Pasteurised Donor Human Milk Supplementation for Term Babies

Launched by THE UNIVERSITY OF QUEENSLAND · May 19, 2025

Keywords

ClinConnect Summary

The PRESENT trial is studying whether giving pasteurized donor human milk to newborns in their first five days of life can help reduce the number of babies who need special care for low blood sugar (hypoglycemia). This study is specifically looking at term infants born to mothers who have diabetes during pregnancy. Researchers want to see if this milk can also improve breastfeeding rates, support mothers' mental health, and reduce the risk of cow's milk allergy in babies.

To be eligible for the trial, mothers must be over 18, have diabetes (type 1, type 2, or gestational), and plan to breastfeed for at least six weeks. The baby must be born after 37 weeks of pregnancy, weigh more than 2.5 kg, and need extra nutrition soon after birth. Participants will be randomly assigned to either receive the donor milk or standard care for their baby. After leaving the hospital, families will fill out questionnaires at various times to share their experiences with feeding and any health concerns. This trial is a way to explore better nutrition options for newborns and support for new mothers.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Each participant must meet all the following criteria to be enrolled in this trial:
• • Mother is \>18 years at the time of consent
• • Mother has diabetes in pregnancy (type 1, type 2 or gestational diabetes)
• • Mother intends to breastfeed for at least 6 weeks at the time of consent.
• • Infant is born at ≥ 37 weeks and weighs \> 2.5kg
• • Clinician caring for infant decides that supplementary nutrition (in addition to maternal breast milk) is required within the first 48 hours after birth.
• • Parent/s provide/s a signed and dated informed consent form and has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.
• Exclusion Criteria:
• Mother/infant pairs meeting any of the following criteria will be excluded from the trial:
• • Multiple pregnancy
• • Mother has a condition that precludes maternal breast milk consumption e.g. HIV, receiving chemotherapy
• • Infant has clinically significant congenital abnormality interfering with effective breastfeeding or breast milk consumption (e.g., cleft lip and palate, metabolic disorder) and/or requiring immediate care in a neonatal unit (e.g., congenital heart disease).
• • Infant has received infant formula prior to randomisation.
• • Infant admitted to neonatal intensive care prior to randomisation.
• • More than 48 hours old at the time of recruitment