Condition: Neonatal Hypoglycemia · Metabolic Complication · Cows Milk Allergy · Sponsor: The University of Queensland
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.
This description comes directly from the study's public registry record.
Jennifer Koplin, PhD · 061+0400032577 · j.koplin@uq.edu.au
Vanessa Clifford, PhD · 061+0437 527 044 · VClifford@redcrossblood.org.au
Always discuss trial participation with your own doctor first.
| 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 |
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Source record: clinicaltrials.gov/study/NCT06993103