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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.
Objective:
To determine whether using 10 mL formula after each breastfeeding before copious maternal milk production affects breastfeeding duration, readmission, and intestinal microbiota through 1 month of age.
Study Design:
In this randomized controlled trial, we enrolled 164 exclusively breastfeeding newborns, 24-72 hours old, whose weight loss was ≥75th percentile for age, and whose mothers had not yet begun mature milk production. Enrolled newborns were assigned randomly to either supplement breastfeeding with early limited formula (ELF), 10 mL of formula after each breastfeeding stopped at the onset of copious maternal milk production (intervention), or to continue exclusive breastfeeding (control). Outcomes assessed through 1 month included breastfeeding duration, readmission, and intestinal microbiota.
Results:
At 1 week of age, 95.8% of infants receiving ELF and 93.5% of control infants were still breastfeeding (P > .5); readmission occurred for 4 (4.8%) control infants and none of the infants receiving ELF (P = .06). At 1 month of age, 86.5% of infants receiving ELF and 89.7% of control infants were still breastfeeding (P > .5); 54.6% of infants receiving ELF and 65.8% of controls were breastfeeding without formula (P = .18). ELF did not lead to decreased abundance of Lactobacillus or Bifidobacterium and was not associated with expansion of Clostridium.
Conclusion:
In this population of healthy newborns with weight loss ≥75th percentile, ELF did not interfere with breastfeeding at 1 month, breastfeeding without formula at 1 month, or intestinal microbiota. ELF may be an important therapeutic option for newborns with the potential to reduce readmission rates.
Trial Registration:
Clinicaltrials.gov: NCT02313181.
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