Supplementation of mother's own milk with term versus preterm donor human milk: a randomized controlled trial

The purpose of this is to evaluate the effect of supplementation of enteral feed volume with preterm versus term donor human milk (DHM) on short-term physical growth in very low birth weight (VLBW) neonates. In this open-label, variable block-sized, superiority, randomized controlled trial with allocation concealment, VLBW neonates with insufficient volume of mother's own milk (MOM) were assigned to receive either preterm (n = 48) or term (n = 54) DHM till discharge. Preterm DHM was defined as the breast milk expressed within 28 days of delivery at ≤ 34 weeks of gestation. The primary outcome was days to regain birth weight. Maternal and neonatal demographic variables were comparable in the two study groups. Days to regain birth weight were significantly more in the preterm DHM group, 17.4 (7.7) vs 13.6 (7.2) days, mean difference (95% CI) being 3.74 (0.48-7.0) days, P = 0.02). The proportion of MOM use was 82% in preterm vs 91.1%, P = 0.03 in the term milk group. Duration of skin-to-skin contact was also significantly lower in the preterm vs term milk group, the median (IQR) was 4 (0, 6) vs 4 (2, 6) hours/day, P < 0.01. However, bronchopulmonary dysplasia was higher in the preterm milk group (13% vs. 4%, P = 0.17). The velocity of gain in weight was similar in the two groups from week 1-3 but higher in the term DHM supplementation group during the 4th week. Conclusion: Supplementing MOM with preterm DHM did not result in a faster regaining of birth weight. Trial registration: CTRI/2020/02/023569; Date: 17.02.2020.