Giving Donor milk instead of formula in moderate-late preterm infants: the pilot GIFT Trial

This is a randomised case-control trial looking at a sample size of 100 infants per group to detect a reduction in the mean time to full enteral feeds (days) between the treatment groups of 0.5 standard deviations, with a two-sided alpha of 0.05 and 5% loss to follow-up. Study Infants will be fed with maternal breast milk each day (if available) and then supplemented with pasteurised donor human milk in a volume as determined by the treating health care team, based on the target volume of 150ml/kg/day or as specified in local unit protocols. The primary outcome is time to full enteral feeds (days), assessed by review of infant medical records.