The Effect of Early Limited Formula on Breastfeeding, Readmission, and Intestinal Microbiota: A Randomized Clinical

Valerie J Flaherman1, Nicole R Narayan2, Dennis Hartigan-O'Connor2

  • 1Department of Pediatrics, University of California San Francisco, San Francisco, CA.

Insights

Early limited formula (ELF) supplementation in newborns with significant weight loss did not negatively impact breastfeeding duration or gut microbiota. This intervention may reduce infant readmission rates without compromising exclusive breastfeeding goals.

Area of Science:

  • Neonatal care
  • Pediatric nutrition
  • Microbiome research

Background:

  • Infant weight loss is a common concern, often leading to formula supplementation.
  • The impact of early, limited formula supplementation on breastfeeding outcomes and infant gut microbiota is not fully understood.

Purpose of the Study:

  • To evaluate the effect of early limited formula (ELF) supplementation on breastfeeding duration, infant readmission rates, and intestinal microbiota composition up to one month of age.
  • To determine if 10 mL of formula after each breastfeeding session, prior to mature milk production, influences these outcomes.

Main Methods:

  • A randomized controlled trial involving 164 exclusively breastfeeding newborns (24-72 hours old) with weight loss ≥75th percentile.
  • Infants were randomized to either ELF supplementation or exclusive breastfeeding (control).
  • Outcomes including breastfeeding duration, readmission, and intestinal microbiota were assessed through 1 month post-birth.

Main Results:

  • No significant difference in breastfeeding rates at 1 week (95.8% ELF vs. 93.5% control) or 1 month (86.5% ELF vs. 89.7% control) was observed.
  • Readmission rates were lower in the ELF group (0%) compared to the control group (4.8%), though not statistically significant (P=0.06).
  • ELF supplementation did not negatively affect the abundance of beneficial bacteria (Lactobacillus, Bifidobacterium) or promote harmful bacteria (Clostridium) in the infant gut.

Conclusions:

  • Early limited formula supplementation in high-risk newborns does not interfere with breastfeeding at 1 month or alter intestinal microbiota.
  • ELF may serve as a valuable therapeutic strategy to potentially decrease infant readmission rates.
  • This approach supports continued breastfeeding without compromising the infant's gut microbiome development.
Abstract

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