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.
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
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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