Growth and safety evaluation in very low birth weight infants receiving an exclusive human milk diet: a phase III randomized control trial in Japan

To determine safety and efficacy of exclusive human milk diet (EHMD) for very low birth weight (VLBW, <1500 g) infants. Prospective, controlled, open trial of VLBW infants randomized to EHMD (mother’s own milk [MOM]/donor milk [DM] with human milk-based fortifiers) or Standard Diet (MOM/DM with cow milk-based fortifier/formula). Outcomes included superiority of weight gain velocity from birth to 34 weeks gestational age, time to full feeds, and safety. In total, 147 infants received EHMD (n = 77) or Standard Diet (n = 70). The EHMD group had superior mean weight gain velocity versus the Standard Diet (13.44 vs 11.96 g/kg/day, p = 0.006) and earlier mean time to full feeds (20.0 vs 25.9 days, p = 0.03); adverse events were not significantly different (32.5% vs 21.4%, p = 0.13). EHMD is viable for management of VLBW infants, providing improved growth without reduced safety. Japan Registry of Clinical Trials: jRCT2031210384