One study had between 50 and infants enrolled in each arm and was thus rated as at unclear risk of bias Razek It should be noted that although Barr unpublished , Goswami , Gupta , and Taavoni a were rated as at high risk of bias for sample size based on the Cochrane PaPaS guidance on sample size, these four studies reported performing sample size calculations. It should also be noted that Dilli included infants between the ages of 0 and 6 months in their breastfeeding study 77 in breastfeeding group, 85 in control group , but because we only included the data for infants between the aged of 1 and 6 months, the reduced number per group led us to rate the study as at high risk of bias for sample size.
We rated most studies as at low risk for other sources of bias Barr unpublished ; Boroumandfar ; Efe ; Esfahani ; Goswami ; Gupta ; Taavoni a ; Thomas This tool is not validated for the infant population and was therefore rated as at high risk of bias. We rated one study as at unclear risk of bias due to demographic data including information on number of injections and type of injection being presented for the whole group only, rather than by intervention and control group Dilli See: Summary of findings for the main comparison Breastfeeding compared with other interventions, oral water, or no treatment for pain during vaccination in infants 1 to 12 months.
Six studies comparing breastfeeding infants in total to control conditions reported cry duration during immunisation. Three studies reported the duration of crying up to a maximum of 3 minutes Efe ; Goswami ; Gupta , and two studies reported the period until all crying ceased Dilli ; Razek One study reported the percentage of time the infant cried during three time periods Barr unpublished : 60 seconds before the injection; from time of injection to 10 seconds after the injection; and from 11 seconds to 60 seconds after the injection.
We obtained the raw data from the study authors. Barr unpublished collected data from the same infants at two months and again at four months. Gupta also included three groups: topical EMLA combined with breastfeeding; topical EMLA combined with water; and topical placebo cream combined with water.
We pooled data for cry time in seconds from these six studies. Analysis 1. We judged the quality of the evidence according to the GRADE criteria, for breastfeeding during vaccinations, on the outcome of cry duration, to be moderate. We did not further downgrade the quality of evidence, but consider that further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate summary of findings Table for the main comparison. Pain scores were collected at more than one time point for Gupta , Taavoni a , and Thomas Forest plot of comparison: 1 Breastfeeding versus control, outcome: 1.
We contacted the authors requesting raw data but did not receive a response.
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We judged the quality of the evidence according to the GRADE criteria, for breastfeeding during vaccinations, on the outcome of combined pain scores, to be moderate. Dilli included infants between the ages of 0 and 6 months, however they provided us with raw data, and we excluded infants under the age of 1 month from the analysis. We requested data from the authors but did not receive a response; we have therefore reported the data in narrative form only.
Razek presented the frequency of infants with NIPS scores of 0, 1, 2, 3, 4, and "hurts worst". The inclusion of the "hurts worst" category is inconsistent with the NIPS tool, which is a score ranging from 0 to 7. We judged the quality of the evidence according to the GRADE criteria, for breastfeeding during vaccinations, on the outcome of the behavioural pain score NIPS, to be moderate. One study measured heart rate during immunisation Efe Based on 66 infants, there was no statistically significant difference in mean heart rate.
As we could pool results for only two studies, we judged the quality of the evidence according to the GRADE criteria, for breastfeeding during vaccinations, on the outcome of heart rate differences, to be low. One study measured oxygen saturation during and after immunisation Efe There was no statistically significant difference in mean oxygen saturation during or following completion of the injection.
As only one study measured oxygen saturation, we judged the quality of the evidence to be very low. One study of 76 infants reported MBPS scores 5 seconds before the injection and 15 seconds after the injection Taavoni a. There was no significant difference in MBPS scores for the breastfeeding group 5 seconds before the injection, however breastfeeding resulted in a statistically significant mean reduction of MBPS of 3. Four studies had more than two study arms Boroumandfar ; Esfahani ; Goswami ; Gupta Our summaries of the results for these additional arms are as follows.
MFCS data were presented in graphical form only and therefore could not be extracted. In addition, the combination of breastfeeding and EMLA resulted in significantly shorter crying duration compared to both EMLA and water, and placebo cream and water. Boroumandfar included three study arms: breastfeeding, water and vapocoolant. They classified NIPS pain scores of greater than 3 as "pain". Esfahani reported that the mean standard deviation of NIPS in the breastfeeding, massage combined with maternal hugging, and maternal hugging only control groups were 3.
None of the included studies reported adverse effects such as choking, gagging, spitting, coughing, aspiration, or cyanosis.
Only Dilli reported the number of infants coming off the breast during the procedure, stating that 4 of the infants 2. We were unable to conduct planned subgroup analyses based on age of the infants at the time of study as data were not reported separately for the different ages. Importantly, however, only two studies included infants up to 12 months of age.
Esfahani included infants at 6 and 12 months of age, and Razek included infants from 1 month to 12 months of age. All trials evaluated breastfeeding during early childhood vaccination, with nine of the 10 evaluating breastfeeding during a single injection. Breastfeeding was not associated with a statistically significant reduction in physiological responses of heart rate or oxygen saturation levels. Results showed a statistically significant reduction in cry duration of 38 seconds associated with breastfeeding compared to control.
Only two studies reported physiological responses of heart rate following the vaccination procedure Efe ; Razek Only Efe reported oxygen saturation changes, and showed no differences between study groups. No study reported any adverse outcomes. In addition, no study reported on acceptability of breastfeeding, from the perspectives of mothers or healthcare providers, and no studies reported on the logistics of facilitating breastfeeding in the clinical settings. Only one study reported on infants failing to continue breastfeeding after the vaccination Dilli , and this applied to only a small number of infants.
Eight of the 10 trials included infants aged 1 to 6 months, with only 2 studies including older infants up to 1 year of age Esfahani ; Razek We could not conduct any subgroup analyses by age, as the study outcomes were not reported in sufficient detail to be extracted for pooling, or data differed. For example, Razek reported means and standard deviations of cry duration, and Esfahani reported means and standard deviations of NIPS scores.
However, individual results of these two studies were consistent with the overall results, showing a statistically significant reduction in behavioural pain responses. If mothers are breastfeeding, then breastfeeding is free during vaccinations. Its use is therefore recommended during early childhood vaccinations. Breastfeeding mothers are encouraged to advocate for their infants and request to breastfeed before and during early childhood vaccinations.
All 10 studies in this systematic review reported that breastfeeding reduced behavioural responses to pain during vaccination injections in infants beyond the newborn period compared to no treatment or control conditions. We can conclude that the results of this review are applicable to large populations of infants requiring early childhood immunisation. Potential benefits of breastfeeding during painful procedures, in addition to pain reduction for the infant, include the possibility that this may further encourage mothers to continue to breastfeed, and empower the mother through her knowledge that she can effectively reduce her baby's distress during a painful procedure.
However, if the mother did not establish breastfeeding, or had ceased to breastfeed by the time of early childhood vaccinations, or breastfeeding during vaccinations is simply not possible, sucrose or glucose with or without a pacifier can be recommended for pain treatment Harrison a ; Harrison c. Based on the Cochrane PaPaS guidance on sample size, we scored nine of the 10 included studies as high risk of bias, as there were fewer than 50 participants per arm.
However, three of these nine studies that included fewer than 50 participants per arm reported their a priori power calculation to inform their sample size. Most studies scored low risk of bias for incomplete outcome data and other bias, while results were variable for random sequence generation and allocation concealment. We were unable to identify completed protocols for most studies, therefore we predominantly gave a risk of bias rating of unclear for selective reporting bias. For behavioural responses of crying time and standardised pain scores, the overall evidence based on GRADE was moderate.
As most studies 8 out of 10 included infants in the younger age spectrum, of 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. As we could only pool heart rate data for two studies, evidence for physiological outcomes based on GRADE was considered to be low quality, and 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.
There were no known potential biases in the review process. We performed extensive searches of the literature with no language restrictions, and attempted to contact authors for additional information where required. In terms of effects of breastfeeding on behavioural responses to pain, these review findings agree with the systematic review of breastfeeding for procedural pain in newborn infants Shah , and a recently published systematic review of interventions to reduce vaccine pain that included infants and children Shah In all three systematic reviews, breastfeeding resulted in a statistically significant reduction in behavioural parameters and composite pain scores.
However, in this current systematic review, there were no consistent effects on physiological parameters of heart rate and oxygen saturation levels. This finding disagrees with the Cochrane systematic review of breastfeeding for procedural pain in neonates Shah , in which breastfeeding reduced heart rate change from baseline compared to being held by the mother, sucking on a pacifier, sucrose, or simply positioned supine or prone.
Both Shah and this current review included one study that compared breastfeeding with small volumes of sweet solutions. Results of both reviews showed that breastfeeding was associated with reduced behavioural responses to pain compared to sweet solutions. The 1. Adverse outcomes were not reported in any of the trials included in this review, or in the systematic review of breastfeeding for procedural pain in neonates Shah This suggests that there are no adverse outcomes such as airway compromise including coughing, choking, gagging, or aspiration. However, the inclusion of adverse events as an outcome measure and clear reporting of the same in future studies of breastfeeding all populations of infants and young children during painful procedures is recommended.
In this review, we identified no studies comparing formula feeding or bottle feeding expressed breast milk with breastfeeding. Shah included one such study in their systematic review of breastfeeding for procedural pain in neonates Weissman , which showed that formula feeding was as effective as breastfeeding in reducing behavioural and physiological responses during heel lance.
Although previous studies have shown that breastfeeding is infrequently used for vaccination pain management Lisi ; Russell ; Taddio , the global recommendations made by WHO, alongside the additional evidence of pain management effectiveness provided in this systematic review, may lead to more consistent adoption of this strategy in diverse settings where vaccinations take place.
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Skip to Content Cookies. I accept. Browse Advanced search. Content Language Selection. Your language preference is set to German. Where translations are available, article sections will display in this language. Return to English. Collapse all Expand all. Background Randomised controlled trials RCTs show that breastfeeding newborn infants during painful procedures reduces pain.
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Data collection and analysis We used standard methodological procedures expected by Cochrane. Main results We included 10 studies with a total of infants. No included studies reported adverse events. Authors' conclusions We conclude, based on the 10 studies included in this review, that breastfeeding may help reduce pain during vaccination for infants beyond the neonatal period. Hauptergebnisse Das Stillen verringerte das Weinen bei jungen Babys, die geimpft wurden. The recommendations have been adopted by some countries such as Italy, Denmark and Switzerland, in some cases with slight adjustments.
Table S1. Pregnant women should pay particular attention to the quality of their diet.