Lactancia materna para el dolor durante los procedimientos en lactantes más allá del período neonatal
Referencias
Referencias de los estudios incluidos en esta revisión
Referencias de los estudios excluidos de esta revisión
Referencias de los estudios en curso
Referencias adicionales
Characteristics of studies
Characteristics of included studies [ordered by study ID]
| Study characteristics | ||
| Methods | Randomised controlled trial at 2 community health clinics in Quebec, Canada | |
| Participants | Longitudinal study ‐ enrolling infants at 2 & 4 months vaccination. 96 infants age 2 months, randomised to intervention or control. 64 infants remained in study at 4 months and remained in the intervention or control group to which they were initially assigned. 2 additional infants were included at 4 months, and randomised. Painful procedure: DPT vaccination Study period: Not specified | |
| Interventions | Intervention: Breastfeeding before, during, and after vaccination Control: Maternal holding during vaccination | |
| Outcomes | Percentage of time crying at baseline, during vaccination, and after vaccination NFCS at baseline, during vaccination, and after vaccination Facial flushing at baseline, during vaccination, and after vaccination Salivary cortisol at baseline and 25 minutes after vaccination | |
| Notes | Power calculation: Yes (p. 9) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "96 infants were randomised at 2 months of age, in blocks of eight to 'breastfeeding' (intervention) or 'non‐breastfeeding' (control) groups." (p. 9) |
| Allocation concealment (selection bias) | Unclear risk | "96 infants were randomised in blocks of eight to 'breastfeeding' (intervention) or 'non‐breastfeeding' (control) groups." (p. 9) Not enough information to assess how allocation was concealed. |
| Blinding of participants and personnel (performance bias) | High risk | "Mothers whose infants were assigned to the breastfeeding condition were then asked to start breastfeeding 3 minutes before the injection and to continue breast feeding during and after the injection." (p. 10) Personnel could not be blinded to whether infant was breastfeeding or not. |
| Blinding of outcome assessment (detection bias) | High risk | "Audiotaping and videotaping started 3 minutes before the injection and continued for 3 minutes after the injection." (p. 10) The researcher completing the NFCS scores could not be blinded to whether the infant was breastfeeding. |
| Incomplete outcome data (attrition bias) | Low risk | Participant flow chart presented (p. 23). Data analysed for 89 out of 96 infants at 2 months and 61 out of 66 infants at 4 months (due to technical difficulties, physical illness, no demographic information, not breastfeeding, or refusal). Less than 10% missing data. |
| Selective reporting (reporting bias) | Unclear risk | Study protocol not registered in trial registries searched. Study has not been published, however unpublished raw data were shared. |
| Sample size | High risk | Fewer than 50 infants per arm. |
| Other bias | Low risk | Appears free of other bias. |
| Study characteristics | ||
| Methods | Randomised controlled trial at a single site (healthcare centre) in Iran | |
| Participants | 144 infants ages 2 to 6 months Painful procedure: Hepatitis B and DPT vaccination Study period: 2009 | |
| Interventions | Intervention 1: Breastfeeding before and during vaccination Intervention 2: Vapocoolant before vaccination Control: No intervention | |
| Outcomes | NIPS score during vaccination (reported as pain if NIPS >3 and painless if NIPS =< 3) | |
| Notes | Power calculation: No | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "They were randomly divided into three groups of vapocoolant, breastfeeding, and control (48 subjects in each group) through systematic random sampling." (p. 3) Specific randomisation method not described. |
| Allocation concealment (selection bias) | Unclear risk | "They were randomly divided into three groups of vapocoolant, breastfeeding, and control (48 subjects in each group) through systematic random sampling." (p. 3) Not enough information to assess how allocation was concealed. |
| Blinding of participants and personnel (performance bias) | High risk | "If the infant was in breastfeeding group, vaccination was administrated after the researcher had observed continuous active sucking (infants’ intraoral form, raised cheeks, and active jaw movements). If the infant was in vapocoolant group, the injection site was sprayed from a distance of 15 cm for 13 s, and after evaporation (10 s later), the injection site was disinfected by alcohol and the vaccination administered. In the control group, injection was administered with no pain control intervention." (p. 4) Personnel could not be blinded to whether infant was breastfeeding, had received vapocoolant, or no intervention. |
| Blinding of outcome assessment (detection bias) | High risk | "NIPS was filled out during vaccination by a researcher in all three groups." (p. 4) The researcher completing the NIPS scores could not be blinded to whether the infant was breastfeeding. |
| Incomplete outcome data (attrition bias) | Unclear risk | Does not state how many participants were randomised. |
| Selective reporting (reporting bias) | Unclear risk | Study protocol not registered in trial registries searched. |
| Sample size | High risk | Fewer than 50 infants per arm. |
| Other bias | Low risk | Appears free of other bias. |
| Study characteristics | ||
| Methods | Randomised controlled trial at a single site (well‐child unit) in Turkey | |
| Participants | 158 infants ages 0 to 6 months, of which data for 70 infants aged 1 to 6 months were included in this review. Painful procedure: Multiple injections for vaccination (intramuscular or subcutaneous): Hepatitis B, bacillus Calmette‐Guérin, diphtheria‐tetanus‐pertussis and inactive polio, Haemophilus influenzae type b vaccination Study period: Not specified | |
| Interventions | Intervention: Breastfeeding before and during vaccination Control: No intervention | |
| Outcomes | Cry duration from time of needle insertion until all crying activity stopped NIPS score during vaccination | |
| Notes | Power calculation: No | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "A consecutive sample of 243 infants and children age 0 to 48 months receiving routine vaccinations were randomly assigned by the first assistant to 1 of the study groups, stratified by age using sealed envelopes." (p. 386) Specific randomisation method not described. |
| Allocation concealment (selection bias) | Unclear risk | "A consecutive sample of 243 infants and children age 0 Sealed envelopes used but does not specify whether envelopes were opaque and sequentially numbered. |
| Blinding of participants and personnel (performance bias) | High risk | "The mother was asked to continue breast‐feeding the infant during the procedure." (p. 386) Personnel could not be blinded to whether infant was breastfeeding or not. |
| Blinding of outcome assessment (detection bias) | High risk | "The paediatrician responsible for recording the crying time and pain score was not present during the interventions and was blinded to participant’s allocation except to the breast‐feeding group." (p. 386) The researcher completing the cry time and NIPS scores could not be blinded to whether the infant was breastfeeding or not. |
| Incomplete outcome data (attrition bias) | Low risk | "Four infants failed to complete the study because they did not resume feeding." (p. 386) Outcome data reported on all remaining infants. Less than 10% missing data. |
| Selective reporting (reporting bias) | Unclear risk | Study protocol not registered in trial registries searched. |
| Sample size | High risk | In the subgroup of infants aged 1 to 6 months included in this review, there were fewer than 50 infants per arm. |
| Other bias | Unclear risk | Children receiving subcutaneous and intramuscular injections as well as single and multiple injections included (p. 388). Unclear as to how these are broken down by intervention and control group in breastfeeding trial (only data on whole group provided). |
| Study characteristics | ||
| Methods | Randomised controlled trial at a single site (health child clinic) in Turkey | |
| Participants | 66 infants ages 2 to 4 months Painful procedure: DPT vaccination Study period: June 2001 to July 2002 | |
| Interventions | Intervention: Breastfeeding before, during, and after vaccination Control: Baby swaddled with only leg to be injected exposed, and positioned on soft mattress on examination table. Mothers encouraged to soothe infant vocally during and after the injection. The infant was cuddled by mother after vaccination. | |
| Outcomes | Cry duration from time of needle insertion until all crying activity stopped, up to 3 minutes Heart rate during the injection and after needle was removed Oxygen saturation during the injection and after needle was removed | |
| Notes | Power calculation: No | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Sixty‐six envelopes designating group assignments, 33 for breast‐feeding and 33 for control, were mixed and shuffled. After we obtained informed consent from the participants, we opened the top envelope from the stack to identify each infant’s group assignment." (p. 11) Infants were randomised by shuffling envelopes. |
| Allocation concealment (selection bias) | Unclear risk | "Sixty‐six envelopes designating group assignments, 33 for breast‐feeding and 33 for control, were mixed and shuffled." (p. 11) Envelopes were used but does not specify if they were opaque. |
| Blinding of participants and personnel (performance bias) | High risk | "At the end of the third minute of breast‐feeding, while the infants were still sucking, the immunization injections were performed. The nurse practitioner gave her standard care, which included giving advice, preparing and administering the immunization solutions, and supervising the soothing techniques." (p. 12) Personnel could not be blinded to whether infant was breastfeeding or not. |
| Blinding of outcome assessment (detection bias) | Low risk | "All infants were audiotaped (Sony M‐529V microcassette recorder)." (p. 12) The researcher completing the duration of cry time was blinded to intervention group since only audio recordings were used. |
| Incomplete outcome data (attrition bias) | Low risk | Outcome data reported on all 66 randomised infants. |
| Selective reporting (reporting bias) | Unclear risk | Study protocol not registered in trial registries searched. |
| Sample size | High risk | Fewer than 50 infants per arm. |
| Other bias | Low risk | Appears free of other bias. |
| Study characteristics | ||
| Methods | Randomised controlled trial at a single site (healthcare centre) in Iran | |
| Participants | 96 infants ages 6 to 12 months Painful procedure: DPT and MMR vaccination Study period: April to July 2011 | |
| Interventions | Intervention 1: Breastfeeding before and during vaccination Intervention 2: Massage on infant's palm or sole 1 minute before injection Control: Maternal hugging only | |
| Outcomes | NIPS score during vaccination | |
| Notes | Power calculation: No | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "The type of vaccine to be investigated was randomly selected from 96 envelopes marked as A and B, which the researcher had already made by random number table (zero was ignored; numbers 1, 2, 3 were assigned to the massage group; 4, 5, 6, to the breastfeeding group; and 7, 8, 9 to the control group)." (p. 4) Sequence generated using a random number table. |
| Allocation concealment (selection bias) | Unclear risk | "The envelope was selected and opened based on the age of the qualified subjects who had referred for vaccination, and according to an already recorded method, necessary interventions were conducted." (pp. 4‐5) Envelopes were used but does not specify if they were sequentially numbered, sealed, and opaque. |
| Blinding of participants and personnel (performance bias) | High risk | "In the mother's breast feeding group, the mother started breast feeding the infant and vaccination was conducted during active and constant sucking. In the massage therapy group, the researcher massaged the first knuckle of the middle or ring finger of the infants’ palm or sole of the injection side for 60 sec and finally vaccinated the subject." (p. 4) Personnel could not be blinded to whether infant was breastfeeding, receiving massage, or no intervention. |
| Blinding of outcome assessment (detection bias) | High risk | "Next, neonatal infant pain scale (NIPS) checklist, which is a standard tool to measure pain with its validity and reliability having been confirmed, [1,21] was ticked in all groups by a researcher through observing the subjects during the procedure of vaccination." (p. 4) The researcher completing the NIPS scores could not be blinded to whether the infant was breastfeeding or not. |
| Incomplete outcome data (attrition bias) | Low risk | "A total of 99 infants entered the study. Three infants were left out due to restlessness and cry before injection. Data analysis was conducted for 96 subjects." (p. 5) Outcome data reported on all remaining infants. Less than 10% missing data. |
| Selective reporting (reporting bias) | Unclear risk | Study protocol not registered in trial registries searched. |
| Sample size | High risk | Fewer than 50 infants per arm. |
| Other bias | Low risk | Appears free of other bias. |
| Study characteristics | ||
| Methods | Randomised controlled trial at a single site (immunisation clinic) in India | |
| Participants | 120 infants ages 6 weeks to 3 months Painful procedure: wDPT vaccination Study period: Not specified | |
| Interventions | Intervention 1: Breastfeeding before and during vaccination Intervention 2: 2 mL of 25% dextrose given orally 2 minutes prior to vaccination Control: 2 mL of distilled water given orally 2 minutes prior to vaccination | |
| Outcomes | Cry duration from time of needle insertion until a period of silence of more than 5 seconds, up to a maximum of 3 minutes (presented as median and IQR but converted to mean and standard deviation for meta‐analysis) Latency of onset of cry (the time from needle insertion to onset of vocalisation of cry) MFCS at time of needle insertion, 1 minute after needle insertion, and 3 minutes after needle insertion (presented in graphical form only) | |
| Notes | Power calculation: Yes (p. 650) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "The subjects were randomised into three groups of 40 each through computers generated random numbers and put in serially numbered opaque sealed envelopes (SNOSE method)." (p. 649) Sequence generated using computer‐generated random numbers. |
| Allocation concealment (selection bias) | Low risk | "The subjects were randomised into three groups of 40 each through computers generated random numbers and put in serially numbered opaque sealed envelopes (SNOSE method)." (p. 649) Serially numbered, opaque, sealed envelopes used. |
| Blinding of participants and personnel (performance bias) | High risk | "Babies in breastfed group were breastfed throughout the intervention, starting 2 minutes prior to the vaccination; 25% dextrose group: 2 ml of 25% dextrose was given orally by a sterile syringe 2 minutes prior to intramuscular vaccination; Placebo group: 2 ml distilled water was given orally by a sterile syringe 2 minutes prior to intramuscular vaccination." (p. 65) Personnel could not be blinded to whether or not infant was breastfeeding. |
| Blinding of outcome assessment (detection bias) | High risk | "All events were recorded by the investigator on a digital video camera (model Sony CCDTRV238E) for total duration of three minutes from the removal of the needle." (p. 650) The researcher completing the cry duration and MFCS could not be blinded to whether the infant was breastfeeding or not. |
| Incomplete outcome data (attrition bias) | Low risk | "120 babies were randomised into 3 groups of 40 babies each." (p. 650) Outcome data reported for all 120 randomised infants. |
| Selective reporting (reporting bias) | Unclear risk | Study protocol not registered in trial registries searched. |
| Sample size | High risk | Fewer than 50 infants per arm. |
| Other bias | Low risk | Appears free of other bias. |
| Study characteristics | ||
| Methods | Randomised controlled trial at a single site (immunisation clinic) in India | |
| Participants | 120 infants under the age of 3 months Painful procedure: wDPT vaccination Study period: October 2009 to September 2010 | |
| Interventions | Intervention 1: Breastfeeding before and during vaccination + 1 g topical EMLA Cream applied to injection site 60 minutes before vaccination Intervention 2: 2 mL of distilled water given orally 2 minutes prior to vaccination + 1 g topical EMLA Cream applied to injection site 60 minutes before vaccination Control: 2 mL of distilled water given orally 2 minutes prior to vaccination + 1 g topical placebo cream applied to injection site 60 minutes before vaccination | |
| Outcomes | Cry duration from time of needle insertion until a period of silence of more than 5 seconds, up to a maximum of 3 minutes Latency of onset of cry (the time from needle insertion to onset of vocalisation of cry) MFCS at time of needle insertion, 1 minute after needle insertion, and 3 minutes after needle insertion | |
| Notes | Power calculation: Yes (p. 1529) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "The subjects were randomised into three groups of 30 infants each through computer‐generated random numbers." (p. 1528) Sequence generated using computer‐generated random numbers. |
| Allocation concealment (selection bias) | Low risk | "The numbers were written on paper slips, and these slips were put in serially numbered opaque sealed envelopes (SNOSE method)." (p. 1528) Serially numbered, opaque, sealed envelopes used. |
| Blinding of participants and personnel (performance bias) | High risk | "Breastfeeding started 2 min prior to vaccination and continued throughout the procedure." (p. 1528) Personnel could not be blinded to whether or not infant was breastfeeding. |
| Blinding of outcome assessment (detection bias) | High risk | "All events were recorded by JK on a digital video camera (model Sony CCD‐TRV238E) for a total duration of 3 min from just before needle insertion." (p. 1528) The researcher completing the cry duration and MFCS could not be blinded to whether the infant was breastfeeding or not. |
| Incomplete outcome data (attrition bias) | Low risk | "A total of 90 babies were randomised in three groups of 30 each." (p. 1529) Outcome data reported for all 90 randomised infants. |
| Selective reporting (reporting bias) | Unclear risk | Study protocol available (CTRI ‐ CTRI/2011/06/001783), but trial registered retrospectively. |
| Sample size | High risk | Fewer than 50 infants per arm. |
| Other bias | Low risk | Appears free of other bias. |
| Study characteristics | ||
| Methods | Quasi‐RCT study at 2 sites (maternal and child health centres) in Jordan | |
| Participants | 120 infants ages 1 to 12 months Painful procedure: Vaccination (type not specified) Study period: Not specified | |
| Interventions | Intervention: Breastfeeding before, during, and after vaccination Control: No intervention | |
| Outcomes | Cry duration from time of needle insertion until all crying activity stopped NIPS score during vaccination Heart rate before and after injection | |
| Notes | Power calculation: No | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | "All infants included in the study were divided into two equivalent groups (of 60 infants)." (p. 100) No random sequence generation. *Quasi‐RCT study |
| Allocation concealment (selection bias) | Unclear risk | "All infants included in the study were divided into two equivalent groups (of 60 infants)." (p. 100) Not enough information to assess how allocation was concealed. *Quasi‐RCT study |
| Blinding of participants and personnel (performance bias) | High risk | "The mothers cradled their infants during breast‐feeding to maintain full‐body skin‐to‐skin contact during immunization injections." (p. 101) Personnel could not be blinded to whether or not infant was breastfeeding. |
| Blinding of outcome assessment (detection bias) | High risk | "The mothers cradled their infants during breast‐feeding to maintain full‐body skin‐to‐skin contact during immunization injections." (p. 101) The researcher completing the cry duration and pain scores (NIPS, Wong‐Baker) could not be blinded to whether the infant was breastfeeding or not. |
| Incomplete outcome data (attrition bias) | Low risk | "The subjects of this study were 120 infants chosen according to the following inclusion criteria: full‐term, age between 1 and 12 months old, breast‐feed, no concurrent illness." (p. 100) Outcome data reported for all 120 infants. |
| Selective reporting (reporting bias) | High risk | In Table 7 NIPS data are not presented consistent with the tool ‐ data is presented with scores from 0 to 4, rather than 0 to 7, and includes language from Wong‐Baker FACES Pain Rating Scale. |
| Sample size | Unclear risk | Between 50 and 199 infants per arm. |
| Other bias | High risk | Study used the Wong‐Baker FACES Pain Rating Scale, which is meant to be used for self assessment only. |
| Study characteristics | ||
| Methods | Randomised controlled trial at 2 sites (health clinics) in Iran | |
| Participants | 76 infants ages 2 to 4 months Painful procedure: DPT vaccination Study period: February 2008 to April 2008 | |
| Interventions | Intervention: Breastfeeding before, during, and after vaccination Control: No intervention | |
| Outcomes | MBPS 5 seconds before injection and 15 seconds after injection | |
| Notes | Power calculation: Yes (p. 35) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random number table used. |
| Allocation concealment (selection bias) | Unclear risk | Not enough information provided to assess. |
| Blinding of participants and personnel (performance bias) | High risk | Personnel could not be blinded to whether or not infant was breastfeeding. |
| Blinding of outcome assessment (detection bias) | High risk | The researcher completing the MBPS scores could not be blinded to whether the infant was breastfeeding or not. |
| Incomplete outcome data (attrition bias) | Low risk | No missing outcome data. |
| Selective reporting (reporting bias) | Unclear risk | Study protocol not registered in trial registries searched. |
| Sample size | High risk | Fewer than 50 infants per arm. |
| Other bias | Low risk | Appears free of other bias. |
| Study characteristics | ||
| Methods | Quasi‐RCT | |
| Participants | Infants aged 5 to 15 weeks and receiving their 1st, 2nd, or 3rd doses of DPT immunisation | |
| Interventions | Intervention: Breastfeeding 2 minutes before and during injection Control: No intervention. Position of infant not specified | |
| Outcomes | Modified NIPS at 1 and 5 minutes following injection. No description given of modifications made to the NIPS. | |
| Notes | Power calculation: No | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Authors did not specify how infants were allocated to each group. They stated "... 20 were assigned to the experimental group and 20 to the control group" (p. 184). They also stated: "Non‐probability purposive sampling technique was found more appropriate to make the study more feasible". It is unclear what this means. |
| Allocation concealment (selection bias) | Unclear risk | The following statement by the authors provided insufficient information to assess this category: "... Who possess their immunisation card were selected, out of which 20 were assigned to the experimental group and 20 to the control group" |
| Blinding of participants and personnel (performance bias) | High risk | Blinding of breastfeeding not possible |
| Blinding of outcome assessment (detection bias) | High risk | Outcome assessment done at the time of vaccine, therefore blinding of breastfeeding not possible. |
| Incomplete outcome data (attrition bias) | Low risk | 40 infants were included, and data were reported for 40 infants. |
| Selective reporting (reporting bias) | Unclear risk | Study protocol not registered in trial registries searched. |
| Sample size | High risk | Fewer than 50 infants per arm. |
| Other bias | Low risk | Appears free of other bias. |
DPT: diphtheria‐pertussis‐tetanus
IQR: interquartile range
MBPS: Modified Behavioral Pain Scale
MFCS: Modified Facial Coding System
MMR: measles, mumps, rubella
NFCS: Neonatal Facial Coding System
NIPS: Neonatal Infant Pain Scale
RCT: randomised controlled trial
wDPT: whole cell diphtheria‐pertussis‐tetanus
Characteristics of excluded studies [ordered by study ID]
| Study | Reason for exclusion |
| Breastfeeding was not used during the painful procedure. | |
| Conference abstract | |
| Conference abstract | |
| Infants younger than inclusion criteria. | |
| Infants younger than inclusion criteria. | |
| Breastfeeding was not used during the painful procedure. | |
| Infants younger than inclusion criteria. | |
| Not a randomised controlled trial (review) | |
| Breastfeeding was not used during the painful procedure. | |
| Infants younger than inclusion criteria. | |
| Conference abstract | |
| Conference abstract; appeared to be same population as Taavoni 2010, Taavoni 2011, and Taavoni 2012; presented information found in published study included in this review (Taavoni 2009a). | |
| Conference abstract; appeared to be same population as excluded studies Taavoni 2009b, Taavoni 2011, and Taavoni 2012; presented information found in published study included in this review (Taavoni 2009a). | |
| Conference abstract; appeared to be same population as excluded studies Taavoni 2009b, Taavoni 2010, and Taavoni 2012; presented information found in published study included in this review (Taavoni 2009a). | |
| Conference abstract; appeared to be same population as excluded studies Taavoni 2009b, Taavoni 2010, and Taavoni 2011; presented information found in published study included in this review (Taavoni 2009a). | |
| Conference abstract | |
| Infants younger than inclusion criteria. |
Characteristics of ongoing studies [ordered by study ID]
| Study name | Comparison of breastfeeding and 25% oral dextrose for pain relief during immunization of infants: a randomized controlled trial |
| Methods | Randomised controlled trial at a single site (immunisation clinic) in India |
| Participants | Infants ages 1 to 6 months Painful procedure: Pentavalent vaccination |
| Interventions | Intervention 1: Breastfeeding before and during vaccination Intervention 2: 2 mL of 25% dextrose given orally 2 minutes prior to vaccination |
| Outcomes | FLACC score at time of needle insertion, 1 minute after needle insertion, and 3 minutes after needle insertion |
| Starting date | 15 May 2014 (first infant enrolled) |
| Contact information | Dr. Anna Mathew MOSC Medical College, Department of Pharmacology Ernakulam, Kerala, PIN 682311, India 9442221950 |
| Notes | Study registered on Clinical Trials Registry ‐ India (CTRI #CTRI/2014/07/004724) |
FLACC: Face, Legs, Activity, Cry, Consolability
Data and analyses
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 Cry duration Show forest plot | 6 | 547 | Mean Difference (IV, Random, 95% CI) | ‐38.09 [‐49.84, ‐26.35] |
| Analysis 1.1  Comparison 1: Breastfeeding versus control, Outcome 1: Cry duration | ||||
| 1.2 All pain scores during injection Show forest plot | 5 | 310 | Std. Mean Difference (IV, Random, 95% CI) | ‐1.73 [‐2.20, ‐1.25] |
| Analysis 1.2  Comparison 1: Breastfeeding versus control, Outcome 2: All pain scores during injection | ||||
| 1.3 NIPS Show forest plot | 3 | 174 | Mean Difference (IV, Random, 95% CI) | ‐1.89 [‐2.55, ‐1.24] |
| Analysis 1.3  Comparison 1: Breastfeeding versus control, Outcome 3: NIPS | ||||
| 1.4 Heart rate after injection Show forest plot | 2 | 186 | Mean Difference (IV, Random, 95% CI) | ‐3.56 [‐23.17, 16.05] |
| Analysis 1.4  Comparison 1: Breastfeeding versus control, Outcome 4: Heart rate after injection | ||||
Study flow diagram.
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Forest plot of comparison: 1 Breastfeeding versus control, outcome: 1.1 Cry duration.
Forest plot of comparison: 1 Breastfeeding versus control, outcome: 1.2 All pain scores during injection.
Forest plot of comparison: 1 Breastfeeding versus control, outcome: 1.3 NIPS.
Comparison 1: Breastfeeding versus control, Outcome 1: Cry duration
Comparison 1: Breastfeeding versus control, Outcome 2: All pain scores during injection
Comparison 1: Breastfeeding versus control, Outcome 3: NIPS
Comparison 1: Breastfeeding versus control, Outcome 4: Heart rate after injection
| Breastfeeding compared with other interventions, oral water, or no treatment for pain during vaccination in infants 1 to 12 months | ||||
| Patient or population: Infants 1 to 12 months during vaccination Settings: Diverse community settings Intervention: Breastfeeding Comparison: Other interventions, such as cuddling, sweet solutions, or placebo (oral water) or no treatment | ||||
| Outcomes | No of Participants | Effect Estimates and 95% CI | Quality of the evidence | Comments |
|---|---|---|---|---|
| Cry duration Seconds cry time during procedure or proportion of crying during procedure. Crying was measured during and up to 3 minutes following completion of vaccination. | 547 (6 studies) | MD (seconds) ‐38 ( ‐49.84 to 26.35) | Moderate | Not further downgraded: Breastfeeding consistently resulted in a reduction of crying time. However, as most trials included infants aged 1 to 6 months, further research including older infants up to 12 months of age may have an important impact on our confidence in the estimate of effect and may change the estimate. |
| All pain scores during injection Due to range of pain scores used, data analysed using SMDs. Pain scores were measured during and up to 3 minutes following completion of vaccination. | 310 (5 studies) | SMD ‐1.7 ( ‐2.2 to ‐1.3) | Moderate | Downgraded once: Breastfeeding consistently resulted in a reduction of pain scores. However, only 5 studies and 310 infants were included, and most of the trials included the younger infants aged 1 to 6 months. Further research including older infants up to 12 months of age and larger sample sizes may have an important impact on our confidence in the estimate of effect. |
| NIPS score during injection The NIPS was measured during and up to 3 minutes following completion of vaccination. | 174 (3 studies) | MD ‐1.89 (‐2.55 to ‐1.24) | Low | Not further downgraded: Grade of evidence already taken into account. Only 3 studies and 174 infants were included. Further studies using this pain assessment score may lead to more certainty and have an important impact on our confidence in the estimate of effect. |
| Heart rate after injection Heart rate in the period following completion of the injections was measured in 2 studies. | 186 (2 studies) | MD (beats per minute) ‐3.6 ( ‐23 to 16) | Low | Not further downgraded: Grade of evidence already taken into account. Breastfeeding did not have an effect on heart rate change from baseline. As only 2 studies were included in this outcome, 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. |
| Adverse events | No studies reported on adverse events. | ‐ | Very low | No studies reported on outcomes such as coughing or gagging. |
| CI: confidence interval; MD: mean difference; NIPS: Neonatal Infant Pain Scale; SMD: standardised mean difference | ||||
| GRADE Working Group grades of evidence | ||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 Cry duration Show forest plot | 6 | 547 | Mean Difference (IV, Random, 95% CI) | ‐38.09 [‐49.84, ‐26.35] |
| 1.2 All pain scores during injection Show forest plot | 5 | 310 | Std. Mean Difference (IV, Random, 95% CI) | ‐1.73 [‐2.20, ‐1.25] |
| 1.3 NIPS Show forest plot | 3 | 174 | Mean Difference (IV, Random, 95% CI) | ‐1.89 [‐2.55, ‐1.24] |
| 1.4 Heart rate after injection Show forest plot | 2 | 186 | Mean Difference (IV, Random, 95% CI) | ‐3.56 [‐23.17, 16.05] |
