AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

Pasteurised Donor Human Milk Supplementation for Term Babies

RecruitingPhase 4Ages 0 Hours - 48 HoursAllThe University of Queensland
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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 ques

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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
๐Ÿ’Š

What it tests

  • Standard care Cow's milk based formula
  • Dietary Supplement: PDHM Pasteurised Donor Human Milk
๐Ÿ“

Where

4 sites
Royal Brisbane and Womens Hospital (QLD)
Brisbane, Australia
Greenslope Hospital (QLD)
Brisbane, Australia
Frances Perry House (VIC)
Melbourne, Australia
Royal Womens Hospital (VIC)
Melbourne, Australia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy