Actively Recruiting

Phase 4
Age: 0Hours - 48Hours
All Genders
NCT06993103

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

Age: 0Hours - 48Hours
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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