RecruitingPhase 4NCT06993103

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.


Sponsor

The University of Queensland

Enrollment

1,444 participants

Start Date

Dec 4, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 0 HoursMax Age: 48 Hours

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Dietary Supplement: PDHM Pasteurised Donor Human Milk and Standard care Cow's milk based formula for people with breastfeeding, hospital length of stay, and other related conditions. The study is currently recruiting participants at 4 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERStandard care Cow's milk based formula

Standard hospital care would be given as as per local unit policy at the site.

DIETARY_SUPPLEMENTDietary Supplement: PDHM Pasteurised Donor Human Milk

PDHM will be given to infants randomised to the intervention group


Locations(4)

Royal Brisbane and Womens Hospital (QLD)

Brisbane, Queensland, Australia

Greenslope Hospital (QLD)

Brisbane, Queensland, Australia

Frances Perry House (VIC)

Melbourne, Victoria, Australia

Royal Womens Hospital (VIC)

Melbourne, Victoria, Australia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06993103


Related Trials