Giving limited formula supplementation before abundant maternal milk production is established may not adversely impact breastfeeding

EBM Focus - Volume 13, Issue 23

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Reference: J Pediatr 2018 May;196:84 (level 2 [mid-level] evidence)

  • Exclusive breastfeeding is recommended for the first six months of life, but low maternal milk volume during the initial postnatal period may lead to complications in some newborns. A recent randomized trial evaluated whether limited supplementation with formula before abundant milk production is established adversely effects breastfeeding.
  • In this trial, 164 exclusively breast-fed newborns (age range 24-72 hours) who had pronounced weight loss were randomized to 10 mL syringe-administered formula supplementation after each breastfeeding until abundant milk production was achieved vs. exclusive breastfeeding.
  • There was no significant difference in rates of breastfeeding at 1 month between neonates given limited formula supplementation vs. exclusive breastfeeding (86.5% vs. 89.7%). Limited formula supplementation was associated with a nonsignificant decrease in neonatal hospital readmissions (0% vs. 4.8%, p = 0.06).

Exclusive breastfeeding, except for vitamins, minerals, and medications, for the first six months of life is recommended by several health organizations (Pediatrics 2012, American Academy of Family Physicians 2015, Obstet Gynecol 2016). Before abundant maternal milk production is established, some exclusively breastfed newborns may have an increased risk of hyperbilirubinemia and dehydration (J Pediatr 2008, Asia Pac J Clin Nutr 2010). Supplementation during early life, however, is discouraged due to concerns that it may alter intestinal microbiota and negatively impact continued breastfeeding. In a recent trial, 164 healthy, singleton infants born ≥ 37 weeks gestation (age range 24-72 hours) who were exclusively breastfed and had pronounced weight loss (≥ 75th percentile for age) were randomized to limited formula supplementation vs. continuation with exclusive breastfeeding. Supplementation consisted of giving the newborn 10 mL formula via feeding syringe after each breastfeeding, and was stopped after abundant maternal milk production was established. Breastfeeding status was assessed via telephone interview conducted by an outcome assessor blinded to treatment allocation.

Newborns in the supplementation group received formula on an average of 5.4 times per day for a median of 2 days, and 37% of newborns in the control group had been given some formula by one week of age. There were no significant differences in the rates of breastfeeding at 1 month (86.5% with supplementation vs. 89.7% with exclusive breastfeeding, risk ratio for cessation 1.21, 95% CI 0.55-3.16) or rates of breastfeeding without formula use in the previous 24 hours (54.6% vs. 65.8%). None of the newborns in the supplementation group were readmitted to the hospital, while 5 newborns (4.8%) in the control group were (p = 0.06). The reasons for readmission in the control group were hyperbilirubinemia in 3, umbilical infection in 1, and unknown in 1.

The findings of this trial suggest that early limited formula supplementation of breastfeeding does not significantly reduce rates of continued breastfeeding at 1 month. The confidence in this finding is tempered by the wide 95% confidence interval in risk of breastfeeding cessation, which includes the possibilities of both beneficial and adverse clinically significant differences. It should be noted that supplementation was given via a feeding syringe rather than a bottle, and this may have helped to avoid nipple confusion, which may interfere with breastfeeding in some infants. A possible benefit of early supplementation in these neonates was suggested by the reduced rate of hospital readmissions, but this difference did not reach statistical significance. Preliminary analyses of intestinal microbiota conducted on 15 convenience stool samples taken during the trial were promising in that they suggest that the limited use of formula may not reduce the abundance of Lactobacillus or increase the abundance of Clostridia. These findings, however, require further investigation. Finally, the generalizability of the findings is limited by the low representation of women under 25 years of age (< 15%), a population at increased risk of early discontinuation (J Pediatr Gastroenterol Nutr 2015). In summary, this trial suggests that temporary and limited syringe-administered formula supplementation until an abundant maternal milk supply is established may be considered for selected neonates and their mothers.

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