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

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.