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Pasteurised Donor Human Milk Supplementation for Term Babies

Study acronym: PRESENT
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Site details revised at 2 of 4 sites
    • Study description shortened, about 1 word
    v3
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date changed from estimate of Jun 2, 2025 to Dec 4, 2025
    • Interventions: Dietary Supplement: PDHM Pasteurised Donor Human Milk (Dietary Supplement), Standard care Cow's milk based formula (Dietary Supplement) to Dietary Supplement: PDHM Pasteurised Donor Human Milk (Dietary Supplement), Standard care Cow's milk based formula (Other)
    • Site details revised at 4 of 4 sites
    • Collaborators: 10 to 9
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06993103
Lead Sponsor The University of Queensland
Collaborators: Murdoch Childrens Research Institute, La Trobe University, University of Melbourne, South Australian Health and Medical Research Institute, Australian Red Cross Lifeblood, Monash University, The Royal Women Hospital, Frances Perry House (Ramsay Health), Ramsay Hospital Research Foundation
Conditions
(from sponsor)		 Neonatal Hypoglycemia, Metabolic Complication, Cows Milk Allergy, Hospital Length of Stay, Neonatal Intensive Care Unit, Breastfeeding, Mental Health Issue
Related terms Breast Feeding, Milk Hypersensitivity
Enrollment 1,444 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov