Status:
NOT_YET_RECRUITING
Pasteurised Donor Human Milk Supplementation for Term Babies
Lead Sponsor:
The University of Queensland
Collaborating Sponsors:
Murdoch Childrens Research Institute
La Trobe University
Conditions:
Neonatal Hypoglycemia
Metabolic Complication
Eligibility:
All Genders
Up to 48 years
Phase:
PHASE4
Brief 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...
Detailed Description
Diabetes in pregnancy is becoming increasingly common globally, with more than 40 000 infants born to women with gestational diabetes alone in Australia each year. These infants are at a high risk of ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
1444 Patients enrolled
Trial Details
Trial ID
NCT06993103
Start Date
June 2 2025
End Date
December 1 2028
Last Update
May 28 2025
Active Locations (4)
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1
Royal Brisbane and Womens Hospital (QLD)
Brisbane, Queensland, Australia, 4010
2
Greenslope Hospital (QLD)
Brisbane, Queensland, Australia, 4101
3
Frances Perry House (VIC)
Melbourne, Victoria, Australia
4
Royal Womens Hospital (VIC)
Melbourne, Victoria, Australia