Pasteurised Donor Human Milk Supplementation for Term Babies

PRESENT is a multi-center randomised controlled trial that aims to assess whether access to pasteurized donor human milk as supplementary nutrition in the first five days of life for term infants born to women with diabetes in pregnancy reduces the proportion of infants who are admitted to a neonatal unit for management of hypoglycemia compared with current standard hospital care. The trial will also assess other important outcomes including breastfeeding rates, maternal mental health, and infant cow's milk allergy. There will be two treatment arms. In the intervention arm, PDHM will be made available to infants from randomisation until day 5 of life. Infants allocated to the control arm will receive care as per local unit policy, including supplemental nutrition as recommended by the treating clinician. After hospital discharge, participants will be asked to complete an electronic questionnaire at 2 \& 6 weeks and 6 \& 12 months after birth. Questionnaires will assess infant feeding practices, maternal quality of life \[including anxiety and depression symptoms and health-related quality of life\] along with infant cow's milk allergy symptoms.

NCT Number	NCT06993103
Lead Sponsor	The University of Queensland Collaborators: Murdoch Childrens Research Institute, La Trobe University, University of Melbourne, South Australian Health and Medical Research Institute, Australian Red Cross Lifeblood, Monash University, The Royal Women Hospital, Frances Perry House (Ramsay Health), Ramsay Hospital Research Foundation
Conditions	Neonatal Hypoglycemia, Metabolic Complication, Cows Milk Allergy, Hospital Length of Stay, Neonatal Intensive Care Unit, Breastfeeding, Mental Health Issue
Enrollment	1,444 participants
Start Date	2025-12-04
Primary Completion	2028-04 (estimated)
Study Completion	2028-12 (estimated)
Updated on ClinicalTrials.gov	2026-02-02