Immediate fortification of human milk with a bovine milk-derived human milk fortifier in very low birth weight infants: a randomized clinical trial

Objective: Double-blind randomized control trial of early addition of a bovine milk-derived human milk fortifier (HMF) in very low birth weight (VLBW) infants (NCT05228535). Methods: VLBW infants were randomized to receive bovine milk-derived HMF with first feedings or delayed fortification at 80 ml/kg/day. Anthropometrics were assessed weekly through 36 weeks postmenstrual age (PMA). Unadjusted and adjusted (race, gender, gestational age, and birth weight) differences between study arms were examined using two-sample t-test and ANCOVA, respectively. Results: Fifty-two VLBW infants (57% female, 60% Black) were enrolled. Baseline demographics did not differ between groups. Weight velocity at DOL 28 did not differ between study arms. Secondary outcomes including NPO occurrence, incidence of metabolic acidosis, NEC, retinopathy, or late-onset sepsis did not differ between groups. Conclusion: Immediate fortification of enteral feedings with a bovine milk-derived HMF appears safe and well-tolerated although no clear growth benefit could be established.