Pasteurized Donor Milk for Newborns of Diabetic Mothers

Pasteurised Donor Human Milk Supplementation for Term Babies

Recruiting Phase 4 Interventional Study
Neonatal Hypoglycemia Metabolic Complication Cows Milk Allergy Hospital Length of Stay Neonatal Intensive Care Unit Breastfeeding Mental Health Issue
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
0 Hours – 48 Hours
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Prevention
Participants needed
1,444 (estimated)
Sponsor
The University of Queensland · Other
Who this trial is looking for

This trial is looking for mothers with diabetes in pregnancy whose infants need extra nutrition in the first few days after birth. Participants will receive either pasteurized donor human milk or standard care for their baby during this time.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am over 18 years old.
  • I have diabetes in pregnancy.
  • I plan to breastfeed for at least 6 weeks.
  • My baby was born at 37 weeks or later and weighs more than 2.5 kg.
  • My baby's doctor thinks my baby needs extra nutrition within 48 hours after birth.
  • I can provide signed consent for my participation.

You may not be able to join if

  • I am pregnant with more than one baby.
  • I have a condition that prevents me from producing breast milk.
  • My baby has a significant birth defect that affects breastfeeding.
  • My baby has received infant formula before joining the trial.
  • My baby was admitted to the neonatal unit before joining the trial.
  • My baby is more than 48 hours old when I want to join.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 a…
Trial Locations
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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 conse…
Contacts

Jennifer Koplin, PhD

061+0400032577

j.koplin@uq.edu.au

CONTACT

Vanessa Clifford, PhD

061+0437 527 044

VClifford@redcrossblood.org.au

CONTACT