A Randomised Controlled Trial of Pasteurised Donor Human Milk as Supplementary Nutrition for Infants Born to Women With Diabetes in Pregnancy

What this Trial Is About

This research investigates whether giving pasteurized donor human milk (PDHM) as extra nutrition in the first five days of life to full-term infants born to women with diabetes during pregnancy can lower the chance of these infants being admitted to a neonatal unit for low blood sugar management. The study also looks at other important outcomes like breastfeeding rates, mothers' mental health, and the occurrence of cow's milk allergy in infants. Diabetes in pregnancy is increasingly common and can lead to infants needing special care, often relying on cow's milk formula when maternal milk is not sufficient. The trial has two groups: one group receives PDHM as supplementary nutrition from the time of randomization until five days after birth, including frozen milk supply for home use if discharged early. The other group receives standard hospital care, which may include infant formula or other nutrition as recommended by clinicians. PDHM access ends after 120 hours of life, after which feeding continues as usual. After hospital discharge, families will complete electronic questionnaires at 2 and 6 weeks, and 6 and 12 months to assess feeding practices, maternal quality of life, and infant allergy symptoms. Participants will be closely monitored with various assessments including infant blood sugar levels, hospital admissions, breastfeeding status, maternal mental health surveys, infant growth, allergy testing, and antibiotic use during the first year. The main outcome measured is the proportion of infants admitted for hypoglycemia management within the first 120 hours. The study runs from birth through one year, with follow-ups to gather comprehensive data on health and wellbeing for both mother and child.

Pasteurised Donor Human Milk Supplementation for Term Babies