Alojamiento conjunto de la madre y al recién nacido versus atención separada para aumentar la duración de la lactancia materna
Resumen
Antecedentes
La proximidad e interacción entre la madre y el niño después del parto y durante el período inicial del posparto son importantes para la producción de leche materna y el éxito de la lactancia. El alojamiento conjunto y la atención separada son prácticas tradicionales. El alojamiento conjunto implica mantener a la madre y al recién nacido juntos en la misma habitación después del parto mientras dure la hospitalización, mientras que la atención separada consiste en mantener al recién nacido en la sala de recién nacidos del hospital y el recién nacido se le lleva a la madre para amamantarlo, o ella camina a la sala de recién nacidos.
Objetivos
Evaluar el efecto de la atención separada a la madre y el recién nacido versus el alojamiento conjunto sobre la duración de la lactancia materna (duración de la lactancia materna exclusiva y total).
Métodos de búsqueda
Se hicieron búsquedas en el registro de ensayos del Grupo Cochrane de Embarazo y Parto (Cochrane Pregnancy and Childbirth Group) (30 de mayo 2016) y en las listas de referencias de los estudios recuperados.
Criterios de selección
Ensayos controlados aleatorizados (ECA) o cuasialeatorizados que investigaron el efecto de la atención separada de la madre y el recién nacido versus el alojamiento conjunto después del parto en el hospital o en el domicilio sobre la duración de la lactancia materna, la proporción de la lactancia materna a los seis meses y los resultados adversos neonatales y maternos.
Obtención y análisis de los datos
Dos autores de la revisión de forma independiente evaluaron los estudios con respecto a su inclusión y su calidad. Dos autores de la revisión extrajeron los datos. Se verificó la exactitud de los datos. La calidad de la evidencia se evaluó mediante los criterios GRADE.
Resultados principales
La revisión incluyó un ensayo (con 176 pacientes mujeres). Este ensayo incluyó cuatro grupos con un diseño factorial. En el diseño factorial se tuvieron en cuenta dos factores, a saber, la ubicación del niño en relación con la madre y el tipo de ropa del niño. Tres de los grupos se combinaron como el grupo de intervención (alojamiento conjunto) y el cuarto grupo actuó como control (atención separada), y los resultados se analizaron como una comparación de pares únicos.
Resultados primarios
Los autores informaron el resultado primario, duración de cualquier lactancia como valores medianos porque se encontró que la distribución fue asimétrica. Informaron de que la duración media general de cualquier lactancia materna fue cuatro meses, sin diferencias entre los grupos. La duración de la lactancia materna exclusiva y la proporción de recién nacidos alimentados exclusivamente con leche materna a los seis meses de edad no se informó en el ensayo. No se encontraron diferencias entre los dos grupos en cuanto a la proporción de recién nacidos que recibían algún tipo de lactancia materna a los seis meses de edad (riesgo relativo [RR] 0,84; intervalo de confianza [IC] del 95%: 0,51 a 1,39; un ensayo; 137 mujeres; evidencia de calidad baja).
Resultados secundarios
La frecuencia media de la lactancia por día en el cuarto día posparto para el grupo de alojamiento conjunto fue 8,3 (desviación estándar [DE] 2,2), ligeramente superior a la del grupo de atención separada, es decir, siete veces al día. Sin embargo, la comparación entre los grupos para este resultado no fue apropiada, ya que cada niño en el grupo de atención separada recibió lactancia en un horario fijo de siete veces al día (DE = 0), lo que no permitió calcular una comparación. La tasa de lactancia materna exclusiva en el cuarto día posparto antes del alta hospitalaria fue significativamente más alta en el grupo de convivencia, 86% (99 de 115), en comparación con el grupo de atención separada, 45% (17 de 38), (RR 1,92; IC del 95%: 1,34 a 2,76; un ensayo, 153 mujeres; evidencia de calidad baja). No se informó sobre los otros resultados secundarios preestablecidos.
Conclusiones de los autores
Se encontró poca evidencia para apoyar o refutar la práctica de la atención separada de la madre y el recién nacido versus el alojamiento conjunto. Se necesitan más ECA bien diseñados para investigar el alojamiento conjunto completo de la madre y el niño en comparación con el alojamiento conjunto parcial o la atención separada, incluidos todos los resultados importantes.
PICO
Resumen en términos sencillos
Alojamiento conjunto de la madre y al recién nacido versus atención separada para aumentar la duración de la lactancia materna
¿Cuál es el problema?
Mantener a la madre y al recién nacido juntos (alojamiento conjunto) o separarlos después del parto son prácticas tradicionales que se observan en muchas culturas. A principios del siglo XX, cuando los hospitales se convirtieron en el centro de partos en los países industrializados, se estableció la práctica de la atención separada. Los recién nacidos se colocaban en una guardería separada de sus madres y solo se les llevaban a su madre para la lactancia. El alojamiento conjunto de madres e hijos se practica menos. La proximidad entre la madre y el recién nacido durante el primer período de posparto podría influir directamente en la interacción entre la madre y el recién nacido, y repercutir en la duración de la lactancia.
¿Por qué es esto importante?
La separación de los recién nacidos de sus madres después del parto puede reducir la frecuencia de la lactancia materna y la cantidad de leche materna que produce la madre. Sin embargo, los recién nacidos que permanecen junto con la madre durante toda la estancia hospitalaria recibirán lactancia con mayor frecuencia, lo que promovería la cercanía y el vínculo. La atención separada podría permitir a la madre descansar y reducir el estrés, lo que también podría mejorar la producción de leche. Actualmente muchos hospitales han comenzado a mantener a la madre y al recién nacido en la misma habitación, en particular desde el advenimiento de la Iniciativa Hospital Amigo del Recién Nacido de la OMS/UNICEF en 1991. Esta revisión sistemática intentó establecer a partir de los ensayos controlados aleatorizados si la atención por separado o el alojamiento conjunto de la madre y el recién nacido después del parto dieron lugar a una duración mayor de la lactancia materna exclusiva, una vez que habían vuelto a su hogar.
¿Qué evidencia se encontró?
La última búsqueda se realizó el 30 de mayo 2016. No se identificaron nuevos estudios. Solo se incluye un estudio en la revisión.
Se analizó un ensayo (en el que participaron 176 mujeres) que proporcionó información sobre la tasa de lactancia materna exclusiva al alta hospitalaria. Se encontró evidencia de calidad baja de que mantener a la madre y al recién nacido juntos en la misma habitación después del parto hasta que son dados de alta del hospital aumentó la tasa de lactancia materna exclusiva a los cuatro días del parto. No hubo diferencias entre los grupos en cuanto a la proporción de recién nacidos que recibían algún tipo de lactancia materna a los seis meses de edad.
¿Qué significa esto?
Se encontró poca evidencia para apoyar o refutar la práctica del alojamiento conjunto después del parto. Se necesita un ensayo controlado aleatorizado que informe de todos los resultados importantes, incluida la duración de la lactancia.
Authors' conclusions
Summary of findings
| Comparison between rooming‐in versus separate care for new mother and infant for increasing the duration of breastfeeding | ||||||
| Patient or population: 176 healthy mother‐infant dyads after normal spontaneous vaginal delivery (rooming‐in: 132, separate care: 44) Settings: 1 maternity home in St Petersburg, Russia Comparison: separate care | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect | No of Participants | Quality of the evidence | Comments | |
| Assumed risk | Corresponding risk | |||||
| Control | Comparison between rooming‐in versus separate care | |||||
| Duration of any breastfeeding | This outcome was reported as a median and could not be included in any analysis. | |||||
| Proportion of women exclusive breastfeeding at 6 months | The trial included in the review did not report this outcome. | |||||
| Proportion of women with any breastfeeding at 6 months (nearly exclusive breastfeeding) | Study population | RR 0.84 | 137 | ⊕⊕⊝⊝ | Althought there was no blinding of the intervention and blinding of the outcome assessor is unclear, we did not downgrade for lack of blinding because we judged this to be an objective outcome not affected by blinding | |
| 406 per 1000 | 341 per 1000 | |||||
| Frequency of breastfeeding per day | The mean frequency of breastfeeds per day on day 4 postpartum for the rooming‐in group was 8.3 (standard deviation (SD) 2.2), slightly higher than the separate care group, i.e. 7 times per day. However, analysis of this outcome was not possible since every infant in the separate care group was breastfed at a fixed schedule of 7 times per day (SD = 0) resulting in no estimable comparison. | |||||
| Exclusive breastfeeding at day 4 postpartum | Study population | RR 1.92 | 153 | ⊕⊕⊝⊝ | Although there was no blinding of the intervention and blinding of the outcome assessor is unclear, we did not downgrade for lack of blinding because we judged this to be an objective outcome not affected by blinding | |
| 447 per 1000 | 859 per 1000 | |||||
| Maternal level of confidence in breastfeeding | The trial included in the review did not report this outcome. | |||||
| Neonatal infection | The trial included in the review did not report this outcome. | |||||
| *The basis for the assumed risk (e.g. the 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). | ||||||
| GRADE Working Group grades of evidence | ||||||
| 1 Downgraded one level for risk of bias concerns due to differences in care between the groups other than the intervention and differences in the reason for attrition | ||||||
Background
Description of the condition
Keeping a mother and her baby together in the same room or separating them after birth are both traditional practices. However, in the early part of 20th century, when hospitals became the predominant sites for birth in industrialised countries, separation of mothers and babies became widely practised. Newborns were cared for in hospital nurseries and mothers in postnatal wards. Babies were brought to their mothers for feeding, but otherwise remained in the hospital nursery until discharge. More recently some hospitals have begun the practise of keeping the mother and infant together in the same room to promote breastfeeding. Mother‐infant proximity during the early postpartum period may influence mother‐infant behaviour that is essential in regulation of breast‐milk production and milk supply and hence it might make a difference to whether a mother successfully breastfeeds (Bramson 2010; Bigelow 2014; Moore 2012).
Description of the intervention
Keeping mother and infant together has been termed rooming‐in. It is defined by World Health Organization (WHO 1998), as the hospital practice where postnatal mothers with normal infants (including those born by caesarean section) stay together in the same room 24 hours a day, from the time they arrive in their room after delivery. They remain together until discharge unless there is a specific medical indication which warrants separation. During rooming‐in the infant is placed close to the mother either by bed‐sharing, an attached side‐car crib or by her bedside in a stand‐alone cot.
Separating the infant from the mother in the hospital nursery after birth allows the mother to sleep and rest. While she is recuperating, she can either walk to the nursery whenever she feels ready, as frequently as she wishes or she can request the infant to be brought to her room for demand breastfeeding. Alternatively, all babies are brought from the nursery to their mothers at fixed intervals usually of about three or four hours (Hiller 2006). In order to maintain optimal breast‐milk production, the mother may continue to stimulate her breasts in between breastfeeds by either milking the breasts by hand massage or using the mechanical pump to emulate the infant's suckling (Hill 1996). Separate care may also be partial, for example it could be practised during the night with rooming‐in during the day or rooming‐in during the hospitalisation and separate care at home after discharge or vice versa.
How the intervention might work
Placing the infant in close proximity to the mother enables the mother to respond in a timely way whenever her infant shows signs of readiness to feed. Uninhibited mother‐infant interaction and close contact promotes bonding, encourages demand breastfeeding and results in more efficient infant suckling, all essential in the regulation of breast‐milk secretion (Bigelow 2014). Observational studies suggest that rooming‐in is associated with higher a breastfeeding frequency (Yamauchi 1990), a higher rate of exclusive breastfeeding (Buranasin 1991) and a longer duration of breastfeeding (Wright 1996). Furthermore, mothers who remain together with their infants reported more self‐confidence and felt more competent in caring for their infants (O'Connor 1980), and were more likely to continue to breastfeed their infants longer than those mothers who had their infants separated. Apart from the positive effects on breastfeeding, rooming‐in mothers may have a lower incidence of breast engorgement and milk stasis (Wilde 1999) due to frequent breast‐suckling by the infant and better infant weight gain due to less energy consumption from crying during early infancy (Yamauchi 1990). Rooming‐in may also be advantageous to infant's health as it is associated with lower incidence of neonatal diarrhoea (Mustajab 1986) and significant hyperbilirubinaemia (Suradi 1998) when compared to the infants in nursery care.
On the other hand, separate care might be harmful because the process of breast‐milk production begins immediately after parturition with secretion of copious breast milk in the first 24 to 36 hours, progressing to mature breast milk by 72 hours postpartum (Neville 2001). The regulation of breast‐milk production during this period is controlled by multiple factors including the maternal physical and psychological condition, the frequency of breastfeeding and effective infant suckling (Knight 1998; Neville 1988). Previous research has demonstrated that higher breastfeeding frequency during the early days of the puerperium contributes to optimal milk production (Daly 1993), higher milk volume (Wilde 1995), and an adequate milk supply for a longer period (Hill 2005) and thus, likely to result in an increase in the duration of breastfeeding. On the contrary, lack or delay in breast stimulation in the first few days after delivery may result in sub‐optimal breast‐milk production, low milk supply and early cessation of breastfeeding (Bigelow 2012; Neville 1988 ). In addition, breast milk expression when compared to direct breastfeeding is associated with a higher risk of mastitis (Potter 2005). One study suggested that mother‐infant separation in the early days of puerperium negatively affects the breast‐milk production and reduces the duration of breastfeeding (Elander 1984), but there are other studies that show maternal intention and interest in breastfeeding is the most important determining factor that influences the success of breastfeeding (Bergman 2013; Forster 2006; Lee 2007).
There is a perceived security concern for infants when other patients and visitors have access to them, especially in hospitals with open maternity wards. In the hospital nursery, there is tighter security as access to the infants is strictly limited to mothers and midwives and in some hospitals even mothers are not allowed into the nursery. One of the reasons for the practice of separate care was the belief that it would protect babies from infection. However, serious outbreaks of nursery infection were reported leading to a proposal that keeping the mother and baby together might prevent infections (Hiller 2006).
Labour is a stressful event for both the mother and infant. Most mothers, especially primigravidas and mothers who have had caesarean birth or prolonged and complicated labour, require adequate rest after childbirth in order to recover physically and psychologically. Increased levels of stress hormones during childbirth have been shown to affect the onset of breast‐milk production leading to early breastfeeding failure (Chen 1998), and this could be potentially reduced by separate care.
Why it is important to do this review
The duration of exclusive breastfeeding globally remains low, with only an estimated 35% of infants being exclusively breastfed up to four months of age (WHO 2012), despite the benefits of breastfeeding for six months being well‐established (Kramer 2012; Victora 1987). Among the factors in the early puerperium that contribute to failure to sustain lactation for a longer duration include the mother's condition after labour, psychological stress (Chen 1998), mode of delivery (Suradi 1998), individual cultural practice (Ingram 2003) and, most importantly, the maternal desire to breastfeed her infant.
Mother‐infant rooming‐in is recommended by WHO/UNICEF Baby Friendly Hospital Initiative 1991 in the 10 steps to successful breastfeeding. It is believed to be the most favourable arrangement for optimal breast‐milk production (WHO 1998). Although both separate care and rooming‐in are traditional practices, the benefits and harms have not been fully evaluated. Therefore, the aim of this review is to assess the effects of the practice of routine mother‐infant rooming‐in compared with the practice of routine separation of mothers and babies on the duration of breastfeeding.
Objectives
To assess the effect of mother‐infant rooming‐in versus separation on the duration of breastfeeding (exclusive and total duration of breastfeeding).
Methods
Criteria for considering studies for this review
Types of studies
Randomised or quasi‐randomised controlled trials including cluster‐randomised trials were eligible for inclusion.
Types of participants
All mothers who have given birth and are able to care for their normal newborn infants whether or not they have initiated breastfeeding. Trials recruiting populations with specific health problems such as AIDS were not included in this review.
Types of interventions
For this update we have reversed the intervention and the comparison. We have taken rooming‐in as our intervention and separate care as the comparison (seeDifferences between protocol and review). Since both rooming‐in and separate care are traditional practices we have made this change because we felt that rooming‐in was the intervention of interest and it was more intuitive for the reader.
Intervention
Mother and infant placed in the same room immediately after birth in the case of a home birth, immediately after leaving the labour or delivery room after a normal hospital birth or from the time when the mother is able to respond to her infant (in the case of caesarean section) where the infant is either bed‐sharing by attached side‐car crib or placed in a stand‐alone cot by the bedside.
Comparison
Mother and infant are placed separately. The primary site of care of the infant is in the hospital nursery throughout the hospital stay or, in the case of deliveries at home, the infant is cared for in a separate room by someone other than the mother.
Types of outcome measures
Primary outcomes
Duration of breastfeeding as measured by one of the following.
-
Duration of exclusive breastfeeding.
-
Duration of any breastfeeding.
-
Proportion of infants being exclusively breastfed at six months of age.
-
Proportion of infants being given any breastfeeding at six months of age (not pre‐specified).
-
Exclusive breastfeeding is defined as an infant receiving only breast milk, without any additional food or supplement.
-
Any breastfeeding is defined as an infant receiving any amount of breast milk, regardless of supplements.
Secondary outcomes
-
Frequency of breastfeeding per day.
-
Exclusive breastfeeding on discharge from the hospital or day four postpartum.
-
Maternal outcomes: breast engorgement, maternal duration of sleep, maternal adverse events (wound breakdown, puerperal sepsis, fainting episode, postpartum haemorrhage), maternal satisfaction and level of mother's confidence in breastfeeding.
-
Neonatal outcomes: any neonatal infection, diarrhoea, hypoglycaemia, hypothermia, significant hyperbilirubinaemia needing therapy.
Search methods for identification of studies
The following methods section of this review is based on a standard template used by the Cochrane Pregnancy and Childbirth Group.
Electronic searches
We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register by contacting their Information Specialist (30 May 2016).
The Register is a database containing over 22,000 reports of controlled trials in the field of pregnancy and childbirth. For full search methods used to populate the Pregnancy and Childbirth Group’s Trials Register including the detailed search strategies for CENTRAL, MEDLINE, Embase and CINAHL; the list of handsearched journals and conference proceedings, and the list of journals reviewed via the current awareness service, please follow this link to the editorial information about the Cochrane Pregnancy and Childbirth Group in the Cochrane Library and select the ‘Specialized Register ’ section from the options on the left side of the screen.
Briefly, the Cochrane Pregnancy and Childbirth Group’s Trials Register is maintained by their Information Specialist and contains trials identified from:
-
monthly searches of the Cochrane Central Register of Controlled Trials (CENTRAL);
-
weekly searches of MEDLINE (Ovid);
-
weekly searches of Embase (Ovid);
-
monthly searches of CINAHL (EBSCO);
-
handsearches of 30 journals and the proceedings of major conferences;
-
weekly current awareness alerts for a further 44 journals plus monthly BioMed Central email alerts.
Search results are screened by two people and the full text of all relevant trial reports identified through the searching activities described above is reviewed. Based on the intervention described, each trial report is assigned a number that corresponds to a specific Pregnancy and Childbirth Group review topic (or topics), and is then added to the Register. The Information Specialist searches the Register for each review using this topic number rather than keywords. This results in a more specific search set which has been fully accounted for in the relevant review sections: (Included studies; Excluded studies; Studies awaiting classification).
Searching other resources
We searched the reference lists of retrieved studies.
We did not apply any language or date restrictions.
Data collection and analysis
For methods used in the previous version of this review, seeJaafar 2012.
For this update, we planned to use the following methods to assess the reports identified as a result of the updated search. However, no new studies were included in this update.
The following methods section of this review is based on a standard template used by the Cochrane Pregnancy and Childbirth Group.
Selection of studies
Two review authors independently assessed for inclusion the potential studies identified as a result of the search strategy. We resolved any disagreement through discussion or, if required, we consulted the third review author.
Data extraction and management
We designed a form to extract data. For the one eligible study, two review authors extracted the data using the agreed form. We resolved discrepancies through discussion or, if required, we consulted the third review author. Data were entered into Review Manager software (RevMan 2014) and checked for accuracy.
When information regarding any of the above was unclear, we planned to contact authors of the original reports to provide further details.
Assessment of risk of bias in included studies
In the previous version of this review, two review authors independently assessed risk of bias for the included study using the criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011) and outlined below. Any disagreement was resolved by discussion or by involving a third assessor.
(1) Random sequence generation (checking for possible selection bias)
We described for the one included study the method used to generate the allocation sequence in sufficient detail to allow an assessment of whether it should produce comparable groups.
We assessed the method as:
-
low risk of bias (any truly random process, e.g. random number table; computer random number generator);
-
high risk of bias (any non‐random process, e.g. odd or even date of birth; hospital or clinic record number);
-
unclear risk of bias.
(2) Allocation concealment (checking for possible selection bias)
We described for the included study the method used to conceal allocation to interventions prior to assignment and assessed whether intervention allocation could have been foreseen in advance of, or during recruitment, or changed after assignment.
We assessed the methods as:
-
low risk of bias (e.g. telephone or central randomisation; consecutively numbered sealed opaque envelopes);
-
high risk of bias (open random allocation; unsealed or non‐opaque envelopes, alternation; date of birth);
-
unclear risk of bias.
(3.1) Blinding of participants and personnel (checking for possible performance bias)
We described for the included study the methods used, if any, to blind study participants and personnel from knowledge of which intervention a participant received. We had determined that studies would be at low risk of bias if they were blinded, or if we judged that the lack of blinding unlikely to affect results. We assessed blinding separately for different outcomes or classes of outcomes.
We assessed the methods as:
-
low, high or unclear risk of bias for participants;
-
low, high or unclear risk of bias for personnel.
(3.2) Blinding of outcome assessment (checking for possible detection bias)
We described for the included study the methods used, if any, to blind outcome assessors from knowledge of which intervention a participant received. We assessed blinding separately for different outcomes or classes of outcomes.
We assessed methods used to blind outcome assessment as:
-
low, high or unclear risk of bias.
(4) Incomplete outcome data (checking for possible attrition bias due to the amount, nature and handling of incomplete outcome data)
We described for the included study, and for each outcome or class of outcomes, the completeness of data including attrition and exclusions from the analysis. We stated whether attrition and exclusions were reported and the numbers included in the analysis at each stage (compared with the total randomised participants), reasons for attrition or exclusion where reported, and whether missing data were balanced across groups or were related to outcomes. Where sufficient information was reported, or could be supplied by the trial authors, we planned to re‐include missing data in the analyses which we undertook.
We assessed methods as:
-
low risk of bias (e.g. no missing outcome data; missing outcome data balanced across groups);
-
high risk of bias (e.g. numbers or reasons for missing data imbalanced across groups; ‘as treated’ analysis done with substantial departure of intervention received from that assigned at randomisation);
-
unclear risk of bias.
(5) Selective reporting (checking for reporting bias)
We described for the included study how we investigated the possibility of selective outcome reporting bias and what we found.
We assessed the methods as:
-
low risk of bias (where it is clear that all of the study’s pre‐specified outcomes and all expected outcomes of interest to the review have been reported);
-
high risk of bias (where not all the study’s pre‐specified outcomes have been reported; one or more reported primary outcomes were not pre‐specified; outcomes of interest are reported incompletely and so cannot be used; study fails to include results of a key outcome that would have been expected to have been reported);
-
unclear risk of bias.
(6) Other bias (checking for bias due to problems not covered by (1) to (5) above)
We described for the included study any important concerns we had about other possible sources of bias.
(7) Overall risk of bias
We made explicit judgements about whether the one included study was at high risk of bias, according to the criteria given in the Handbook (Higgins 2011). With reference to (1) to (6) above, we assessed the likely magnitude and direction of the bias and whether we considered it is likely to impact on the findings. In future updates, we will explore the impact of the level of bias through undertaking sensitivity analyses ‐ seeSensitivity analysis.
Assessment of the quality of the evidence using the GRADE approach
For this update the quality of the evidence was assessed using the GRADE approach as outlined in the GRADE handbook in order to assess the quality of the body of evidence relating to the following outcomes for the main comparison.
-
Duration of any breastfeeding
-
Proportion of infants being exclusively breastfed at six month of age
-
Proportion of infants being given any breastfeeding at six months of age
-
Frequency of breastfeeding per day
-
Exclusive breastfeeding on discharge from the hospital or day four postpartum.
-
Maternal level of confidence in breastfeeding
-
Neonatal infection
We used GRADEpro Guideline Development Tool to import data from Review Manager 5.3 (RevMan 2014) in order to create a ’Summary of findings’ table. A summary of the intervention effect and a measure of quality for each of the above outcomes were produced using the GRADE approach. The GRADE approach uses five considerations (study limitations, consistency of effect, imprecision, indirectness and publication bias) to assess the quality of the body of evidence for each outcome. The evidence can be downgraded from 'high quality' by one level for serious (or by two levels for very serious) limitations, depending on assessments for risk of bias, indirectness of evidence, serious inconsistency, imprecision of effect estimates or potential publication bias.
Measures of treatment effect
Dichotomous data
For dichotomous data, we presented results as summary risk ratio (RR) with 95% confidence intervals.
Continuous data
Had we had encountered continuous outcomes, we planned to report the mean difference if outcomes were measured in the same way between trials. We would have used the standardised mean difference to combine trials that measured the same outcome, but used different methods.
Unit of analysis issues
Cluster‐randomised trials
We did not identify any cluster‐randomised trials for inclusion in this update. In future updates, if eligible for inclusion, we will include cluster‐randomised trials in the analyses along with individually‐randomised trials if such trials are identified and are otherwise eligible. We will adjust their sample sizes using the methods described in the Handbook using an estimate of the intracluster correlation co‐efficient (ICC) derived from the trial (if possible), from a similar trial or from a study of a similar population. If we use ICCs from other sources, we will report this and conduct sensitivity analyses to investigate the effect of variation in the ICC. If we identify both cluster‐randomised trials and individually‐randomised trials, we plan to synthesise the relevant information. We will consider it reasonable to combine the results from both if there is little heterogeneity between the study designs and the interaction between the effect of intervention and the choice of randomisation unit is considered to be unlikely.
We will also acknowledge heterogeneity in the randomisation unit and perform a subgroup analysis to investigate the effects of the randomisation unit.
Cross‐over trials
Cross‐over trials are not eligible for inclusion; such trials are not appropriate for this type of intervention.
Trials with more than two arms
The trial included in this review consisted of four groups. We combined three of the groups as the intervention (rooming‐in) and the fourth group acted as the control (separate care) and analysed the results as a single pair‐wise comparison using the methods set out in the Handbook (Higgins 2011) to avoid double‐counting.
Dealing with missing data
We noted the level of attrition for the one included study. In future updates, if more eligible studies are included, the impact of including studies with high levels of missing data in the overall assessment of treatment effect will be explored by using sensitivity analysis.
For all outcomes, analyses were carried out, as far as possible, on an intention‐to‐treat basis, i.e. we attempted to include all participants randomised to each group in the analyses. The denominator for each outcome in each trial was the number randomised minus any participants whose outcomes were known to be missing.
Assessment of heterogeneity
There was only one included study in this update and so it was not possible to assess heterogeneity. In future updates, we will assess statistical heterogeneity in each meta‐analysis using the Tau², I² and Chi² statistics. We will regard heterogeneity as substantial if the I² is greater than 30% and either the Tau² is greater than zero, or there is a low P value (less than 0.10) in the Chi² test for heterogeneity.
Assessment of reporting biases
In future updates, if there are 10 or more studies in the meta‐analysis, we will investigate reporting biases (such as publication bias) using funnel plots. We will assess funnel plot asymmetry visually. If asymmetry is suggested by a visual assessment, we will perform exploratory analyses to investigate it.
Data synthesis
We carried out statistical analysis using the Review Manager software (RevMan 2014). There was only one included study in this update. In future updates, if more studies are included, we will use fixed‐effect meta‐analysis for combining data where it is reasonable to assume that studies are estimating the same underlying treatment effect: i.e. where trials are examining the same intervention, and the trials’ populations and methods are judged sufficiently similar. If there is clinical heterogeneity sufficient to expect that the underlying treatment effects differ between trials, or if substantial statistical heterogeneity is detected, we will use random‐effects meta‐analysis to produce an overall summary, if an average treatment effect across trials is considered clinically meaningful. The random‐effects summary will be treated as the average of the range of possible treatment effects and we will discuss the clinical implications of treatment effects differing between trials. If the average treatment effect is not clinically meaningful, we will not combine trials.
If we use random‐effects analyses, the results will be presented as the average treatment effect with 95% confidence intervals, and the estimates of Tau² and I².
Subgroup analysis and investigation of heterogeneity
There was only one included study and so it was not possible to carry out planned subgroup analysis. In future updates, if we identify substantial heterogeneity, we will investigate it using subgroup analyses and sensitivity analyses. We will consider whether an overall summary is meaningful, and if it is, use random‐effects analysis to produce it.
We will carry out the following subgroup analyses to compare the differential effect of the intervention by mode of delivery (normal delivery versus caesarean section), by parity (primipara versus multipara) and by the infant sleeping allocation (bed‐sharing versus bedside cot). For this update we have added feeding schedule.
In future updates any subgroup analyses will be restricted to the primary outcomes:
-
duration of exclusive breastfeeding;
-
duration of any breastfeeding;
-
proportion of infants exclusively breastfed at six months of age.
We will assess subgroup differences by interaction tests available within RevMan (RevMan 2014) and report the results quoting the Chi² statistic and P value, and the interaction test I² value.
Sensitivity analysis
In future updates of this review, as more data become available, we will carry out sensitivity analysis to explore the effect of trial quality. This will involve analyses excluding studies at risk of selection bias or attrition bias. Studies of poor quality (rated as 'inadequate' or 'unclear' for allocation concealment; sequence generation; or incomplete outcome assessment), will in future updates be excluded from the analysis in order to assess for any substantive difference to the overall result.
Results
Description of studies
Results of the search
For the previous version of this review (Jaafar 2012), the search identified 24 reports of 19 randomised controlled trials (RCTs). We included one study (four reports) (Bystrova 2008).
For this 2016 update, we identified two new trial reports, one of which is a further report of Bystrova 2008. The other report (Tateoka 2014), is in abstract form only and does not provide sufficient information to include or exclude (seeStudies awaiting classification for details). We previously referenced two reports of an excluded study (O'Connor 1980) as two separate studies and have now merged these into one.
Included studies
One trial met our inclusion criteria. This study was reported as a thesis and in four study reports. Two of these reports contributed data for analysis.
Bystrova 2008: The study was a 4 x 2 factorial design involving a total of 176 mothers who were randomly assigned to the four main treatment groups. The four treatment groups were 1) skin‐to‐skin contact at birth with rooming‐in, 2) no skin‐to‐skin contact with rooming‐in, 3) no skin‐to‐skin contact with 24 hours nursery care, and 4) no skin‐to‐skin contact with rooming‐in delayed up to three hours after birth. The overall aim of the study was to explore the role of closeness versus separation on infant and maternal outcomes, including breastfeeding outcomes. Breastfeeding outcomes on day four postpartum were reported in one of the reports. The authors reported the overall duration of 'nearly exclusive' breastfeeding as a median. In this review, we included the reported 'nearly exclusive' breastfeeding outcome as our pre‐specified outcome 'any breastfeeding'. Data for nearly exclusive breastfeeding at six months was provided by the author. We reported this as one of our primary outcome of 'any breastfeeding'.
Three reports from Bystrova 2008 reported the effect of maternity home practices on breastfeeding performance with special reference to the type of infant apparel and the long‐term effect of early contact versus separation. The most recent study report identified for this 2016 update reported on mother‐infant interactions at day four postpartum by video analysis lasting 25 to 45 minutes. Videos were analysed for their visual content using a validated assessment tool (Assessment tool for the observation of mother/infant interaction, (unpublished)) to evaluate the quality of four variables measuring aspects of mother‐infant interactions, each on a scale of one to five. Video data were available for analysis only for 151 mother‐infant dyads. Some of these observations might indirectly measure maternal confidence. However, there were no analysable data; only P values were reported.
For further details of the trial, seeCharacteristics of included studies.
Excluded studies
A total of 18 trials (20 reports) were excluded. Perez‐Escamilla 1992: this trial met our objective of comparing separate care with rooming and reported our pre‐specified outcome rate of breastfeeding at discharge, eight, 70 and 135 days postpartum. However, this study was excluded because the participating mothers were not randomly assigned to separate care or rooming. There were two other non‐randomised controlled trials and neither of these met our inclusion criteria for the intervention (Elander 1986; Kontos 1978). The other 15 trials were excluded because the intervention did not meet our inclusion criteria.
For further details of the excluded studies, seeCharacteristics of excluded studies.
One study identified at this update (Tateoka 2014) was only in abstract form and there were insufficient data available to make a judgement as to whether this study met our inclusion criteria. The authors have been contacted for further information. We are waiting for a response. For details, see Characteristics of studies awaiting classification.
Risk of bias in included studies
See Figure 1 for a summary of our 'Risk of bias' assessments.
'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
Allocation
For Bystrova 2008, we judged the risk of selection bias to be low as they used a table to generate a random sequence and sequentially numbered opaque sealed envelopes to achieve allocation concealment.
Blinding
The authors stated that the women and researchers were blinded to the task. We judged this to be unclear. However blinding of the intervention and comparison would be extremely difficult if not impossible to achieve.
Incomplete outcome data
A total of 23 (13%) mothers were excluded from the in‐hospital analysis and the reasons for exclusion were similar across the four groups. However a total of five out of 44 (11%) dropped out after allocation because they did not want to be allocated to nursery care, and six out of 115 (5%) because they did not want rooming‐in. We judged there to be an imbalance between the groups for the reasons of attrition. There were no significant differences between the 23 mothers who were excluded and the 153 mothers who participated in the study with respect to education or the other background variables. Data were available for 78% of mothers at six‐month follow‐up. Intention‐to‐treat principle was used for those women who remained in the study.
Selective reporting
We judged this to be unclear because in the methods section of the thesis it was stated that breastfeeding duration was up to 12 months, however the results were not reported in any of the study publications, whereas other outcomes not relevant to this review were reported up to 12 months. Three‐ and six‐month data were provided on request.
Other potential sources of bias
One‐third of the women in the rooming‐in group were allocated to skin‐to‐skin contact and one‐third were able to hold their fully‐clothed infant in the labour ward after birth, whereas one‐third of the rooming‐in group and all of the separate care group did not have any contact with their infant in the labour ward. These factors could independently influence breastfeeding outcomes, apart from any intervention effect, and so we judged this to be high risk for other biases.
Effects of interventions
Comparison: Rooming‐in versus separate mother and infant care after birth
Primary outcomes
Only one randomised trial (Bystrova 2008), involving 176 women, contributed data to the outcomes of interest, i.e. duration of any breastfeeding, frequency of breastfeeding per day and the rate of infants exclusively breastfed on discharge from the hospital. However, the trial did not report the duration of exclusive breastfeeding; the proportion of infants exclusively breastfed up to six months of age; or any of the maternal or neonatal outcomes pre‐specified in our protocol.
Duration of any breastfeeding
The overall median duration of any breastfeeding was reported to be four months. The authors stated that there was no significant difference between the groups. These data were reported as median because the distribution was skewed and so we could not include the data in any analysis.
Proportion of infants being given any breastfeeding at six months of age (not pre‐specified)
There was no difference between the rooming‐in (36/105) and separate care (13/32) in the proportion of infants receiving any breastfeeding at six months (risk ratio (RR) 0.84, 95% confidence interval (CI) 0.51 to 1.39; one trial; 137 women; low‐quality evidence), (Analysis 1.1).
Secondary outcomes
Frequency of breastfeeding per day
The Brystrova trial reported the mean frequency of breastfeeds per day on day four postpartum for the rooming‐in group as 8.3 (standard deviation (SD) 2.2), slightly higher that the separate care group, i.e. seven times per day. However, analysis of this outcome was not done since every infant in the separate care group was breastfed at a fixed schedule of seven times per day (SD = 0) resulting in no estimable comparison.
Exclusive breastfeeding at day four postpartum
The rate of infants exclusively breastfed on day four postpartum before discharge from hospital was significantly higher in the rooming‐in group 86% (99/115) compared with separate care group, 45% (17/38) (RR 1.92; 95% CI 1.34 to 2.76; one trial, 153 women; low‐quality evidence), (Analysis 1.3).
None of our other pre‐specified secondary outcomes were reported.
Subgroup analysis
We did not have sufficient data to perform any of our pre‐specified subgroup analyses.
However, one‐third of the women in the rooming‐in group were allocated to skin‐to‐ skin contact and one‐third were able to hold their fully clothed infant in the labour ward after birth, whereas one‐third of the rooming‐in group and all of the separate care group did not have any contact with their infant in the labour ward. These factors could independently influence breastfeeding outcomes, apart from any intervention effect, and so we judged this to be high risk for other biases. We conducted a posthoc subgroup analysis to explore the impact of the differences in labour ward management and found no differences between the three rooming‐in groups subgroups, (Analysis 1.2).
Discussion
Summary of main results
We found only one randomised controlled trial (RCT) (involving 176 mother‐infant dyads) which took place in one maternity home in St Petersburg, Russia for inclusion in the review. Analysis from the available data showed mother‐infant rooming‐in significantly increased the rate of exclusive breastfeeding at discharge (day four postpartum). However, there is insufficient evidence to draw any conclusion on the effect of this on breastfeeding duration up to six months.
Overall completeness and applicability of evidence
The search for studies for inclusion in this review was very extensive and we believe that there is only one study that addresses our question. The included RCT (Bystrova 2008) did not evaluate all the important pre‐specified outcomes, in particular it did not evaluate the proportion of infants exclusively breastfed up to six months of age as recommended by the World Health Organization. The trial examined only healthy mother‐infant pairs after a normal vaginal delivery and did not include healthy mother‐infant pairs after operative delivery as we had intended to study. In addition, they did not report any of our pre‐specified potentially harmful maternal and fetal outcomes such as rate of breast engorgement, maternal adverse events, neonatal infection, diarrhoea, and hypoglycaemia.
Quality of the evidence
The quality of the evidence is severely limited by the inclusion of only one small study. We were unable to conduct GRADE quality assessments on five of our seven GRADE outcomes (duration of any breastfeeding; proportion of infants being exclusively breastfed at six month of age; frequency of breastfeeding per day; maternal level of confidence in breastfeeding; neonatal infection). The study reported nearly exclusive breastfeeding at six months. We judged this to be similar enough to our outcome, any breastfeeding. The authors stated that exclusive breastfeeding was rare in their setting. Nearly exclusive breastfeeding was defined as breastfeeding plus irregular supplementation of juices and solids less than 30 mL per day and formula less than 100 mL per day. We assessed the two outcomes proportion of women with any breastfeeding at six months (nearly exclusive breastfeeding) and exclusive breastfeeding at day four postpartum as being of low‐quality evidence. We downgraded both outcomes to low quality because the evidence was derived only from this one small study, and secondly for risk of bias. We judged the study to be at high risk of attrition bias and for other biases arising from differences in labour ward management between the groups. These differences could have had an independent effect on our pre‐specified outcomes. However, we conducted a posthoc subgroup analysis to explore the impact of the differences in labour ward management. We found no differences between the three rooming‐in groups subgroups.
Potential biases in the review process
We attempted to minimise bias during the review process by having two people assess the eligibility of studies, assess risk of bias and extract data with a third person involved to check or review each area. We attempted to be as inclusive as possible in our search. We introduced the outcome proportion of infants being fed any breastfeeding at six months for this update. This is a post hoc decision which we made after we had completed our search and the decision is partly based on the outcomes reported in the included trial but also based om outcomes reported in the other Cochrane reviews reporting duration of breastfeeding.
Agreements and disagreements with other studies or reviews
We did not find any other review on this topic. A non‐randomised study (Perez‐Escamilla 1992) found a higher rate of breastfeeding at four months for primiparous but not multiparous women who received rooming‐in but not separate care.
'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
Comparison 1 Comparison between rooming‐in versus separate care, Outcome 1 Proportion of women with any breastfeeding at 6 months.
Comparison 1 Comparison between rooming‐in versus separate care, Outcome 2 Proportion of women with any breastfeeding at 6 months by subgroups for delivery room management.
Comparison 1 Comparison between rooming‐in versus separate care, Outcome 3 Exclusive breastfeeding at day 4 postpartum.
| Comparison between rooming‐in versus separate care for new mother and infant for increasing the duration of breastfeeding | ||||||
| Patient or population: 176 healthy mother‐infant dyads after normal spontaneous vaginal delivery (rooming‐in: 132, separate care: 44) Settings: 1 maternity home in St Petersburg, Russia Comparison: separate care | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect | No of Participants | Quality of the evidence | Comments | |
| Assumed risk | Corresponding risk | |||||
| Control | Comparison between rooming‐in versus separate care | |||||
| Duration of any breastfeeding | This outcome was reported as a median and could not be included in any analysis. | |||||
| Proportion of women exclusive breastfeeding at 6 months | The trial included in the review did not report this outcome. | |||||
| Proportion of women with any breastfeeding at 6 months (nearly exclusive breastfeeding) | Study population | RR 0.84 | 137 | ⊕⊕⊝⊝ | Althought there was no blinding of the intervention and blinding of the outcome assessor is unclear, we did not downgrade for lack of blinding because we judged this to be an objective outcome not affected by blinding | |
| 406 per 1000 | 341 per 1000 | |||||
| Frequency of breastfeeding per day | The mean frequency of breastfeeds per day on day 4 postpartum for the rooming‐in group was 8.3 (standard deviation (SD) 2.2), slightly higher than the separate care group, i.e. 7 times per day. However, analysis of this outcome was not possible since every infant in the separate care group was breastfed at a fixed schedule of 7 times per day (SD = 0) resulting in no estimable comparison. | |||||
| Exclusive breastfeeding at day 4 postpartum | Study population | RR 1.92 | 153 | ⊕⊕⊝⊝ | Although there was no blinding of the intervention and blinding of the outcome assessor is unclear, we did not downgrade for lack of blinding because we judged this to be an objective outcome not affected by blinding | |
| 447 per 1000 | 859 per 1000 | |||||
| Maternal level of confidence in breastfeeding | The trial included in the review did not report this outcome. | |||||
| Neonatal infection | The trial included in the review did not report this outcome. | |||||
| *The basis for the assumed risk (e.g. the 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). | ||||||
| GRADE Working Group grades of evidence | ||||||
| 1 Downgraded one level for risk of bias concerns due to differences in care between the groups other than the intervention and differences in the reason for attrition | ||||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Proportion of women with any breastfeeding at 6 months Show forest plot | 1 | 137 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.84 [0.51, 1.39] |
| 2 Proportion of women with any breastfeeding at 6 months by subgroups for delivery room management Show forest plot | 1 | Risk Ratio (M‐H, Fixed, 95% CI) | Subtotals only | |
| 2.1 Skin‐to‐skin | 1 | 67 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.98 [0.55, 1.76] |
| 2.2 Held in mothers arms | 1 | 70 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.58 [0.29, 1.18] |
| 2.3 Separate delivery room care | 1 | 68 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.89 [0.49, 1.63] |
| 3 Exclusive breastfeeding at day 4 postpartum Show forest plot | 1 | 153 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.92 [1.34, 2.76] |
