Pasteurized Donor Milk for Newborns of Diabetic Mothers
Pasteurised Donor Human Milk Supplementation for Term Babies
Recruiting
Phase 4Interventional Study
Neonatal HypoglycemiaMetabolic ComplicationCows Milk AllergyHospital Length of StayNeonatal Intensive Care UnitBreastfeedingMental 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.
Ready to participate?
Review the details below, then apply to join this clinical 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
Who this trial is looking for
This trial is looking for mothers with diabetes in pregnancy whose infants need extra nutrition in the first few days after birth. Participants will receive either pasteurized donor human milk or standard care for their baby during this time.
Are You a Good Fit for This Trial?
You may be able to join if
I am over 18 years old.
I have diabetes in pregnancy.
I plan to breastfeed for at least 6 weeks.
My baby was born at 37 weeks or later and weighs more than 2.5 kg.
My baby's doctor thinks my baby needs extra nutrition within 48 hours after birth.
I can provide signed consent for my participation.
You may not be able to join if
I am pregnant with more than one baby.
I have a condition that prevents me from producing breast milk.
My baby has a significant birth defect that affects breastfeeding.
My baby has received infant formula before joining the trial.
My baby was admitted to the neonatal unit before joining the trial.
My baby is more than 48 hours old when I want to join.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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 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…
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 ≥ 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
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