Pasteurised donor human milk for term babies born to mothers with diabetes
A Randomised Controlled Trial of Pasteurised Donor Human Milk as Supplementary Nutrition for Infants Born to Women With Diabetes in Pregnancy.
This trial will try giving pasteurised donor human milk instead of formula to term infants of mothers with diabetes during the first five days to see if it reduces neonatal unit admissions for low blood sugar.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 1444 (estimated) |
| Ages | 0 Hours to 48 Hours |
| Sex | All |
| Sponsor | The University of Queensland Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 4 sites (Brisbane, Queensland and 3 other locations) |
| Trial ID | NCT06993103 on ClinicalTrials.gov |
What this trial studies
PRESENT is a multi-center, randomized controlled trial comparing in-hospital pasteurised donor human milk (PDHM) supplementation versus local standard care (which may include cow's milk formula) for term infants born to women with type 1, type 2, or gestational diabetes. Eligible infants (≥37 weeks, >2.5 kg) whose clinician decides supplemental nutrition is needed within 48 hours of birth are randomized to receive PDHM until day 5 or to continue usual care per local policy. The primary outcome is the proportion of infants admitted to a neonatal unit for management of hypoglycaemia; secondary outcomes include breastfeeding rates, maternal mental health, and infant cow's milk allergy. Parents complete electronic questionnaires at 2 and 6 weeks and 6 and 12 months after birth to capture feeding and health outcomes.
Who should consider this trial
Good fit: Ideal candidates are mother–infant pairs where the mother is over 18 with diabetes in pregnancy, intends to breastfeed, and the term infant (≥37 weeks, >2.5 kg) requires supplementary nutrition within the first 48 hours after birth.
Not a fit: Pairs unlikely to benefit include those who do not need supplemental feeding, multiple pregnancies, mothers with contraindications to breastfeeding (e.g., HIV, chemotherapy), or infants with clinical conditions that exclude trial enrolment.
Why it matters
Potential benefit: If successful, providing PDHM could reduce neonatal unit admissions for hypoglycaemia, lower early exposure to cow's milk formula, and improve breastfeeding and maternal well-being.
How similar studies have performed: PDHM has documented benefits in very preterm or very low birthweight infants, but using PDHM for term infants to prevent hypoglycaemia and reduce neonatal unit admissions is relatively novel and less well studied.
Eligibility criteria
Show full inclusion / exclusion 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 consent. * Infant is born at ≥ 37 weeks and weighs \> 2.5kg * Clinician caring for infant decides that supplementary nutrition (in addition to maternal breast milk) is required within the first 48 hours after birth. * Parent/s provide/s a signed and dated informed consent form and has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf. Exclusion Criteria: Mother/infant pairs meeting any of the following criteria will be excluded from the trial: * Multiple pregnancy * Mother has a condition that precludes maternal breast milk consumption e.g. HIV, receiving chemotherapy * Infant has clinically significant congenital abnormality interfering with effective breastfeeding or breast milk consumption (e.g., cleft lip and palate, metabolic disorder) and/or requiring immediate care in a neonatal unit (e.g., congenital heart disease). * Infant has received infant formula prior to randomisation. * Infant admitted to neonatal intensive care prior to randomisation. * More than 48 hours old at the time of recruitment
Where this trial is running
Brisbane, Queensland and 3 other locations
- Royal Brisbane and Womens Hospital (QLD) — Brisbane, Queensland, Australia (Not_yet_recruiting)
- Greenslope Hospital (QLD) — Brisbane, Queensland, Australia (Not_yet_recruiting)
- Frances Perry House (VIC) — Melbourne, Victoria, Australia (Not_yet_recruiting)
- Royal Womens Hospital (VIC) — Melbourne, Victoria, Australia (Recruiting)
Study contacts
- Principal investigator: Jennifer Koplin, PhD — Child Health Research Centre, University Of Queensland
- Study coordinator: Jennifer Koplin, PhD
- Email: j.koplin@uq.edu.au
- Phone: 061+0400032577
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.