Donor human milk for maternal milk shortfall in preterm infants: a feasibility randomised controlled trial

Objective To explore the feasibility of a randomised controlled trial (RCT) of donor human milk (DHM) use for preterm infants with mother’s own milk (MOM) shortfall, assessing DHM impact on breastfeeding. Design Feasibility, open-label RCT. Setting Two tertiary neonatal intensive care units in the UK. Patients 135 infants born before 33 weeks’ gestation or with birth weight <1500 g whose mothers intended to provide MOM admitted between June 2021 and March 2023. Interventions Infants were randomly assigned to either DHM for MOM shortfall until full feeds (FFs) and preterm formula thereafter, control (DHM-FF group) or the intervention, DHM until 36 weeks corrected gestational age (CGA) or discharge if sooner (DHM-36w group). Main outcome measures Feasibility outcomes included study recruitment, retention and intervention feasibility measures. The primary clinical outcome was breastfeeding or receipt of any MOM at 36 weeks CGA or discharge if sooner. Secondary clinical outcomes included growth and neonatal morbidities. Results Of 325 screened infants, 247 were eligible, out of which 135 were recruited (54.7%). Parents of 36 infants declined DHM. Three infants discontinued DHM use during the study. 13 infants could not access the intervention due to transfer. 38/66 (57.6%) infants from the DHM-FF group and 40/69 (58%) infants from the DHM-36w group received some MOM at 36 weeks’ CGA. There were no significant differences between groups in growth and morbidity outcomes. Conclusions The RCT design is feasible for future, larger-scale studies. Availability of MOM did not differ between groups at 36 weeks but was higher than historical cohorts. Trial registration number 57339063.