1 Intermittent111057Mean Difference (IV, Random, 95% CI)-1.61 [-3.41, 0.18]
13.2 Continuous00Mean Difference (IV, Random, 95% CI)0.0 [0.0, 0.0]
14 Re-admission to hospital at latest follow-up - stabilized infants2946Risk Ratio (M-H, Fixed, 95% CI)0.60 [0.34, 1.06]
14.1 Intermittent00Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
14.2 Continuous2946Risk Ratio (M-H, Fixed, 95% CI)0.60 [0.34, 1.06]
15 Weight at discharge or at 40 to 41 weeks' postmenstrual age (g) - stabilized infants51233Mean Difference (IV, Fixed, 95% CI)16.07 [-20.54, 52.68]
15.1 Intermittent3285Mean Difference (IV, Fixed, 95% CI)41.84 [-19.19, 102.87]
15.2 Continuous2948Mean Difference (IV, Fixed, 95% CI)1.59 [-44.16, 47.34]
16 Weight at 6 months' corrected age (g) - stabilized infants1591Mean Difference (IV, Fixed, 95% CI)78.19 [-52.26, 208.64]
16.1 Intermittent00Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]
16.2 Continuous1591Mean Difference (IV, Fixed, 95% CI)78.19 [-52.26, 208.64]
17 Weight at 12 months' corrected age (g) - stabilized infants1596Mean Difference (IV, Fixed, 95% CI)31.46 [-135.08, 198.00]
17.1 Intermittent00Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]
17.2 Continuous1596Mean Difference (IV, Fixed, 95% CI)31.46 [-135.08, 198.00]
18 Weight gain at latest follow-up (g/d) - stabilized infants111198Mean Difference (IV, Random, 95% CI)4.08 [2.30, 5.86]
18.1 Intermittent10913Mean Difference (IV, Random, 95% CI)4.13 [2.19, 6.07]
18.2 Continuous1285Mean Difference (IV, Random, 95% CI)3.60 [0.78, 6.42]
19 Length at discharge or at 40 to 41 weeks' postmenstrual age (cm) - stabilized infants3856Mean Difference (IV, Random, 95% CI)-0.11 [-0.69, 0.48]
19.1 Intermittent2193Mean Difference (IV, Random, 95% CI)-0.24 [-1.51, 1.04]
19.2 Continuous1663Mean Difference (IV, Random, 95% CI)0.0 [-0.36, 0.36]
20 Length at 6 months' corrected age (cm) - stabilized infants1590Mean Difference (IV, Fixed, 95% CI)0.23 [-0.18, 0.64]
20.1 Intermittent00Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]
20.2 Continuous1590Mean Difference (IV, Fixed, 95% CI)0.23 [-0.18, 0.64]
21 Length at 12 months' corrected age (cm) - stabilized infants1586Mean Difference (IV, Fixed, 95% CI)0.31 [-0.17, 0.79]
21.1 Intermittent00Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]
21.2 Continuous1586Mean Difference (IV, Fixed, 95% CI)0.31 [-0.17, 0.79]
22 Length gain at latest follow-up (cm/wk) - stabilized infants3377Mean Difference (IV, Random, 95% CI)0.21 [0.03, 0.38]
22.1 Intermittent3377Mean Difference (IV, Random, 95% CI)0.21 [0.03, 0.38]
22.2 Continuous00Mean Difference (IV, Random, 95% CI)0.0 [0.0, 0.0]
23 Head circumference at discharge or at 40 to 41 weeks' postmenstrual age (cm) - stabilized infants3856Mean Difference (IV, Random, 95% CI)0.17 [-0.33, 0.66]
23.1 Intermittent2193Mean Difference (IV, Random, 95% CI)0.24 [-0.84, 1.31]
23.2 Continuous1663Mean Difference (IV, Random, 95% CI)0.10 [-0.14, 0.34]
24 Head circumference at 6 months' corrected age (cm) - stabilized infants1592Mean Difference (IV, Fixed, 95% CI)0.34 [0.11, 0.57]
24.1 Intermittent00Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]
24.2 Continuous1592Mean Difference (IV, Fixed, 95% CI)0.34 [0.11, 0.57]
25 Head circumference at 12 months' corrected age (cm) - stabilized infants1597Mean Difference (IV, Fixed, 95% CI)0.39 [-0.00, 0.78]
25.1 Intermittent00Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]
25.2 Continuous1597Mean Difference (IV, Fixed, 95% CI)0.39 [-0.00, 0.78]
26 Head circumference gain at latest follow-up (cm/wk) - stabilized infants4495Mean Difference (IV, Random, 95% CI)0.14 [0.06, 0.22]
26.1 Intermittent4495Mean Difference (IV, Random, 95% CI)0.14 [0.06, 0.22]
26.2 Continuous00Mean Difference (IV, Random, 95% CI)0.0 [0.0, 0.0]
27 Psychomotor development (Griffith quotients) at 12 months' corrected age1 Mean Difference (IV, Fixed, 95% CI)Subtotals only
27.1 Locomotion1579Mean Difference (IV, Fixed, 95% CI)2.25 [-0.45, 4.95]
27.2 Personal, social1579Mean Difference (IV, Fixed, 95% CI)0.97 [-1.27, 3.21]
27.3 Hand-eye coordination1579Mean Difference (IV, Fixed, 95% CI)0.57 [-1.25, 2.39]
27.4 Audition, language1579Mean Difference (IV, Fixed, 95% CI)1.29 [-0.98, 3.56]
27.5 Execution1579Mean Difference (IV, Fixed, 95% CI)0.30 [-1.50, 2.10]
27.6 All criteria1579Mean Difference (IV, Fixed, 95% CI)1.05 [-0.75, 2.85]
28 Cerebral palsy at 12 months' corrected age1588Risk Ratio (M-H, Fixed, 95% CI)0.65 [0.21, 2.02]
29 Deafness at 12 months' corrected age1588Risk Ratio (M-H, Fixed, 95% CI)0.30 [0.03, 2.90]
30 Visual impairment at 12 months' corrected age1588Risk Ratio (M-H, Fixed, 95% CI)0.91 [0.53, 1.56]
31 Exclusive breastfeeding at discharge or at 40 to 41 weeks' postmenstrual age - stabilized infants61453Risk Ratio (M-H, Fixed, 95% CI)1.16 [1.07, 1.25]
31.1 Intermittent4511Risk Ratio (M-H, Fixed, 95% CI)1.22 [1.11, 1.35]
31.2 Continuous2942Risk Ratio (M-H, Fixed, 95% CI)1.11 [1.00, 1.24]
32 Exclusive breastfeeding at 1 to 3 months' follow-up - stabilized infants5600Risk Ratio (M-H, Random, 95% CI)1.20 [1.01, 1.43]
32.1 Intermittent3221Risk Ratio (M-H, Random, 95% CI)1.36 [1.12, 1.65]
32.2 Continuous2379Risk Ratio (M-H, Random, 95% CI)1.03 [0.96, 1.10]
33 Exclusive breastfeeding at 6 to 12 months' follow-up - stabilized infants3810Risk Ratio (M-H, Fixed, 95% CI)1.29 [0.95, 1.76]
33.1 Intermittent175Risk Ratio (M-H, Fixed, 95% CI)1.52 [1.10, 2.10]
33.2 Continuous2735Risk Ratio (M-H, Fixed, 95% CI)1.10 [0.66, 1.86]
34 Any breastfeeding at discharge or at 40 to 41 weeks' postmenstrual age - stabilized infants101696Risk Ratio (M-H, Random, 95% CI)1.20 [1.07, 1.34]
34.1 Intermittent8754Risk Ratio (M-H, Random, 95% CI)1.23 [1.07, 1.41]
34.2 Continuous2942Risk Ratio (M-H, Random, 95% CI)1.14 [0.93, 1.40]
35 Any breastfeeding at 1 to 2 months' follow-up - stabilized infants6538Risk Ratio (M-H, Random, 95% CI)1.33 [1.00, 1.78]
35.1 Intermittent4159Risk Ratio (M-H, Random, 95% CI)1.89 [1.30, 2.75]
35.2 Continuous2379Risk Ratio (M-H, Random, 95% CI)1.03 [0.96, 1.10]
36 Any breastfeeding at 3 months' follow-up - stabilized infants5924Risk Ratio (M-H, Fixed, 95% CI)1.14 [1.06, 1.23]
36.1 Intermittent4261Risk Ratio (M-H, Fixed, 95% CI)1.35 [1.15, 1.59]
36.2 Continuous1663Risk Ratio (M-H, Fixed, 95% CI)1.08 [1.00, 1.17]
37 Any breastfeeding at 1 to 3 months' follow-up - stabilized infants91394Risk Ratio (M-H, Random, 95% CI)1.17 [1.05, 1.31]
37.1 Intermittent6352Risk Ratio (M-H, Random, 95% CI)1.39 [1.18, 1.64]
37.2 Continuous31042Risk Ratio (M-H, Random, 95% CI)1.05 [1.00, 1.11]
38 Any breastfeeding at 6 months' follow-up - stabilized infants5952Risk Ratio (M-H, Fixed, 95% CI)1.12 [0.98, 1.29]
38.1 Intermittent3143Risk Ratio (M-H, Fixed, 95% CI)1.50 [1.08, 2.08]
38.2 Continuous2809Risk Ratio (M-H, Fixed, 95% CI)1.07 [0.92, 1.24]
39 Any breastfeeding at 12 months' follow-up - stabilized infants1589Risk Ratio (M-H, Fixed, 95% CI)0.89 [0.65, 1.21]
39.1 Intermittent00Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
39.2 Continuous1589Risk Ratio (M-H, Fixed, 95% CI)0.89 [0.65, 1.21]
40 Onset of breastfeeding (days) - stabilized infants2295Mean Difference (IV, Random, 95% CI)0.03 [-1.64, 1.70]
40.1 Intermittent2295Mean Difference (IV, Random, 95% CI)0.03 [-1.64, 1.70]
40.2 Continuous00Mean Difference (IV, Random, 95% CI)0.0 [0.0, 0.0]
41 Parental and familial satisfaction (continuous KMC)1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
41.1 Mother satisfied with method1269Risk Ratio (M-H, Fixed, 95% CI)1.17 [1.05, 1.30]
41.2 Father satisfied with method1269Risk Ratio (M-H, Fixed, 95% CI)1.02 [0.91, 1.14]
41.3 Family satisfied with method1269Risk Ratio (M-H, Fixed, 95% CI)0.97 [0.83, 1.13]
42 Mother-infant attachment: mother's feelings and perceptions according to interval between birth and start of intervention, and infant admission to NICU1 Mean Difference (IV, Fixed, 95% CI)Subtotals only
42.1 Sense of competence - interval of 1 to 2 days1170Mean Difference (IV, Fixed, 95% CI)0.41 [0.14, 0.68]
42.2 Sense of competence - interval of 3 to 14 days1177Mean Difference (IV, Fixed, 95% CI)0.25 [-0.08, 0.58]
42.3 Sense of competence - interval > 14 days1141Mean Difference (IV, Fixed, 95% CI)0.21 [-0.17, 0.59]
42.4 Sense of competence - infant admitted to NICU182Mean Difference (IV, Fixed, 95% CI)0.54 [0.07, 1.01]
42.5 Sense of competence - infant not admitted to NICU1406Mean Difference (IV, Fixed, 95% CI)0.24 [0.05, 0.43]
42.6 Worry and stress - interval of 1 to 2 days1170Mean Difference (IV, Fixed, 95% CI)0.31 [0.04, 0.58]
42.7 Worry and stress - interval of 3 to 14 days1177Mean Difference (IV, Fixed, 95% CI)0.09 [-0.20, 0.38]
42.8 Worry and stress - interval > 14 days1141Mean Difference (IV, Fixed, 95% CI)-0.29 [-0.70, 0.12]
42.9 Worry and stress - infant admitted to NICU182Mean Difference (IV, Fixed, 95% CI)-0.1 [-0.60, 0.40]
42.10 Worry and stress - infant not admitted to NICU1406Mean Difference (IV, Fixed, 95% CI)0.12 [-0.06, 0.30]
42.11 Social support - interval of 1 to 2 days1170Mean Difference (IV, Fixed, 95% CI)-0.06 [-0.35, 0.23]
42.12 Social support - interval of 3 to 14 days1177Mean Difference (IV, Fixed, 95% CI)-0.06 [-0.34, 0.22]
42.13 Social support - interval > 14 days1141Mean Difference (IV, Fixed, 95% CI)-0.47 [-0.84, -0.10]
42.14 Social support - infant admitted to NICU182Mean Difference (IV, Fixed, 95% CI)-0.05 [-0.52, 0.42]
42.15 Social support - infant not admitted to NICU1406Mean Difference (IV, Fixed, 95% CI)-0.2 [-0.39, -0.01]
43 Mother-infant attachment: mother's responses to the infant according to interval between birth and start of intervention, and infant admission to NICU1 Mean Difference (IV, Fixed, 95% CI)Subtotals only
43.1 Mother's sensitivity - interval of 1 to 2 days1170Mean Difference (IV, Fixed, 95% CI)0.02 [-0.02, 0.06]
43.2 Mother's sensitivity - interval of 3 to 14 days1177Mean Difference (IV, Fixed, 95% CI)-0.01 [-0.05, 0.03]
43.3 Mother's sensitivity - interval > 14 days1141Mean Difference (IV, Fixed, 95% CI)0.06 [0.01, 0.11]
43.4 Mother's sensitivity - infant admitted to NICU182Mean Difference (IV, Fixed, 95% CI)0.02 [-0.04, 0.08]
43.5 Mother's sensitivity - infant not admitted to NICU1406Mean Difference (IV, Fixed, 95% CI)0.02 [-0.00, 0.04]
43.6 Mother's response to child's distress - interval of 1 to 2 days1170Mean Difference (IV, Fixed, 95% CI)-0.03 [-0.08, 0.02]
43.7 Mother's response to child's distress - interval of 3 to 14 days1177Mean Difference (IV, Fixed, 95% CI)0.01 [-0.03, 0.05]
43.8 Mother's response to child's distress - interval > 14 days1141Mean Difference (IV, Fixed, 95% CI)0.01 [-0.04, 0.06]
43.9 Mother's response to child's distress - infant admitted to NICU182Mean Difference (IV, Fixed, 95% CI)0.05 [-0.01, 0.11]
43.10 Mother's response to child's distress - infant not admitted to NICU1406Mean Difference (IV, Fixed, 95% CI)-0.02 [-0.05, 0.01]
43.11 Mother's response to child's socioemotional growth fostering - interval of 1 to 2 days1170Mean Difference (IV, Fixed, 95% CI)0.01 [-0.04, 0.06]
43.12 Mother's response to child's socioemotional growth fostering - interval of 3 to 14 days1177Mean Difference (IV, Fixed, 95% CI)-0.02 [-0.06, 0.02]
43.13 Mother's response to child's socioemotional growth fostering - interval > 14 days1141Mean Difference (IV, Fixed, 95% CI)0.05 [-0.00, 0.10]
43.14 Mother's response to child's socioemotional growth fostering - infant admitted to NICU182Mean Difference (IV, Fixed, 95% CI)-0.05 [-0.12, 0.02]
43.15 Mother's response to child's socioemotional growth fostering - infant not admitted to NICU1406Mean Difference (IV, Fixed, 95% CI)0.02 [-0.01, 0.05]
43.16 Mother's response to child's cognitive growth fostering - interval of 1 to 2 days1170Mean Difference (IV, Fixed, 95% CI)0.02 [-0.04, 0.08]
43.17 Mother's response to child's cognitive growth fostering - interval of 3 to 14 days1177Mean Difference (IV, Fixed, 95% CI)-0.04 [-0.10, 0.02]
43.18 Mother's response to child's cognitive growth fostering - interval > 14 days1141Mean Difference (IV, Fixed, 95% CI)0.07 [0.00, 0.14]
43.19 Mother's response to child's cognitive growth fostering - infant admitted to NICU182Mean Difference (IV, Fixed, 95% CI)-0.07 [-0.17, 0.03]
43.20 Mother's response to child's cognitive growth fostering - infant not admitted to NICU1406Mean Difference (IV, Fixed, 95% CI)0.03 [-0.01, 0.07]
44 Mother-infant attachment: infant's responses to the mother according to interval between birth and start of intervention, and infant admission to NICU1 Mean Difference (IV, Fixed, 95% CI)Subtotals only
44.1 Clarity of cues - interval of 1 to 2 days1170Mean Difference (IV, Fixed, 95% CI)0.01 [-0.04, 0.06]
44.2 Clarity of cues - interval of 3 to 14 days1177Mean Difference (IV, Fixed, 95% CI)0.02 [-0.03, 0.07]
44.3 Clarity of cues - interval > 14 days1141Mean Difference (IV, Fixed, 95% CI)0.0 [-0.05, 0.05]
44.4 Clarity of cues - infant admitted to NICU182Mean Difference (IV, Fixed, 95% CI)-0.01 [-0.07, 0.05]
44.5 Clarity of cues - infant not admitted to NICU1406Mean Difference (IV, Fixed, 95% CI)0.02 [-0.01, 0.05]
44.6 Responsiveness - interval of 1 to 2 days1170Mean Difference (IV, Fixed, 95% CI)-0.02 [-0.06, 0.02]
44.7 Responsiveness - interval of 3 to 14 days1177Mean Difference (IV, Fixed, 95% CI)0.02 [-0.02, 0.06]
44.8 Responsiveness - interval > 14 days1141Mean Difference (IV, Fixed, 95% CI)0.05 [0.01, 0.09]
44.9 Responsiveness - infant admitted to NICU182Mean Difference (IV, Fixed, 95% CI)-0.01 [-0.07, 0.05]
44.10 Responsiveness - infant not admitted to NICU1406Mean Difference (IV, Fixed, 95% CI)0.02 [-0.01, 0.05]
45 Mother-infant attachment at 3 months' follow-up1100Mean Difference (IV, Fixed, 95% CI)6.24 [5.57, 6.91]
45.1 Total attachment score at 3 months' follow-up1100Mean Difference (IV, Fixed, 95% CI)6.24 [5.57, 6.91]
46 Mother-infant attachment: stress in NICU1 Mean Difference (IV, Fixed, 95% CI)Subtotals only
46.1 Nursery environment score130Mean Difference (IV, Fixed, 95% CI)0.10 [-0.51, 0.71]
46.2 Infant appearance score130Mean Difference (IV, Fixed, 95% CI)0.0 [-0.62, 0.62]
46.3 Relationship with the infant score130Mean Difference (IV, Fixed, 95% CI)1.00 [0.35, 1.65]
46.4 Staff behavior and communication score130Mean Difference (IV, Fixed, 95% CI)0.10 [-0.95, 1.15]
47 Mother-infant attachment: parenting skills130Mean Difference (IV, Fixed, 95% CI)-0.40 [-0.89, 0.09]
47.1 Total score at discharge130Mean Difference (IV, Fixed, 95% CI)-0.40 [-0.89, 0.09]
48 Mother-infant interaction at 6 months' follow-up1 Mean Difference (IV, Fixed, 95% CI)Subtotals only
48.1 Symmetrical co-regulation145Mean Difference (IV, Fixed, 95% CI)16.38 [13.61, 19.15]
48.2 Asymmetrical co-regulation145Mean Difference (IV, Fixed, 95% CI)-18.31 [-21.42, -15.20]
48.3 Unilateral regulation145Mean Difference (IV, Fixed, 95% CI)2.12 [-1.24, 5.48]
49 Infant behavior at 40 to 44 weeks’ postmenstrual age1 Mean Difference (IV, Fixed, 95% CI)Subtotals only
49.1 Attention155Mean Difference (IV, Fixed, 95% CI)0.29 [-0.40, 0.98]
49.2 Autonomic organization155Mean Difference (IV, Fixed, 95% CI)0.19 [-0.41, 0.79]
49.3 Motor155Mean Difference (IV, Fixed, 95% CI)0.30 [-0.22, 0.82]
49.4 Orientation155Mean Difference (IV, Fixed, 95% CI)-0.19 [-0.72, 0.34]
49.5 Autonomic155Mean Difference (IV, Fixed, 95% CI)0.11 [-0.89, 1.11]
49.6 State regulation155Mean Difference (IV, Fixed, 95% CI)-0.31 [-0.95, 0.33]
49.7 Robust crying155Mean Difference (IV, Fixed, 95% CI)-0.16 [-0.90, 0.58]
49.8 State stability155Mean Difference (IV, Fixed, 95% CI)0.32 [-0.93, 1.57]
50 Social and home environment1338Mean Difference (IV, Fixed, 95% CI)0.79 [0.74, 0.84]
50.1 HOME environment total score at 12 months' corrected age1338Mean Difference (IV, Fixed, 95% CI)0.79 [0.74, 0.84]
Analysis 1.1.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 1 Mortality at discharge or at 40 to 41 weeks' postmenstrual age.

Analysis 1.2.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 2 Mortality at 6 months of age or 6 months' follow-up.

Analysis 1.3.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 3 Mortality at 12 months' corrected age.

Analysis 1.4.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 4 Mortality at latest follow-up.

Analysis 1.5.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 5 Severe infection/sepsis at latest follow-up - stabilized infants.

Analysis 1.6.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 6 Severe illness at 6 months' follow-up - stabilized infants.

Analysis 1.7.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 7 Nosocomial infection/sepsis at discharge or at 40 to 41 weeks' postmenstrual age - stabilized infants.

Analysis 1.8.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 8 Mild/moderate infection or illness at latest follow-up - stabilized infants.

Analysis 1.9.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 9 Lower respiratory tract disease at 6 months' follow-up - stabilized infants.

Analysis 1.10.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 10 Diarrhea at 6 months' follow-up - stabilized infants.

Analysis 1.11.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 11 Hypothermia at discharge or at 40 to 41 weeks’ postmenstrual age - stabilized infants.

Analysis 1.12.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 12 Hyperthermia at discharge or at 40 to 41 weeks' postmenstrual age - stabilized infants.

Analysis 1.13.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 13 Length of hospital stay (days) - stabilized infants.

Analysis 1.14.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 14 Re-admission to hospital at latest follow-up - stabilized infants.

Analysis 1.15.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 15 Weight at discharge or at 40 to 41 weeks' postmenstrual age (g) - stabilized infants.

Analysis 1.16.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 16 Weight at 6 months' corrected age (g) - stabilized infants.

Analysis 1.17.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 17 Weight at 12 months' corrected age (g) - stabilized infants.

Analysis 1.18.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 18 Weight gain at latest follow-up (g/d) - stabilized infants.

Analysis 1.19.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 19 Length at discharge or at 40 to 41 weeks' postmenstrual age (cm) - stabilized infants.

Analysis 1.20.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 20 Length at 6 months' corrected age (cm) - stabilized infants.

Analysis 1.21.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 21 Length at 12 months' corrected age (cm) - stabilized infants.

Analysis 1.22.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 22 Length gain at latest follow-up (cm/wk) - stabilized infants.

Analysis 1.23.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 23 Head circumference at discharge or at 40 to 41 weeks' postmenstrual age (cm) - stabilized infants.

Analysis 1.24.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 24 Head circumference at 6 months' corrected age (cm) - stabilized infants.

Analysis 1.25.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 25 Head circumference at 12 months' corrected age (cm) - stabilized infants.

Analysis 1.26.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 26 Head circumference gain at latest follow-up (cm/wk) - stabilized infants.

Analysis 1.27.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 27 Psychomotor development (Griffith quotients) at 12 months' corrected age.

Analysis 1.28.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 28 Cerebral palsy at 12 months' corrected age.

Analysis 1.29.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 29 Deafness at 12 months' corrected age.

Analysis 1.30.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 30 Visual impairment at 12 months' corrected age.

Analysis 1.31.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 31 Exclusive breastfeeding at discharge or at 40 to 41 weeks' postmenstrual age - stabilized infants.

Analysis 1.32.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 32 Exclusive breastfeeding at 1 to 3 months' follow-up - stabilized infants.

Analysis 1.33.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 33 Exclusive breastfeeding at 6 to 12 months' follow-up - stabilized infants.

Analysis 1.34.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 34 Any breastfeeding at discharge or at 40 to 41 weeks' postmenstrual age - stabilized infants.

Analysis 1.35.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 35 Any breastfeeding at 1 to 2 months' follow-up - stabilized infants.

Analysis 1.36.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 36 Any breastfeeding at 3 months' follow-up - stabilized infants.

Analysis 1.37.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 37 Any breastfeeding at 1 to 3 months' follow-up - stabilized infants.

Analysis 1.38.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 38 Any breastfeeding at 6 months' follow-up - stabilized infants.

Analysis 1.39.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 39 Any breastfeeding at 12 months' follow-up - stabilized infants.

Analysis 1.40.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 40 Onset of breastfeeding (days) - stabilized infants.

Analysis 1.41.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 41 Parental and familial satisfaction (continuous KMC).

Analysis 1.42.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 42 Mother-infant attachment: mother's feelings and perceptions according to interval between birth and start of intervention, and infant admission to NICU.

Analysis 1.43.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 43 Mother-infant attachment: mother's responses to the infant according to interval between birth and start of intervention, and infant admission to NICU.

Analysis 1.44.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 44 Mother-infant attachment: infant's responses to the mother according to interval between birth and start of intervention, and infant admission to NICU.

Analysis 1.45.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 45 Mother-infant attachment at 3 months' follow-up.

Analysis 1.46.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 46 Mother-infant attachment: stress in NICU.

Analysis 1.47.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 47 Mother-infant attachment: parenting skills.

Analysis 1.48.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 48 Mother-infant interaction at 6 months' follow-up.

Analysis 1.49.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 49 Infant behavior at 40 to 44 weeks’ postmenstrual age.

Analysis 1.50.

Comparison 1 Kangaroo mother care versus conventional neonatal care, Outcome 50 Social and home environment.

Comparison 2. Early versus late kangaroo mother care in relatively stable LBW infants
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Mortality at 4 weeks of age173Risk Ratio (M-H, Fixed, 95% CI)1.95 [0.18, 20.53]
2 Morbidity at 4 weeks of age173Risk Ratio (M-H, Fixed, 95% CI)0.49 [0.18, 1.28]
3 Severe infection at 4 weeks of age173Risk Ratio (M-H, Fixed, 95% CI)0.42 [0.12, 1.49]
4 Re-admission to hospital at 4 weeks of age173Risk Ratio (M-H, Fixed, 95% CI)1.95 [0.18, 20.53]
5 Hypothermia173Risk Ratio (M-H, Fixed, 95% CI)0.58 [0.15, 2.27]
6 Hyperthermia173Risk Ratio (M-H, Fixed, 95% CI)1.05 [0.56, 1.99]
7 Weight gain (grams)1 Mean Difference (IV, Fixed, 95% CI)Subtotals only
7.1 At 24 hours post birth173Mean Difference (IV, Fixed, 95% CI)39.16 [11.11, 67.21]
7.2 At 48 hours post birth173Mean Difference (IV, Fixed, 95% CI)43.3 [5.49, 81.11]
7.3 At 2 weeks of age173Mean Difference (IV, Fixed, 95% CI)12.14 [-83.18, 107.46]
7.4 At 4 weeks of age173Mean Difference (IV, Fixed, 95% CI)58.85 [-116.93, 234.63]
8 Exclusive breastfeeding1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
8.1 At 24 hours of age173Risk Ratio (M-H, Fixed, 95% CI)1.02 [0.67, 1.57]
8.2 At 2 weeks of age171Risk Ratio (M-H, Fixed, 95% CI)1.00 [0.89, 1.12]
8.3 At 4 weeks of age167Risk Ratio (M-H, Fixed, 95% CI)0.94 [0.85, 1.04]
8.4 At 6 months of age155Risk Ratio (M-H, Fixed, 95% CI)2.69 [0.99, 7.31]
9 Length of hospital stay (days)173Mean Difference (IV, Fixed, 95% CI)-0.90 [-1.24, -0.56]
10 Mortality at 6 months of age172Risk Ratio (M-H, Fixed, 95% CI)1.0 [0.15, 6.72]
11 Re-admission to hospital at 6 to 12 months of age172Risk Ratio (M-H, Fixed, 95% CI)1.0 [0.32, 3.16]
12 Stunting at 6 to 12 months of age155Risk Ratio (M-H, Fixed, 95% CI)0.83 [0.46, 1.48]
13 Severe stunting at 6 to 12 months of age155Risk Ratio (M-H, Fixed, 95% CI)0.67 [0.17, 2.73]
14 Wasting at 6 to 12 months of age155Risk Ratio (M-H, Fixed, 95% CI)0.1 [0.01, 1.77]
15 Severe wasting at 6 to 12 months of age155Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
16 Underweight at 6 to 12 months of age155Risk Ratio (M-H, Fixed, 95% CI)0.49 [0.21, 1.14]
17 Severe underweight at 6 to 12 months of age155Risk Ratio (M-H, Fixed, 95% CI)0.22 [0.03, 1.88]
Analysis 2.1.

Comparison 2 Early versus late kangaroo mother care in relatively stable LBW infants, Outcome 1 Mortality at 4 weeks of age.

Analysis 2.2.

Comparison 2 Early versus late kangaroo mother care in relatively stable LBW infants, Outcome 2 Morbidity at 4 weeks of age.

Analysis 2.3.

Comparison 2 Early versus late kangaroo mother care in relatively stable LBW infants, Outcome 3 Severe infection at 4 weeks of age.

Analysis 2.4.

Comparison 2 Early versus late kangaroo mother care in relatively stable LBW infants, Outcome 4 Re-admission to hospital at 4 weeks of age.

Analysis 2.5.

Comparison 2 Early versus late kangaroo mother care in relatively stable LBW infants, Outcome 5 Hypothermia.

Analysis 2.6.

Comparison 2 Early versus late kangaroo mother care in relatively stable LBW infants, Outcome 6 Hyperthermia.

Analysis 2.7.

Comparison 2 Early versus late kangaroo mother care in relatively stable LBW infants, Outcome 7 Weight gain (grams).

Analysis 2.8.

Comparison 2 Early versus late kangaroo mother care in relatively stable LBW infants, Outcome 8 Exclusive breastfeeding.

Analysis 2.9.

Comparison 2 Early versus late kangaroo mother care in relatively stable LBW infants, Outcome 9 Length of hospital stay (days).

Analysis 2.10.

Comparison 2 Early versus late kangaroo mother care in relatively stable LBW infants, Outcome 10 Mortality at 6 months of age.

Analysis 2.11.

Comparison 2 Early versus late kangaroo mother care in relatively stable LBW infants, Outcome 11 Re-admission to hospital at 6 to 12 months of age.

Analysis 2.12.

Comparison 2 Early versus late kangaroo mother care in relatively stable LBW infants, Outcome 12 Stunting at 6 to 12 months of age.

Analysis 2.13.

Comparison 2 Early versus late kangaroo mother care in relatively stable LBW infants, Outcome 13 Severe stunting at 6 to 12 months of age.

Analysis 2.14.

Comparison 2 Early versus late kangaroo mother care in relatively stable LBW infants, Outcome 14 Wasting at 6 to 12 months of age.

Analysis 2.15.

Comparison 2 Early versus late kangaroo mother care in relatively stable LBW infants, Outcome 15 Severe wasting at 6 to 12 months of age.

Analysis 2.16.

Comparison 2 Early versus late kangaroo mother care in relatively stable LBW infants, Outcome 16 Underweight at 6 to 12 months of age.

Analysis 2.17.

Comparison 2 Early versus late kangaroo mother care in relatively stable LBW infants, Outcome 17 Severe underweight at 6 to 12 months of age.

Appendices

Appendix 1. Search strategy for the 2014 update

Electronic searches
The standard search strategy for the Cochrane Neonatal review Group was used.This included searches of MEDLINE, EMBASE, LILACS, POPLINE, and CINAHL databases (all from inception to March 31, 2014), and the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 3, 2014) using a combination of keywords and text words related to KMC or SSC and LBW or preterm infants. To ensure maximum sensitivity we placed no limits or filters on the searches.

INDEX TERMS
Text words
Kangaroo mother care; kangaroo mother method; kangaroo care; skin-to-skin contact, skin-to-skin care
Medical subject headings (MeSH)
*Infant, Low Birth Weight; *Infant Mortality; *Breast Feeding; *Mother-Child Relations; Infant, Newborn; Infant care [*Methods];
Length of Stay; Physical Stimulation; [*Methods]; Randomized Controlled Trials as Topic; Weight Gain

MeSH check words
Humans; Infant
We searched for ongoing trials most recently in September 2013 in the following databases using the terms “kangaroo care” and “skin-to-skin contact” :
• The metaRegister of Controlled Trials www.controlledtrials.com.
• The US National Institutes of Health ongoing trials register www.clinicaltrials.gov.
• The National Research Register (NRR) Archive http://www.nihr.ac.uk,
• The Australian and New Zealand Clinical Trials Registry www.anzctr.org.au.
• UMIN Clinical Trials Registry www.umin.ac.jp/ctr.
• The World Health Organization International Clinical Trials Registry platform www.who.int/trialsearch.

Searching other resources
Web page of the Kangaroo Foundation, International Network of Kangaroo Care, conference and symposia proceedings on KMC, reference lists of identified studies, textbooks, review articles, and Google scholar were also searched. In addition,we performed journal hand searching and contacted investigators involved in the field to locate unpublished studies. No language restrictions were applied. For studies with multiple publications, the data from the most complete report were used and supplemented if additional information appeared in other publications.

Appendix 2. Standard search methodology

PubMed: ((infant, newborn[MeSH] OR newborn OR neonate OR neonatal OR premature OR low birth weight OR VLBW OR LBW or infan* or neonat*) AND (randomized controlled trial [pt] OR controlled clinical trial [pt] OR Clinical Trial [ptyp] OR randomized [tiab] OR placebo [tiab] OR clinical trials as topic [mesh: noexp] OR randomly [tiab] OR trial [ti]) NOT (animals [mh] NOT humans [mh]))

Embase: (infant, newborn or newborn or neonate or neonatal or premature or very low birth weight or low birth weight or VLBW or LBW or Newborn or infan* or neonat*) AND (human not animal) AND (randomized controlled trial or controlled clinical trial or randomized or placebo or clinical trials as topic or randomly or trial or clinical trial)

CINAHL: (infant, newborn OR newborn OR neonate OR neonatal OR premature OR low birth weight OR VLBW OR LBW or Newborn or infan* or neonat*) AND (randomized controlled trial OR controlled clinical trial OR randomized OR placebo OR clinical trials as topic OR randomly OR trial OR PT clinical trial)

Cochrane Library: (infant or newborn or neonate or neonatal or premature or very low birth weight or low birth weight or VLBW or LBW)

What's new

DateEventDescription
6 February 2017AmendedAmended to add source of support.

History

DateEventDescription
4 August 2016New citation required but conclusions have not changedWe updated the search in June 2016 and found three new studies for inclusion (Acharya 2014; Kumbhojkar 2016; Nimbalkar 2014). The conclusions of the review are unchanged.
15 July 2016New search has been performedThis updates the review, "Kangaroo mother care to reduce morbidity and mortality in low birthweight infants," published in the Cochrane Database of Systematic Reviews (Conde-Agudelo 2014)
31 March 2014New search has been performedThis updates the review, "Kangaroo mother care to reduce morbidity and mortality in low birthweight infants," published in the Cochrane Database of Systematic Reviews (Conde-Agudelo 2011)
31 March 2014New citation required but conclusions have not changedA new search has been performed. In addition to the 16 studies included in the previous version of the review, we have included 2 new studies (Eka Pratiwi 2009; Ghavane 2012) and a report on additional outcomes of a previously included study (Nagai 2010). This updated review includes a new secondary outcome measure (hyperthermia at discharge or at 40 to 41 weeks' postmenstrual age) and additional data regarding the external validity of each included study, such as level of care, human resources used, criteria for infant discharge from the hospital, and scheme for follow-up of infants after discharge
26 September 2008AmendedConverted to new review format

Contributions of authors

The original review was carried out by Agustin Conde-Agudelo, Jose L. Diaz-Rossello, and Jose M. Belizán (Conde-Agudelo 2000). The same review authors updated the review in 2003 (Conde-Agudelo 2003) and 2011 (Conde-Agudelo 2011). Agustin Conde-Agudelo and Jose L. Diaz-Rossello updated the review in 2014 (Conde-Agudelo 2014). For this update, Dr Agustin Conde-Agudelo conducted all statistical analyses, wrote the first draft of the review, and revised subsequent drafts in response to feedback. Dr Jose L. Diaz-Rossello commented on the first draft of the updated review and contributed to the writing of the final draft.

Declarations of interest

None.

Sources of support

Internal sources

  • (AC-A) Perinatology Research Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development/National Institutes of Health/Department of Health and Human Services, Bethesda, MD, and Detroit, MI, and Department of Obstetrics and Gynecology, Wayne State University, Detroit, MI, USA.

  • (JLD-R) Departamento de Neonatología del Hospital de Clínicas, Universidad de la República, Montevideo, Uruguay.

External sources

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Department of Health and Human Services, USA.

    Editorial support of the Cochrane Neonatal Review Group has been funded with Federal funds from the Eunice Kennedy Shriver National Institute of Child Health and Human Development National Institutes of Health, Department of Health and Human Services, USA, under Contract No. HHSN275201100016C

  • National Institute for Health Research, UK.

    Editorial support for Cochrane Neonatal has been funded with funds from a UK National Institute of Health Research Grant (NIHR) Cochrane Programme Grant (13/89/12). The views expressed in this publication are those of the authors and not necessarily those of the NHS, the NIHR, or the UK Department of Health.

Differences between protocol and review

We have updated the Background and Methods sections. After the protocol was published, a new version of the Cochrane Handbook for Systematic Reviews of Interventions recommended a new approach to assess risk of bias. We changed our method of assessment to be consistent with these recommendations. We decided to group studies into continuous KMC and intermittent KMC after looking at variation in the interventions. We changed the labels for most primary and secondary outcomes and performed several new subgroup and sensitivity analyses. In the latest version of this review, we have included studies that evaluated KMC before stabilization, intermittent KMC, and early-onset KMC.

In this updated review, we have added the method and plan for 'Summary of findings' tables and GRADE (Grades of Recommendation, Assessment, Development and Evaluation Working Group) recommendations; these were not included in the original protocol.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Acharya 2014

MethodsRandomized controlled trial conducted in Dharan, Nepal
Participants

Number of infants: 126

Inclusion criteria: stable infants with birthweight < 2000 g admitted to the newborn nursery

Exclusion criteria: neonates critically ill requiring ventilatory or ionotropic support or radiant warmer, neonates with chromosomal and life-threatening congenital anomalies, neonates whose mothers were critically ill, and neonates whose mothers did not provide consent for enrollment into the study

Infant stabilization status at trial entry: stabilized

Infant age and weight at trial entry: Mean weight at recruitment was 1362 ± 240 g and 1452 ± 175 g for KMC and control infants, respectively. No data on infant age at recruitment

Interventions

KMC group: SSC between the mother's breasts in an upright position. Infants were dressed with diaper and a cap, and the mother's blouse covered the infant’s trunk and extremities but not the head. The duration of KMC was ≥ 6 hours per day in not more than 4 sittings, with each sitting lasting ≥ 1 hour. No data on total number of days that KMC was given after enrollment in the study (n = 63)

Control group: Infants were adequately clothed, covered, and kept with their mother. If infants did not maintain temperature, they were kept under a radiant warmer (n = 63)

Level of care: nursery of a tertiary care hospital

Human resources: doctors and nurses

Criteria for infant discharge from the hospital: unreported. However, it was mentioned that LBW infants were discharged when weight was > 1.600 g

Scheme for follow-up of infants after discharge: unreported

OutcomesGain in weight, length, and head circumference; hypothermia; apnea; hospital stay
Notes87% of LBW infants met eligibility criteria
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandom number table
Allocation concealment (selection bias)Unclear riskNo information provided
Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding of participants: no/unfeasible; blinding of clinical staff: no/unfeasible
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo information provided
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo infants apparently lost to follow-up
Selective reporting (reporting bias)Low riskAll outcomes stated in Methods section adequately reported or explained in Results
Other biasLow riskOther biases not identified

Ali 2009

MethodsRandomized controlled trial carried out in Aligarh, India
Participants

Number of infants: 114

Inclusion criteria: hemodynamically stable infants delivered by vaginal route with birthweight between 1200 and 1800 g

Exclusion criteria: neonates delivered by cesarean section, major life-threatening congenital malformations, severe perinatal complications, parental refusal of KMC intervention

Infant stabilization status at trial entry: stabilized

Infant age and weight at trial entry: Mean age at recruitment was 4.7 ± 2.9 and 4.8 ± 2.4 days, and mean weight was 1607 ± 211 and 1615 ± 179 g, for KMC and control infants, respectively

Interventions

KMC group: SSC between the mother's breasts in an upright position. Infants were dressed with a cap, socks, and a diaper and were supported at the bottom with a sling/binder. The duration of KMC during hospital stay was 6.3 ± 1.5 hours (range, 4 to 12) per day, and KMC was given for a period of 25.7 ± 6.9 (range, 15 to 43) days after enrollment in the study (n = 58)

Control group: Infants were kept in radiant warmers or open cots in warm rooms (n = 56)

In both groups, mothers were allowed to handle their babies at any hour of the day and to breastfeed them by nasogastric tube, by paladai, or directly. Babies in both groups were provided with vitamins and mineral supplementation

Level of care: NICU of a tertiary care hospital

Human resources: doctors and nurses

Criteria for infant discharge from the hospital: weight gain for ≥ 3 consecutive days, no overt illness, no intravenous medications, exclusive breastfeeding

Scheme for follow-up of infants after discharge: weekly until 40 weeks' postmenstrual age, fortnightly until 3 months' corrected age, and monthly thereafter until 6 months' corrected age

OutcomesDuration of hospital stay, weight gain, head circumference, length, exclusive breastfeeding, nosocomial sepsis, hypothermia, mild/moderate infection, severe infection, mortality
Notes81% of LBW infants met eligibility criteria
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskBlock randomization technique
Allocation concealment (selection bias)Unclear riskNo information provided
Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding of participants: no/unfeasible; blinding of clinical staff: no/unfeasible
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo information provided
Incomplete outcome data (attrition bias)
All outcomes
Low risk10 infants (8.8%) lost at 40 weeks' corrected gestational age follow-up (KMC 4, control 6), 21 (18.4%) lost at 3 months' corrected age (KMC 10, control 11), and 39 (34.2%) lost at 6 months' corrected age (KMC 19, control 20)
Selective reporting (reporting bias)High riskNon-significant results such as infant mortality and weight, length, and head circumference at discharge and follow-up (secondary outcomes listed in Methods) mentioned but not reported adequately
Other biasHigh riskUse of blocked randomization, which could make possible prediction of future assignments in an unblinded trial when assignments are revealed, subsequently to the person recruiting into the trial

Blaymore Bier 1996

MethodsRandomized controlled trial conducted in Providence, Rhode Island, United States
Participants

Number of infants: 50

Inclusion criteria: medically stable infants from singleton or multiple pregnancy with birth weight < 1500 g, whose mothers planned to breastfeed. Infants were no longer ventilator dependent and were without chest tubes, and they no longer required continuous positive airway pressure, when the study was begun

Exclusion criteria: mother's positive history of illicit drug use, mental illness, human immunodeficiency virus (HIV) infection, receiving any medications contraindicative to breastfeeding. In addition, any infants who had a positive toxicologic screen for cocaine or other illicit drugs or were showing drug withdrawal symptoms at birth were excluded

Infant stabilization status at trial entry: stabilized

Infant age and weight at trial entry: Mean age at recruitment was 29 and 30 days, and mean weight was 993 ± 275 and 942 ± 322 g, for KMC and control infants, respectively

Interventions

KMC group: SSC involved included the infant clothed in only a diaper and hat, held upright between the mother's breasts, with the mother and infant covered with a blanket (n = 25)

Control group: Standard contact involved a fully clothed infant wrapped in a blanket and held cradled in his or her mother's arms (n = 25)

During the study, the mother-infant dyad was observed participating in SSC or standard contact once each weekday until bottle feedings and breastfeedings were initiated, or for a maximum of 10 days. The duration of the SSC and of standard contact sessions was 10 minutes per day

Level of care: special care nursery of a hospital

Human resources: doctors and nurses

Criteria for infant discharge from the hospital: unreported

Scheme for follow-up of infants after discharge: at 1, 3, and 6 months after hospital discharge

OutcomesBreastfeeding and physiological data
NotesNo data on percentage of LBW infants who met eligibility criteria
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskShuffling of envelopes
Allocation concealment (selection bias)Unclear riskNo information provided
Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding of participants: no/unfeasible; blinding of clinical staff: no/unfeasible
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo information provided
Incomplete outcome data (attrition bias)
All outcomes
Low risk21 mothers of 25 infants allocated to KMC group, and 20 mothers of 25 infants to standard contact group. One mother in the KMC group lost to follow-up after discharge. Two mothers in the control group excluded because they wanted to participate in the KMC group
Selective reporting (reporting bias)Low riskAll outcomes stated in Methods section adequately reported or explained in Results
Other biasLow riskOther biases not identified

Boo 2007

MethodsRandomized controlled trial carried out in Kebangsaan, Malaysia
Participants

Number of infants: 128

Inclusion criteria: very low-birthweight infants (< 1501 g) in stable condition, nursed in a closed incubator, not requiring ventilatory support other than nasal continuous positive airway pressure, able to tolerate enteral feeds of ≥ 50% of required fluid volume, having ≥ 1 parent or guardian who was willing to participate in the study

Exclusion criteria: lethal or major malformations, severe perinatal asphyxia, with evidence of hypoxic ischemic encephalopathy, transfer to another hospital, abandoned by parents, parental refusal to participate

Infant stabilization status at trial entry: stabilized

Infant age and weight at trial entry: Median age at recruitment was 24.5 and 20.5 days, and median weight was 1514 and 1492 g, for KMC and control infants, respectively

Interventions

KMC group: Parent held the infant prone on naked chest, in a semi-upright position, and between his/her breasts. Infants wore only a nappy and a bonnet. Both parent and infant were covered with a thermal blanket. Median duration of SSC was 1 hour per day with a mean total duration of 12.7 ± 5.0 days (n = 65)

Control group: Infants were not exposed to SSC while in the NICU

All mothers were encouraged to breastfeed their infants (n = 63)

Level of care: NICU of a tertiary care hospital

Human resources: doctors and nurses

Criteria for infant discharge from the hospital: clinically well, able to tolerate oral feeds totally, weight gain ≥ 10 g/d, no apnea, bradycardia, and/or desaturation for ≥ 5 consecutive days

Scheme for follow-up of infants after discharge: unreported

OutcomesDuration of hospital stay, weight gain, weekly increase in head circumference, breastfeeding rate at discharge, sepsis, mortality at discharge
Notes43% of LBW infants met eligibility criteria
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskShuffling of envelopes
Allocation concealment (selection bias)Low riskNumbered sealed envelopes
Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding of participants: no/unfeasible; blinding of clinical staff: no/unfeasible
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskUnreported
Incomplete outcome data (attrition bias)
All outcomes
High risk8 infants in the KMC group (12.3%) excluded because SSC sessions were carried out on < 50% of hospital stay days after recruitment
Selective reporting (reporting bias)Low riskAll outcomes stated in Methods section adequately reported or explained in Results
Other biasLow riskOther biases not identified

Cattaneo 1998

MethodsMulticenter randomized controlled trial conducted in Addis Ababa (Ethiopia), Yogyakarta (Indonesia), and Merida (Mexico)
Participants

Number of infants: 285

Inclusion criteria: infants with birthweight between 1000 and 1999 g without gestational age limits, no dependency on oxygen and/or i.v. fluids, ability (at least partial) to feed, no visible major malformation, mother present and willing to collaborate

Exclusion criteria: unreported

Infant stabilization status at trial entry: stabilized

Infant age and weight at trial entry: Median age (range) at recruitment was 10 (1 to 74) and 8 (1 to 40) days, and and mean weight (SD) was 1584 (223) and 1574 (251) g, for KMC and control infants, respectively

Interventions

KMC group: Infants were kept in close and continuous SSC, between the mother's breasts, naked except for a diaper and a hat covered across their backs with their mother's clothes, day and night, for an average of about 20 hours/d, including when the mother was asleep. The mother was replaced occasionally, for a few hours, by another person, usually the father or a member of the family. For short absences of the mother (< 1 hour), the baby was left on the mother's bed, covered by a blanket (n = 149)

Control group: Infants were kept in a warm room in Addis Ababa, with open cribs and the possibility of rewarming in a bulb-heated cot, and in incubators in the other 2 hospitals. SSC with their mothers was not allowed (n = 136)

Level of care: neonatal units of teaching hospitals

Human resources: doctors and nurses

Criteria for infant discharge from the hospital: weight ≥ 1500 g, clear upward growth trend (≥ 15 g/kg/d) and stable temperature for ≥ 3 days, satisfactory ability to suck, good general conditions, mother considered capable of good home care

Scheme for follow-up of infants after discharge: ≥ 4 times, at 3, 10, 20, and 30 days, and as usually scheduled at each hospital afterward

OutcomesSevere illness, hypothermia, hyperthermia, breastfeeding, weight gain, neonatal death, acceptability to health workers, acceptability to mothers, costs
Notes44% of LBW infants met eligibility criteria
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandom number table
Allocation concealment (selection bias)Unclear riskNo information provided
Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding of participants: no/unfeasible; blinding of clinical staff: no/unfeasible
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskUnreported
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNumber of infants lost to follow-up or excluded after randomization not reported
Selective reporting (reporting bias)Low riskAll outcomes stated in Methods section adequately reported or explained in Results
Other biasUnclear riskIn Indonesia, randomization was carried out in blocks of 6 with stratification by weight, which could make prediction of future assignments possible in an unblinded trial when assignments are revealed subsequent to recruitment into the trial

Charpak 1997

MethodsRandomized controlled trial carried out in Bogotá, Colombia
Participants

Number of infants: 777

Inclusion criteria: infants from singleton or multiple pregnancies with birthweights ≤ 2000 g, with a mother or a relative able to understand and willing to follow general program instructions. Infants were eligible when they had overcome major problems of adaptation to extrauterine life, had received proper treatment for infection or a concomitant condition, sucked and swallowed properly, and had achieved a positive weight gain

Exclusion criteria: referred to another institution, plans to leave Bogotá in the near future, life-threatening or major malformations, early detected major conditions arising from perinatal problems, parental or family refusal to comply with the follow-up program; for those assigned to the KMC group, refusal to comply with specifics of the intervention

Infant stabilization status at trial entry: stabilized

Infant age and weight at trial entry: At recruitment, median age (range) was 4 (1 to 60) and 3 (1 to 55) days, and mean weight (SD) was 1678 (226) and 1715 (228) g, for KMC and control infants, respectively

Interventions

KMC group: Infants were kept 24 hours a day in a strict upright position, in SSC, while firmly attached to the mother's chest. Infants were breastfed regularly, although premature formula supplements were administered if necessary (n = 396)

Control group: Infants were kept in an incubator until they were able to regulate temperature and were thriving. Parents' access to their babies was severely restricted (n = 381)

Level of care: pediatric hospital (KMC infants) and NICU of a tertiary care hospital (controls)

Human resources: doctors and nurses

Criteria for infant discharge from the hospital: (1) For infants in the KMC group: temperature regulated in the kangaroo position, adequate weight gain, completion of treatment, if any; ability to be fed by direct suction from the breast or expressed milk, adequate sucking-swallowing-breathing coordination, and ability of mother to care for her baby using the kangaroo method at home. Infants were discharged from the hospital regardless of their weight or gestational age. (2) For infants in the control group: weight ≥ 1700 g

Scheme for follow-up of infants after discharge: at least once a week until 40 weeks' postmenstrual age; then, monthly up to 3 months' corrected age, every 6 weeks until at least 6 months' corrected age, and every third month until 12 months' corrected age

Outcomes

At 40 to 41 weeks' postmenstrual: mortality, infant growth, length of hospital stay, infection, breastfeeding, and mother-infant attachment

At 12 months' corrected age: neurodevelopmental disability, and social and home environment

Notes72% of LBW infants met eligibility criteria. Informed consent was not asked of parents of infants allocated to the control group. Additional data provided by Dr Nathalie Charpak
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandom number table
Allocation concealment (selection bias)Unclear riskPerson managing allocation aware of weight at birth and whether the infant was a twin or a triplet
Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding of participants: no/unfeasible; blinding of clinical staff: no/unfeasible
Blinding of outcome assessment (detection bias)
All outcomes
High riskInfants allocated to KMC group were managed in a pediatric hospital, whereas infants allocated to control group remained in an NICU of a tertiary care hospital
Incomplete outcome data (attrition bias)
All outcomes
Low risk31 infants (4%) (KMC 14, control 17) excluded after randomization owing to pre-existing neurological impairment, or fetal intrauterine infection not detected at time of randomization. Follow-up at 40 to 41 weeks' corrected gestational age incomplete for 67 (8.6%) survivor infants (KMC 33, control 34), but mortality data available for 30 of these, yielding mortality data for 364 vs 345
Selective reporting (reporting bias)Low riskAll outcomes stated in Methods section adequately reported or explained in Results
Other biasHigh riskUse of blocked randomization (block size of 4), which could make possible prediction of future assignments in an unblinded trial when assignments are revealed subsequent to recruitment of the person into the trial

Eka Pratiwi 2009

MethodsRandomized controlled trial conducted in Bali, Indonesia
Participants

Number of infants: 93

Inclusion criteria: infants with birthweight between 1500 and 2250 g, with Apgar score > 6 at 5 minutes, and mother willing to follow study instructions

Exclusion criteria: infants with major congenital malformations, cardiopulmonary problems, critical illness (sepsis, necrotizing enterocolitis, intracranial bleeding); twin gestation or complicated pregnancy and/or labor; mothers with history of drug abuse, psychiatric disorders, or cesarean section, or unable to take care of themselves or their babies

Infant stabilization status at trial entry: stabilized

Infant age and weight at trial entry: Mean birthweight at recruitment was 2034 ± 159 and 1988 ± 176 g for KMC and control infants, respectively. No data on infant age at recruitment. However, researchers mentioned that KMC was started "in the first day or in several hours after birth"

Interventions

KMC group: Infants were kept in close SSC with the mother whilst in vertical position. Specially tailored kangaroo suits were used by mother-infant pairs to enable SSC. Mean duration of KMC was 10.0 ± 1.8 hours per day (range, 5.3 to 13.5 hours) (n = 48)

Control group: Infants were kept in incubators or open cribs in warm rooms (n = 45)

Level of care: NICU of a public hospital

Human resources: doctors and nurses

Criteria for infant discharge from the hospital: unreported

Scheme for follow-up of infants after discharge: unreported

OutcomesHypothermia, birthweight regain, sepsis, mortality
Notes37% of LBW infants met eligibility criteria
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandom number table
Allocation concealment (selection bias)Unclear riskNo information provided
Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding of participants: no/unfeasible; blinding of clinical staff: no/unfeasible
Blinding of outcome assessment (detection bias)
All outcomes
High riskUnblinded assessors
Incomplete outcome data (attrition bias)
All outcomes
Low riskOne infant (1%) lost to follow-up; 4 (4.1%) excluded after randomization owing to sepsis
Selective reporting (reporting bias)Low riskAll outcomes stated in Methods section adequately reported or explained in Results
Other biasHigh riskUse of block randomization (block size of 6), which could make possible prediction of future assignments in an unblinded trial when assignments are revealed subsequent to recruitment of the person into the trial

Gathwala 2008

MethodsRandomized controlled trial carried out in Rohtak, India
Participants

Number of infants: 110

Inclusion criteria: infants with birthweight ≤ 1800 g, stable cardiopulmonary status, Apgar score ≥ 7 at 1 and 5 minutes, tolerating enteral feeds, and maintaining temperature

Exclusion criteria: infants sick, unstable, or with major congenital malformations, or whose mothers were unwell and unable to come or refused consent

Infant stabilization status at trial entry: stabilized

Infant age and weight at trial entry: Mean age at recruitment was 1.7 ± 0.5 days, and mean birthweight was 1690 ± 110 and 1690 ± 120 g, for KMC and control infants, respectively. No data on infant weight at recruitment

Interventions

KMC group: Infants were kept in SSC, between the mother's breasts, naked except for a cap and nappy, for ≥ 6 hours per day. Duration of KMC in the first month was 10.2 ± 1.5 hours per day, in the second month 10.0 ± 1.6, and in the third month 9.0 ± 1.4. The gown covered the baby's trunk and extremities, but not the head. KMC was given for a minimum of 1 hour at a stretch and was continued for as long as it was comfortable for baby and mother. When not receiving KMC, infants received standard care under a warmer or incubator. Infants continued to receive KMC after they were shifted to the mother in the ward (n = 50)

Control group: Infants were kept in a warmer or incubator. Mothers were allowed to visit their babies and touch and handle them. Infants were shifted to the mother in her bed but did not receive KMC (n = 50)

Level of care: neonatal unit of a public hospital

Human resources: doctors and nurses

Criteria for infant discharge from the hospital: unreported

Scheme for follow-up of infants after discharge: weekly until 3 months of age

OutcomesAttachment between mother and infant at 3 months' follow-up; duration of hospital stay; breastfeeding; weight, length and circumference head gain
NotesNo data on percentage of LBW infants who met eligibility criteria
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandom number table
Allocation concealment (selection bias)Unclear riskNo information provided
Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding of participants: no/unfeasible; blinding of clinical staff: no/unfeasible
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskUnreported
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk10 infants (9.1%) lost to follow-up. Number of infants lost to follow-up in each intervention group not reported. Of the remaining 100, 50 received KMC and 50 standard care
Selective reporting (reporting bias)Low riskAll outcomes stated in Methods section adequately reported or explained in Results
Other biasLow riskOther biases not identified

Ghavane 2012

MethodsRandomized controlled trial conducted in Hyderabad, India
Participants

Number of infants: 140

Inclusion criteria: infants with birthweight < 1500 g, tolerating spoon feeds of 150 mL/kg/d, and hemodynamically stable (not receiving oxygen or respiratory support, no apnea for 72 hours, not receiving intravenous fluids)

Exclusion criteria: major malformations, refused consent

Infant stabilization status at trial entry: stabilized

Infant age and weight at trial entry: Mean age at recruitment was 14.1 ± 10.3 and 13.7 ± 10.2 days, and mean weight was 1191 ± 131 and 1223 ± 125 g, for KMC and control infants, respectively

Interventions

KMC group: Infants were kept in SSC, between the mother's breasts, in an upright position, dressed with a cap, socks, and diaper, and supported at the bottom with a cloth sling/binder, for ≥ 8 hours per day. When not receiving KMC, infants were placed in open cribs (n = 71)

Control group: Infants were kept in a warmer or incubator. Mothers were allowed to visit their babies and were encouraged to perform infant care activities such as diaper change, oil massage, and paladai feeding (n = 69)

Level of care: "kangaroo ward" (KMC infants) and neonatal intermediate care unit (controls) at a level III tertiary care hospital

Human resources: Infants in KMC group were cared for solely by their mothers, assisted by a trained nurse. Infants in control group were cared for by doctors and nurses

Criteria for infant discharge from the hospital: (1) For infants in KMC group: weight ≥ 1300 g or weight gain ≥ 10 g/d on 3 consecutive days if weight at randomization was > 1300 g. (2) For infants in control group: weight ≥ 1300 g, weight gain ≥ 10 g/d on 3 consecutive days, and skin temperature of 36°C to 37°C in the servo mode of the incubator with heater output < 25%

Scheme for follow-up of infants after discharge: weekly until 40 weeks' postmenstrual age

Outcomes

At 40 weeks' postmenstrual age: infant growth

At discharge: breastfeeding, sepsis, hypothermia, apnea, hypoglycemia, length of hospital stay, mortality

NotesNo data on percentage of LBW infants who met eligibility criteria. Additional data provided by Dr Srinivas Murki
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskWeb-based random number generator
Allocation concealment (selection bias)Low riskNumbered sealed opaque envelopes
Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding of participants: no/unfeasible; blinding of clinical staff: no/unfeasible
Blinding of outcome assessment (detection bias)
All outcomes
Low riskPhysician who assessed growth outcomes was blinded to infants' intervention group
Incomplete outcome data (attrition bias)
All outcomes
Low risk4 infants (2.9%) lost to follow-up (KMC 3, control 1); no exclusions
Selective reporting (reporting bias)Low riskAll outcomes stated in Methods section adequately reported or explained in Results
Other biasLow riskOther biases not identified

Kadam 2005

MethodsRandomized controlled trial carried out in Mumbai, India
Participants

Number of infants: 89

Inclusion criteria: infants with birthweight ≤ 1800 g, stable cardiopulmonary status, Apgar score ≥ 7 at 5 minutes, and on feeds (breastfeeds or spoon wati feeds with expressed breast milk)

Exclusion criteria: infants sick and unstable, or with major congenital malformations, or whose parents refused consent

Infant stabilization status at trial entry: stabilized

Infant age and weight at trial entry: Mean age (range) at enrollment was 3.2 (1 to 8) days for both groups. Mean birthweight was 1467 ± 228 and 1461 ± 217 g for KMC and control infants, respectively. No data on infant weight at recruitment

Interventions

KMC group: Infants were placed on mother's chest in between the breasts in a vertical position, supported by a cloth dupatta, with mothers seated in a semi reclining position, for a mean of 9.8 ± 3.7 hours per day. In case of any problem, the baby was transferred to conventional care, and after stabilization was transferred back to KMC, which was continued till discharge (n = 44)

Control group: Infants were kept in radiant warmers (n = 45)

More than 95% of infants in both groups received exclusive breastfeeding; the remaining were supplemented by banked human milk. Mothers in both groups were allowed to enter and handle the babies at any hour of the day, change diapers, and breastfeed the babies

Level of care: NICU of a tertiary care hospital

Human resources: doctors and nurses

Criteria for infant discharge from the hospital: weight gain for ≥ 3 consecutive days, maintenance of temperature without the need for a warmer, feeding well on breastfeeds or wati spoon-feeds, and mother confident of taking care of the infant at home

Scheme for follow-up of infants after discharge: unreported

OutcomesMortality, morbidity (hypothermia, hyperthermia, sepsis, apnea), onset of breastfeeding, duration of hospital stay, weight at discharge
NotesNo data on percentage of LBW infants who met eligibility criteria
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskSealed envelope method
Allocation concealment (selection bias)Low riskSealed envelopes
Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding of participants: no/unfeasible; blinding of clinical staff: no/unfeasible
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskUnreported
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo infants lost to follow-up
Selective reporting (reporting bias)Low riskAll outcomes stated in Methods section adequately reported or explained in Results
Other biasLow riskOther biases not identified

Kumbhojkar 2016

MethodsRandomized controlled trial conducted in Kolhapur, India
Participants

Number of infants: 120

Inclusion criteria: stable infants with birthweight < 2000 g

Exclusion criteria: infants critically ill requiring ventilator support or inotropic support, or with chromosomal and life-threatening congenital anomalies, or whose mother was critically ill or unable to comply with the follow-up schedule

Infant stabilization status at trial entry: stabilized

Infant age and weight at trial entry: Mean age at recruitment was 3 and 4 days, and mean weight was 1610 ± 200 and 1627 ± 204 g, for KMC and control infants, respectively

Interventions

KMC group: Infants were kept in SSC using a specially tailored "kangaroo bag" made of soft flannel cloth on the reclining cot in the semi upright position with the help of pillows. Mothers were encouraged to keep the baby in KMC as long as possible during the day and night for a minimum period of 1 to 2 hours at a time. When the baby was receiving intravenous fluids, the mother provided kangaroo care while seated in a comfortable chair placed close to the baby's cradle. Mean duration of KMC was 11.5 hours per day. No data on total number of days that KMC was given after enrollment (n = 60)

Control group: Infants were managed under a servo-controlled radiant warmer or in a cradle under hot lamp in NICU, adequately clothed and covered (n = 60)

All babies were exclusively breastfed and also received calcium, phosphorus, and multivitamin supplements. Infants who developed a life-threatening event or required phototherapy were temporarily withdrawn from the KMC group

Level of care: NICU of a tertiary care hospital

Human resources: doctors and nurses

Criteria for infant discharge from the hospital: weight gain of 10 to 15 g/kg/d for ≥ 3 consecutive days, maintenance of temperature without assistance, feeding well, and mother confident of taking care of the infant at home

Scheme for follow-up of infants after discharge: weekly until 40 weeks' postmenstrual age in preterm infants, or until a weight of 2500 g was reached in term SGA infants. Home visits were not possible

OutcomesGain in weight, length, and head circumference; hospital stay; hypothermia; sepsis; apnea; acceptability of KMC; breastfeeding
NotesNo data on percentage of LBW infants who met eligibility criteria
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskSimple randomization
Allocation concealment (selection bias)Low riskSealed envelopes
Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding of participants: no/unfeasible; blinding of clinical staff: no/unfeasible
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskUnreported
Incomplete outcome data (attrition bias)
All outcomes
High riskNo information on infants lost to follow-up nor on exclusions. However, it was stated in the Discussion section that poor follow-up in the control group was a limitation of this study
Selective reporting (reporting bias)Low riskAll outcomes stated in Methods section reported or explained in Results
Other biasLow riskOther biases not identified

Nagai 2010

MethodsRandomized controlled trial conducted in Mahajanga, Madagascar
Participants

Number of infants: 73

Inclusion criteria: infants with birthweight < 2500 g, < 24 hours post birth, no serious malformation, relatively stable clinical condition (oxygen saturation ≥ 95%; heart rate > 100 beats/min; respiratory rate < 60 times/min; capillary refilling time < 3 seconds), and healthy mother and/or other family members willing to practice KMC

Exclusion criteria: prolonged apnea (> 20 seconds) and intravenous infusion

Infant stabilization status at trial entry: relatively stabilized

Infant age and weight at trial entry: Mean age at recruitment was 19.8 ± 14.3 and 33.0 ± 13.2 hours, and mean weight was 2075 ± 272 and 2078 ± 292 g, for early-onset KMC and late-onset KMC infants, respectively

Interventions

Early KMC group: Infants were kept in direct and continuous SSC (without underwear, except for a diaper, a warm hat, and socks for the baby) for as long as possible. SSC was begun as soon as possible, within 24 hours post birth (n = 37)

Late KMC group: Initially, infants were kept in an incubator or radiant warmer. Later, infants were covered with cotton cloth and were laid beside their mothers. KMC was begun after complete stabilization (generally after 24 hours post birth) of infant (n = 36)

After KMC was initiated, all participants were encouraged to continue KMC for as long as possible during hospitalization and after discharge. Other family members assisted the mother occasionally in performing continuous KMC

Level of care: neonatal unit of a referral university hospital

Human resources: doctors and nurses

Criteria for infant discharge from the hospital: unreported

Scheme for follow-up of infants after discharge: at 14 and 28 days of age

Outcomes

Primary outcome: mortality at 4 weeks of age

Secondary outcomes: morbidity; severe infection; re-admission to hospital; adverse events (hypothermia, hyperthermia, bradycardia and/or tachycardia, and prolonged apnea) at 4 weeks of age; body weight changes from birth to 24 hours, 48 hours, 14 days, and 28 days post birth; length of hospital stay; discharge within 7 days post birth; exclusive breastfeeding at 24 and 48 hours, 2 and 4 weeks, and 6 months post birth; mortality; re-admission to hospital; nutritional indicators at 6 to 12 months of age

Notes52% of LBW infants met eligibility criteria
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskMinimization method by software "minim"
Allocation concealment (selection bias)Low riskSoftware automatically provided random allocation for each participant
Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding of participants: no/unfeasible; blinding of clinical staff: no/unfeasible
Blinding of outcome assessment (detection bias)
All outcomes
Low riskA neonatologist who was masked to allocation of participants and had no contact with participants determined the classification of morbidities using interview records and medical charts
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo infants lost to follow-up
Selective reporting (reporting bias)Low riskAll outcomes stated in Methods section adequately reported or explained in Results
Other biasLow riskOther biases not identified

Neu 2010

MethodsRandomized controlled trial carried out in Aurora, Colorado, United States
Participants

Number of infants: 60

Inclusion criteria: healthy infants with gestational age between 32 and 34 weeks, oxygen requirement < ½ liter O2 per nasal cannula, infant without umbilical lines, intraventricular hemorrhage, physical anomalies or anticipated major surgery, mother fluent in English or Spanish without recorded or stated illicit drug use, or diagnosis of serious chronic illness

Exclusion criteria: unreported

Infant stabilization status at trial entry: stabilized

Infant age and weight at trial entry: Mean age at recruitment was 15.0 ± 6.7 and 15.0 ± 4.9 days, and mean birthweight was 1990 ± 450 and 1880 ± 340 g, for KMC and control infants, respectively

Interventions

KMC group: infant in SSC on mother's chest for 60 consecutive minutes at least once daily over 8 weeks (n = 31)

Control group: infant wrapped in blanket and held in mother's arms for 60 consecutive minutes at least once daily over 8 weeks (n = 29)

In both conditions, weekly home visits by an experienced registered nurse included encouragement to hold the infant, emotional support, and information about infant behavior and development. Other control group received brief social visits with no holding constraints and participated in all assessments. In the meta-analysis, we excluded results from this last control group

Level of care: initially at the hospital, then at home

Human resources: nurses

Criteria for infant discharge from the hospital: not applicable

Scheme for follow-up of infants after discharge: twice a week for 2 weeks, followed by weekly visits for 6 months

OutcomesMother-infant interaction at 6 months' follow-up and infant vitality during the neutral-face period of the Still-Face Procedure
NotesNo data on percentage of LBW infants who met eligibility criteria. Approximately 60% of mothers who were approached declined to be included in the study
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer random number generator
Allocation concealment (selection bias)Low riskOpaque sealed envelopes
Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding of participants: no/unfeasible; blinding of clinical staff: no/unfeasible
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskFour researchers assessed outcome measures. Two outcome assessors were blinded to the hypotheses of the study but not to group assignment of mother-infant dyads. The other 2 researchers were blinded to group assignment and hypotheses
Incomplete outcome data (attrition bias)
All outcomes
High risk87 infants were randomized: 31 to KMC, 29 to traditional holding, and 36 to control. At 6 months of age, 8 infants (9.2%) were lost to follow-up and 14 (16.1%) were excluded (8 withdrawn for maternal reasons and 6 because of technical problems during videotaping)
Selective reporting (reporting bias)Low riskAll outcomes stated in Methods section adequately reported or explained in Results
Other biasLow riskOther biases not identified

Nimbalkar 2014

MethodsRandomized controlled trial conducted in Karamsad, India
Participants

Number of infants: 100, of whom 45 were LBW

Inclusion criteria: stable infants delivered vaginally with birthweight ≥ 1800 g

Exclusion criteria: infants delivered by cesarean section or needing any resuscitation measures or with any congenital malformation at birth

Infant stabilization status at trial entry: stabilized

Infant age and weight at trial entry: Mean age was 43 ± 13 minutes in the KMC group and 30 to 60 minutes in the control group. Mean birthweight (and weight at recruitment) was 2622 ± 399 g and 2589 ± 443 g for KMC and control infants, respectively

Interventions

KMC group: Mothers started SSC 30 minutes to 1 hour after delivery and continued for as long as possible in the first 24 hours, with each session lasting a minimum of 60 minutes. SSC was discontinued after 24 hours and conventional care was provided for next 24 hours of life. Mean duration of KMC was 17.0 ± 0.3 hours during first 24 hours (n = 22)

Control group: Infants were kept clothed (including head cap) and covered with a blanket with their mother (bedding in) for first 48 hours (n = 23)

In both groups, infants were taken under radiant warmers immediately after delivery and were exclusively breastfed

Level of care: maternity ward of a tertiary care hospital

Human resources: doctors and nurses

Criteria for infant discharge from the hospital: unreported

Scheme for follow-up of infants after discharge: unreported

OutcomesHypothermia within first 48 hours of life
Notes43% of infants met eligibility criteria. Results for the 45 LBW infants reported separately
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskWeb-based software (WINPEPI)
Allocation concealment (selection bias)Low riskSealed opaque envelopes
Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding of participants: no/unfeasible; blinding of clinical staff: no/unfeasible
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskUnreported
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo infants lost to follow-up
Selective reporting (reporting bias)Low riskAll outcomes stated in Methods section adequately reported or explained in Results
Other biasLow riskOther biases not identified

Ramanathan 2001

MethodsRandomized controlled trial conducted in New Delhi, India
Participants

Number of infants: 28

Inclusion criteria: infants with birthweight < 1500 g, stable cardiopulmonary status, tolerating enteral feeds, and maintaining temperature in the thermoneutral environment

Exclusion criteria: infants whose mothers were unable to come to the nursery because of illness or disability

Infant stabilization status at trial entry: stabilized

Infant age and weight at trial entry: Median age at initiation of KMC was 11.8 days. Mean birthweight was 1219 ± 186 and 1271 ± 170 g for KMC and control infants, respectively. No data on infant weight at recruitment

Interventions

KMC group: Infants were kept between the mother's breasts for ≥ 4 hours per day in not more than 3 sittings. The gown covered the baby's trunk and extremities but not the head. When not receiving KMC, infants received standard care under a warmer or incubator (n = 14)

Control group: Infants were kept in a warmer or incubator. Mothers were allowed to visit their babies and touch and handle them (n = 14)

Breastfeeding guidelines were followed for both groups and lactational counseling was emphasized to ensure breast milk feeding

Level of care: NICU of a tertiary care hospital

Human resources: doctors and nurses

Criteria for infant discharge from the hospital: weight > 1400 g, “adequate” weight gain, gestation over 34 weeks, only on enteral feeds, no intravenous medications, no overt illness, exclusive breastfeeding, and mother confident of taking care of the infant at home

Scheme for follow-up of infants after discharge: unreported

OutcomesWeight gain, breastfeeding, duration of hospitalization
NotesNo data on percentage of LBW infants who met eligibility criteria. Infants in KMC group required positive-pressure ventilation, continuous positive airway pressure, and oxygen therapy over greater duration than infants in control group, indicating that these infants were sicker before enrollment
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandom number table
Allocation concealment (selection bias)Unclear riskNo information provided
Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding of participants: no/unfeasible; blinding of clinical staff: no/unfeasible
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskUnreported
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo infants lost to follow-up
Selective reporting (reporting bias)Unclear riskNeonatal complications prospectively recorded but not reported
Other biasLow riskOther biases not identified

Roberts 2000

MethodsRandomized controlled trial carried out in Darwin, Australia
Participants

Number of infants: 30

Inclusion criteria: premature or small for gestational age infants born at 30 or more weeks' gestation or corrected age, with 5-minute Apgar of ≥ 5, medically stable, without congenital abnormalities or central nervous system impairment. Infants could have received nasal continuous positive airway pressure in place or a nasal cannula

Exclusion criteria: phototherapy within previous 24 hours, resuscitated infants, mothers with a history of drug use

Infant stabilization status at trial entry: stabilized

Infant age and weight at trial entry: Mean age at recruitment was 31.5 ± 2.7 days and mean weight was 1690 ± 333 g, respectively

Interventions

KMC group: Infants were dressed in only a diaper, with a bonnet added for smaller infants. They were placed on the mother's skin and covered with a light blanket. Mean duration of KMC was 1.6 ± 0.9 hours per day, 5 days a week (n = 16)

Control group: Infants were swaddled in infant clothing and a light blanket. They had contact with the mother only through normal clothing (n = 14)

Breastfeeding was permitted as desired in both groups

Level of care: neonatal intensive care nurseries of 2 hospitals

Human resources: doctors and nurses

Criteria for infant discharge from the hospital: unreported

Scheme for follow-up of infants after discharge: at 6 weeks after discharge or at 3 months of age, whichever was later, and at 6 months of age

OutcomesWeight gain, length of stay in hospital, temperature, breastfeeding
NotesNo data on percentage of LBW infants who met eligibility criteria
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskShuffling envelopes
Allocation concealment (selection bias)Low riskNumbered envelopes
Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding of participants: no/unfeasible; blinding of clinical staff: no/unfeasible
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskUnreported
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo infants lost to follow-up
Selective reporting (reporting bias)Low riskAll outcomes stated in Methods section adequately reported or explained in Results
Other biasLow riskOther biases not identified

Rojas 2003

MethodsRandomized controlled trial conducted in Connecticut, United States
Participants

Number of infants: 60

Inclusion criteria: very low birthweight infants (< 1501 g) with gestational age ≤ 32 weeks, with minimal ventilatory support or extubated on nasal continuous positive airway pressure or nasal canula, with hemodynamic stability

Exclusion criteria: mother's age < 18 years, history of illicit drug use during pregnancy, clinical evidence of perinatal asphyxia, potential transfer within the first month after birth, presence of a major congenital anomaly, planned adoption, grade III or IV intraventricular hemorrhage, fetal growth restriction, suspected sepsis

Infant stabilization status at trial entry: stabilized

Infant age and weight at trial entry: Mean age at trial entry was 19 days, and mean weight was 1021 ± 268 g and 1002 ± 219 g for KMC and control infants, respectively

Interventions

KMC group: Infants were held in a prone semi upright position at approximately a 45° angle, in direct SSC with the parent's chest. Infants wore only a diaper, and their backs were covered with a blanket. Mean duration of KMC was 1.3 ± 0.7 hours per day for an average of 15 ± 16 days (n = 33)

Control group: Parents removed their infants from the incubator and held them in their arms in supine position with eye-to-eye contact. Infants wore diapers and T-shirts and were wrapped in a blanket (n = 27)

Level of care: NICU of a hospital

Human resources: doctors and nurses

Criteria for infant discharge from the hospital: unreported

Scheme for follow-up of infants after discharge: not performed

OutcomesMortality at discharge; sepsis; necrotizing enterocolitis; intraventricular hemorrhage; weight, head circumference, and length at discharge; rate of weight gain and head circumference growth; total weight gain and head circumference growth; breastfeeding at discharge; hospital stay
Notes19% of LBW infants met eligibility criteria
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandom number table
Allocation concealment (selection bias)Low riskNumbered sealed opaque envelopes
Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding of participants: no/unfeasible; blinding of clinical staff: no/unfeasible
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskUnreported
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo infants lost to follow-up
Selective reporting (reporting bias)Low riskAll outcomes stated in Methods section adequately reported or explained in Results
Other biasLow riskOther biases not identified

Sloan 1994

MethodsRandomized controlled trial carried out in Quito, Ecuador
Participants

Number of infants: 300

Inclusion criteria: singleton infants weighing < 2000 g, with no serious congenital abnormalities or respiratory, metabolic, or infectious disease. Infants had to be stabilized for 24 hours before enrollment (temperature between 36.5°C and 37.0°C); acceptable tolerance of food; stable weight

Exclusion criteria: unreported

Infant stabilization status at trial entry: stabilized

Infant age and weight at trial entry: Mean age at recruitment was 13.0 ± 10.5 days, and mean weight was 1618 ± 317 g, respectively

Interventions

KMC group: Infants were kept in an upright position, in SSC contact (diapers allowed) against the mother's breasts, and had frequent breastfeeding. SSC was reported by 68% of mothers at follow-up of 1 month, 47% at 1.5 months, 20% at 2 months, and 7% at 3 months (n = 140)

Control group: Infants stayed in an incubator or thermal crib and were breastfed at scheduled times (n = 160)

Level of care: NICU of a maternity hospital

Human resources: doctors and nurses

Criteria for infant discharge from the hospital: unreported

Scheme for follow-up of infants after discharge: at 1, 1.5, 2, 3, 4, 5, and 6 months of age

OutcomesSevere illness (lower respiratory tract disorder, apnea, aspiration, pneumonia, septicemia, general infection), moderate illness (urinary infection), mild illness (upper respiratory tract disorder, dermatitis, jaundice, hip displacement), diarrhea, infant growth (weight, length, upper arm and head circumference), duration of hospital stay, re-admission, costs of care
Notes53% of LBW infants met eligibility criteria. Additional data provided by Dr Nancy L. Sloan
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandom number table
Allocation concealment (selection bias)Unclear riskNo information provided
Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding of participants: no/unfeasible; blinding of clinical staff: no/unfeasible
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskUnreported
Incomplete outcome data (attrition bias)
All outcomes
Low riskOutcome data reported for 131 KMC infants and 152 controls. 17 infants (5.7%) lost to follow-up (KMC 9, control 8); no exclusions
Selective reporting (reporting bias)Unclear riskSecondary outcomes such as infant growth indices at follow-up and costs of care were mentioned but were not reported adequately
Other biasUnclear riskTrial was stopped early because a highly significant difference (P value < 0.02 at 2 months, P value < 0.005 at 6 months) in severe morbidity arose. No information about whether this was a planned interim analysis

Suman 2008

MethodsRandomized controlled trial conducted in Mumbai, India
Participants

Number of infants: 220

Inclusion criteria: singleton infants with birthweight < 2000 g

Exclusion criteria: infants critically ill requiring ventilatory or inotropic support, or with chromosomal and life-threatening congenital anomalies, or requiring transfer, or whose mothers were critically ill or unable to comply with the follow-up schedule

Infant stabilization status at trial entry: stabilized

Infant age and weight at trial entry: Mean age at recruitment was 3.7 ± 2.8 and 2.3 ± 1.9 days, and mean weight was 1608 ± 278 and 1691 ± 273 g, for KMC and control infants, respectively

Interventions

KMC group: Infants were kept in SSC using a specially tailored "kangaroo bag" made of soft flannel cloth on the reclining cot in the semi upright position with the help of pillows. Mothers were encouraged to keep the baby in KMC as long as possible during the day and night, for a minimum period of 1 to 2 hours at a time. When not in KMC, the baby was placed under a servo-controlled radiant warmer or in a cradle under a hot lamp adequately clothed and covered. Mean duration of KMC was 13.5 hours per day, with a mean total duration of 33.8 ± 15.1 days (n = 108)

Control group: Infants were managed under a servo-controlled radiant warmer or in a cradle under a hot lamp in the NICU adequately clothed and covered (n = 112)

All babies were exclusively breastfed. Infants who developed a life-threatening event or required phototherapy were temporarily withdrawn from the KMC group

Level of care: NICU of a tertiary care hospital

Human resources: doctors and nurses

Criteria for infant discharge from the hospital: weight gain of 10 to 15 g/kg/d for ≥ 3 consecutive days, maintenance of temperature without assistance, feeding well, and mother confident of taking care of the infant at home

Scheme for follow-up of infants after discharge: weekly until 40 weeks' postmenstrual age in preterm infants, or until a weight of 2500 g was reached in term SGA infants

OutcomesInfant growth (weight, length, head, chest, mid-arm circumference, and foot length), mortality, morbidity (hypothermia, hyperthermia, hypoglycemia, sepsis, apnea in < 1500 g, other minor illness), duration of hospital stay
Notes63% of LBW infants met eligibility criteria
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskSimple randomization
Allocation concealment (selection bias)Low riskSealed envelopes
Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding of participants: no/unfeasible; blinding of clinical staff: no/unfeasible
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskUnreported
Incomplete outcome data (attrition bias)
All outcomes
High risk49 infants (22.3%) lost to follow-up (KMC 11 [10.2%], control 38 [33.9%]); 14 babies (6.4%) were excluded (KMC 5, control 9) because they did not receive assigned care
Selective reporting (reporting bias)Low riskAll outcomes stated in Methods section adequately reported or explained in Results
Other biasUnclear riskGroups were different at baseline in 2 important variables: (1) weight at enrollment (1608 ± 278 g and 1691 ± 273 g for KMC and control infants, respectively; P value = 0.03), and (2) age at enrollment (3.7 ± 2.8 days and 2.3 ± 1.9 days for KMC and control infants, respectively; P value < 0.01)

Whitelaw 1988

MethodsRandomized controlled trial carried out in London, United Kingdom
Participants

Number of infants: 71

Inclusion criteria: infants from singleton or twin pregnancy with weight < 1500 g, stable breathing with no oxygen requirement, and ≥ 1 parent speaking fluent English. Stable infants were not excluded if they had congenital malformations such as hydronephrosis or scoliosis, nor if they had intracranial lesions such as periventricular leukomalacia or ventricular dilatation

Exclusion criteria: unreported

Infant stabilization status at trial entry: stabilized

Infant age and weight at trial entry: Mean (range) age at enrollment was 16 (1 to 66) days. Mean birthweight was 1152 ± 220 g and 1135 ± 263 g for KMC and control infants, respectively. No data on infant weight at recruitment

Interventions

KMC group: Infants were kept in an upright position, in SSC between the mother's breasts, with a cardiac or respiration monitor attached. Mean (range) duration of KMC was 0.6 (0 to 1.5) hours per day (n = 35)

Control group: Mother was encouraged to visit as much as she liked and helped to take her baby out of the incubator for a cuddle. However, baby and mother remained clothed Care was taken that the normal contact group would receive no less attention from the nursing staff (n = 36)

Level of care: NICU of a hospital

Human resources: doctors and nurses

Criteria for infant discharge from the hospital: unreported

Scheme for follow up of infants after discharge: at 6, 9, and 12 months of age

OutcomesBreastfeeding and infant's behavior at 6 months of age, mother's feelings about the infant at discharge and at 6 months of age
Notes50% of LBW infants met eligibility criteria
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskShuffling of envelopes
Allocation concealment (selection bias)Low riskSequentially numbered sealed opaque envelopes
Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding of participants: no/unfeasible; blinding of clinical staff: no/unfeasible
Blinding of outcome assessment (detection bias)
All outcomes
High riskNo
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo infants lost to follow-up
Selective reporting (reporting bias)Unclear riskNon-significant results for some outcome measures (eg, mother's feelings about the infant at discharge and at 6 months' follow-up) were mentioned but were not reported adequately
Other biasLow riskOther biases not identified

Worku 2005

  1. a

    KMC = kangaroo mother care
    LBW = low birthweight
    SSC = skin-to-skin contact
    SGA = small for gestational age

MethodsRandomized controlled trial carried out in Addis Ababa, Ethiopia
Participants

Number of infants: 123

Inclusion criteria: infants with birthweight < 2000 g, singletons unless 1 of the twins died, no major congenital malformations, and mother healthy and willing to participate

Exclusion criteria: unreported

Infant stabilization status at trial entry: non-stabilized

Infant age and weight at trial entry: Mean age at enrollment was 10.0 and 9.8 hours, and mean birthweight was 1515 g and 1472 g for KMC and control infants, respectively

Interventions

Early KMC group: Infants were kept in continuous SSC with their mother beginning immediately after birth or within the first 24 hours of life (before stabilization). The mother kept her newborn infant between the breasts, in close contact with her body and covered with her clothes day and night. Breastfeeding was the standard feeding method. However, the mother could also feed her baby with formula milk using tube or cup when needed. KMC could be combined with a heated room during low environmental temperatures (n = 62)

Control group: Infants were kept in a heated room with overhead lamp warmers and received oxygen therapy and breast, tube, cup, or mixed feeding (n = 61)

The 2 methods of care were applied and continued until the baby was considered stabilized (stable temperature, stabilized cardiovascular status, satisfactory ability to suck, and good general condition); then both group of babies were transferred to the ward for routine kangaroo care service. KMC was continued at home after discharge in both groups

Level of care: neonatal unit of a teaching hospital

Human resources: doctors and nurses

Criteria for infant discharge from the hospital: (1) for discharge from the study to the ward routine kangaroo care service: stable temperature, stabilized cardiovascular status, satisfactory ability to suck, and good general condition; (2) for discharge from the hospital: "according to the hospital's protocol"

Scheme for follow-up of infants after discharge: unreported

OutcomesDeath, serious illness (sepsis, diarrhea, pneumonia, aspiration, pneumonia), mothers' feeling about the method of care
Notes48% of LBW infants met eligibility criteria
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandom number table
Allocation concealment (selection bias)Unclear riskNo information provided
Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding of participants: no/unfeasible; blinding of clinical staff: no/unfeasible
Blinding of outcome assessment (detection bias)
All outcomes
High riskNo
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNo information on infants lost to follow-up; no exclusions
Selective reporting (reporting bias)High riskGreat majority of outcomes listed in Methods section of the article, such as weight gain, mild/moderate and severe illness, sepsis, diarrhea, pneumonia, aspiration, and mother's feelings, collected but not reported
Other biasLow riskOther biases not identified

Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion
  1. a

    KMC = kangaroo mother care
    LBW = low birthweight
    SSC = skin-to-skin contact
    SGA = small for gestational age

Ahn 2010Not a randomized controlled trial
Anderson 2003Study compared SSC (N = 48) and standard care (N = 43) in preterm infants born at 32 to 36 weeks' gestation with birthweight between 1300 and 3000 g. No data on daily duration of KMC. Study did not report results for clinical outcomes
Arandia 1993Not a randomized controlled trial
Badiee 2014Study assessed effect of KMC (N = 25) vs standard care (N = 25) on mental health of mothers of LBW infants in the postpartum period. No data on neonatal morbidity and mortality
Bera 2014Not a randomized controlled trial
Bergman 1994Not a randomized controlled trial
Bergman 2004Study compared SSC (N = 21) from birth and standard care (N = 14) in LBW infants. Study period was 6 hours. Study reported results only for physiological parameters. Newborns receiving SSC from birth were significantly advantaged in some measures of cardiorespiratory stability
Broughton 2013Not a randomized controlled trial
Charpak 1994Not a randomized controlled trial
Chiu 2009Study compared early KMC (N = 52) and standard care (N = 48) in late preterm infants (32 to < 37 weeks' gestation). Study included infants with birthweight ≥ 2500 g. No data for subgroup of infants < 2500 g at birth. KMC infants had lower infant teaching scores at 6 months than controls - a difference that disappeared thereafter. Feeding scores at 6 and 12 months' follow-up were similar for KMC infants and controls
Christensson 1998Study compared SSC and incubator care for rewarming in 80 low-risk hypothermic infants (clinically stable with admission weight ≥ 1500 g)
Chwo 2002Study compared SSC (N = 17) and standard contact (N = 17) in infants born at 34 to 36 weeks' gestation. 20 of 34 included infants (59%) had birthweight > 2500 g. No data for the remaining 14 LBW infants
Dala Sierra 1994Not a randomized controlled trial
Darmstadt 2006Study evaluated acceptance of KMC within a trial of impact of a package of essential newborn care
de Almeida 2010Not a randomized controlled trial
de Macedo 2007Not a randomized controlled trial
Dehghani 2015Study compared SSC (N = 27) and standard care (N = 26) in infants hospitalized in the NICU, and reported results only for physiological parameters. Newborns receiving SSC had a significant increase in average temperature and arterial oxygen saturation rate
Feldman 2002Not a randomized controlled trial
Gregson 2011Not a randomized controlled trial
Hake Brooks 2008Study compared KMC (N = 36) and standard care (N = 30) in preterm infants. Study included infants with birthweight of 1300 to 3000 g. 39% of included infants had a gestational age of 36 weeks. No data for subgroup of infants < 2500 g at birth. KMC was associated with a significantly longer breastfeeding duration and a higher frequency of exclusive breastfeeding at discharge and at 1.5, 3, and 6 months
Huang 2006Study compared early KMC (N = 39) and use of radiant warmers (N = 39) in term infants with hypothermia problems. Mean (SD) birthweight was 3072 (393) and 2808 (428) g for KMC and control infants, respectively. After 4 hours, more infants in the KMC group had reached normal body temperature
Ibe 2004Not a randomized controlled trial
Kambarami 1998Quasi-random allocation to treatment (alternation). 74 (37 per group) infants were subjected to KMC or incubator care. Infants in the KMC group had higher mean daily weight gain, shorter stay in hospital, and better survival rates
Karimi 201472 infants born between 32 and 42 weeks' gestation were randomly assigned to KMC or routine care. Study included infants with birthweight > 2500 g and reported results only for breastfeeding self efficacy score at 3 months post partum. No data for subgroup of infants ≤ 2500 g at birth
Kashaninia 2015Not a randomized controlled trial
Kristoffersen 2016Not a randomized controlled trial
Kumar 2008Cluster-randomized controlled trial in which SSC was part of a preventive package of interventions for essential newborn care
Lai 2006Study compared music during KMC (N = 15) and standard care (N = 15) in preterm infants. Study included infants with birthweight of 1505 to 3285 g. No data for subgroup of infants < 2500 g at birth. In addition, the study did not report results for clinical outcomes
Lamy Filho 2008Not a randomized controlled trial
Lamy Filho 2015Study compared SSC (N = 53) and no intervention (N = 49) in LBW infants hospitalized in NICU whose nostrils were colonized with methicillin-oxacillin-resistant Staphylococcus aureus or methicillin-oxacillin-resistant coagulase-negative Staphylococcus aureus. Study reported results only for colonization status of newborns’ nostrils after 7 days of intervention
Legault 1993Participant allocation was by a cross-over recruitment design. Study did not report results for clinical outcomes
Legault 1995Not a randomized controlled trial
Lincetto 2000Not a randomized controlled trial
Lizarazo-Medina 2012Not a randomized controlled trial
Ludington-Hoe 1991Randomized controlled trial that compared KMC and standard care in cardiorespiratory, thermal, and state effects in preterm infants. No data on neonatal morbidity and mortality
Ludington-Hoe 2000Randomized controlled trial that compared KMC (N = 16) and standard care (N = 13) in maintenance of body warmth in preterm infants. No data on neonatal morbidity and mortality
Ludington-Hoe 2004Randomized controlled trial that compared KMC (N = 11) and standard care (N = 13) for assessment of cardiorespiratory and thermal responses in preterm infants. No data on neonatal morbidity and mortality
Ludington-Hoe 2006Randomized controlled trial that compared KMC (N = 14) and standard care (N = 14) for assessment of neonatal sleep organization in preterm infants. No data on neonatal morbidity and mortality
Lyngstad 2014Randomized controlled trial with a cross-over design (N = 19), which assessed SSC for reducing stress of preterm infants during diaper change
Miles 2006Study was a pragmatic, controlled trial in which participant allocation was by a cross-over, cluster recruitment design between 2 tertiary referral NICUs. Each hospital remained in KMC or control group for 4 months, then crossed over following a washout phase, during which no recruitment was undertaken. No significant difference was found in any infant or maternal measure at any time point
Miltersteiner 2005Quasi-random allocation to treatment (even or odd number). Length of hospital stay was 8 ± 1 days for the KMC group and 10 ± 1.9 days for the control group (P value = 0.004)
Mitchell 201338 infants (27 to 30 weeks' gestational age) were randomly assigned to 2 hours of KMC daily between days of life 5 and 10, or to standard incubator care. Study reported results only for physiological parameters. Infants allocated to KMC had significantly fewer events of bradycardia and oxygen desaturation than infants allocated to standard care
Mörelius 2015Study compared SSC (N = 18) and standard care (N = 19) in preterm infants (32 to 36 weeks' gestation). Study included infants with birthweight ≥ 2500 g. No data for subgroup of infants < 2500 g at birth. Overall, SSC decreased infants' cortisol reactivity in response to handling, improved concordance between mothers' and infants' salivary cortisol levels, and decreased fathers' experiences of spouse relationship problems
Ohgi 2002Not a randomized controlled trial
Samra 2015Randomized controlled trial that assessed effects of skin-to-skin holding (N = 20) versus blanket holding (N = 20) on stress of mothers of late preterm infants (34 to 36 weeks' gestation). Study included infants with birthweight ≥ 2500 g. No data for subgroup of infants < 2500 g at birth. Overall, no significant differences in stress scores between study groups
Silva 2016Not a randomized controlled trial
Sloan 2008Randomized controlled cluster trial in which 4165 infants were assigned to community-based KMC or control. 40% overall and 65% of newborns who died were not weighed at birth, and missing birthweight was differential for study group. 68.6% of weighed infants had a birthweight ≥ 2500 g. No difference in overall neonatal mortality rate nor infant mortality rate
Swarnkar 2016Quasi-random allocation (alternation) to KMC (N = 30) or conventional care (N = 30). Infants in KMC group had greater weight, length, and head circumference gain, and decreased risk of hypothermia compared with infants in the control group
Tallandini 2006Not a randomized controlled trial
Udani 2008Published as abstract only. Insufficient information to include this study in the systematic review, and unsuccessful attempts to locate full publication or to contact study author

Characteristics of studies awaiting assessment [ordered by study ID]

Holditch-Davis 2014

  1. a

    KMC = kangaroo mother care
    LBW = low birthweight
    SSC = skin-to-skin contact
    SGA = small for gestational age

MethodsRandomized controlled trial carried out in North Carolina and Illinois, United States
Participants

Number of infants: 162

Inclusion criteria: non-critically ill preterm infants with birthweight < 1750 g

Exclusion criteria: infants with congenital neurological problems (eg, congenital hydrocephalus, Down syndrome), mothers who had symptoms of substance exposure or who did not have custody of the infant or who had a risk factor that could affect their ability to administer the intervention (eg, age < 15 years; history of psychosis or bipolar disease; current diagnosis of major depression; non-English speaking); follow-up for 12 months unlikely

Infant stabilization status at trial entry: stabilized

Interventions

KMC group: Infants were kept in SSC in an upright position between the mother's breasts, dressed with a diaper and a hat. Mothers were instructed to perform the intervention at least once a day, 3 times a week, and for ≥ 15 minutes during infant hospitalization, and to continue at home until the infant was 2 months' corrected age (n = 81)

Control group: Mothers spent a similar amount of time each week as KMC mothers with the study nurse, discussing how to select and locate safe equipment needed to care for preterm infants at home, for example, clothes, diapers, formula, and toys. Holding was not part of the control group intervention (n = 81)

Level of care: initially at the NICU, then at home

Human resources: nurses

OutcomesMother-infant relationship, maternal psychological distress, social and home environment, mother's satisfaction
NotesThis study examined effects of KMC vs massage with auditory, tactile, visual, and vestibular (ATVV) stimulation vs an attention control group. If included in the review, we would exclude results of the ATVV intervention group

Ancillary