Actively Recruiting
Pasteurised Donor Human Milk Supplementation for Term Babies
Led by The University of Queensland · Updated on 2026-02-02
1444
Participants Needed
4
Research Sites
156 weeks
Total Duration
On this page
Sponsors
T
The University of Queensland
Lead Sponsor
M
Murdoch Childrens Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pasteurised Donor Human Milk Supplementation for Term Babies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Mother is over 18 years old 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 or later and weighs more than 2.5 kg
- Clinician decides that supplementary nutrition is needed within 48 hours after birth
- Parent or legal representative provides signed informed consent
You will not qualify if you...
- Multiple pregnancy
- Mother has conditions preventing breast milk consumption (e.g., HIV, chemotherapy)
- Infant has a significant congenital abnormality affecting breastfeeding or requires immediate neonatal care
- Infant received infant formula before randomisation
- Infant admitted to neonatal intensive care before randomisation
- Infant is more than 48 hours old at recruitment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Royal Brisbane and Womens Hospital (QLD)
Brisbane, Queensland, Australia, 4010
Not Yet Recruiting
2
Greenslope Hospital (QLD)
Brisbane, Queensland, Australia, 4101
Not Yet Recruiting
3
Frances Perry House (VIC)
Melbourne, Victoria, Australia
Not Yet Recruiting
4
Royal Womens Hospital (VIC)
Melbourne, Victoria, Australia
Actively Recruiting
Research Team
J
Jennifer Koplin, PhD
CONTACT
V
Vanessa Clifford, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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