Neonatal HypoglycemiaMetabolic ComplicationCows Milk AllergyHospital Length of StayNeonatal Intensive Care UnitBreastfeedingMental Health Issue
Investigational drug(s) / intervention(s)
Standard care Cow's milk based formulaDietary Supplement: PDHM Pasteurised Donor Human Milk
Standard care Cow's milk based formula: Standard hospital care would be given as as per local unit policy at the site.
Dietary Supplement: PDHM Pasteurised Donor Human Milk: PDHM will be given to infants randomised to the intervention group
Study summary
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.
Eligibility
Sex
ALL
Min age
0 Hours
Max age
48 Hours
Healthy volunteers
No
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
Primary outcome measure(s)
Proportion of infants admitted to neonatal unit for management of hypoglycaemia — From birth to 120 hours of life Proportion of infants in intervention and standard care groups admitted to a neonatal unit for management of hypoglycaemia.
Trial sites (4)
Facility
City
Region
Status
Royal Brisbane and Womens Hospital (QLD)
Brisbane
Queensland
Not Yet Recruiting
Greenslope Hospital (QLD)
Brisbane
Queensland
Not Yet Recruiting
Frances Perry House (VIC)
Melbourne
Victoria
Recruiting
Royal Womens Hospital (VIC)
Melbourne
Victoria
Recruiting
More The University of Queensland trials in Australia
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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