Trials / Recruiting

RecruitingNCT06993103

Pasteurised Donor Human Milk Supplementation for Term Babies

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

Status: Recruiting
Phase: Phase 4
Study type: Interventional
Enrollment: 1,444 (estimated)

Sponsor: The University of Queensland · Academic / Other
Sex: All
Age: 0 Hours – 48 Hours
Healthy volunteers: Not accepted

Summary

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.

Detailed description

Diabetes in pregnancy is becoming increasingly common globally, with more than 40 000 infants born to women with gestational diabetes alone in Australia each year. These infants are at a high risk of hypoglycaemia and often require admission to the neonatal intensive care unit (NICU) and frequent blood tests for glucose monitoring. Many lack access to sufficient maternal milk partly due to delayed lactogenesis, leading to reliance on cow's milk formula, which may increase risks of cow's milk allergy, early breastfeeding cessation, and long-term metabolic complications. Pasteurized Donor Human milk (PDHM) supplementation represents an alternative to infant formula when sufficient mother's own milk is not available. In Australia, donor milk is already in use for more vulnerable populations (those born very preterm or of a very low birth weight). However, PDHM is not currently available for term infants, despite strong clinician and community demand. Expanding the availability of PDHM to term infants has the potential to improve health outcomes for a much larger proportion of the population, with potential benefits for mothers and infants including a reduction in admissions to neonatal intensive care units, a reduction in cow's milk allergy in infants, and improved maternal mental health and breastfeeding outcomes. Our project will assess the provision of PDHM as in-hospital supplementation for term infants who would otherwise be given cow's milk formula. This trial will address a significant gap in neonatal care and provide evidence to determine whether broader PDHM use could improve both mothers' and infants' and long-term health outcomes.

Conditions

Interventions

Type	Name	Description
OTHER	Standard care Cow's milk based formula	Standard hospital care would be given as as per local unit policy at the site.
DIETARY_SUPPLEMENT	Dietary Supplement: PDHM Pasteurised Donor Human Milk	PDHM will be given to infants randomised to the intervention group

Timeline

Start date: 2025-12-04
Primary completion: 2028-04-01
Completion: 2028-12-01
First posted: 2025-05-28
Last updated: 2026-02-02

Locations

4 sites across 1 country: Australia

Source: ClinicalTrials.gov record NCT06993103. Inclusion in this directory is not an endorsement.