Clinical trial NCT06993103: Pasteurised Donor Human Milk Supplementation for Term Babies
Official title: A Randomised Controlled Trial of Pasteurised Donor Human Milk as Supplementary Nutrition for Infants Born to Women With Diabetes in Pregnancy.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Neonatal Hypoglycemia
Metabolic Complication
Cows Milk Allergy
Hospital Length of Stay
Neonatal Intensive Care Unit
Breastfeeding
Mental Health Issue
Keywords: Pasteurised donor human milk
Donor breastmilk
Lead sponsor: The University of Queensland
Sponsor class: OTHER
Collaborators: name: Murdoch Childrens Research Institute
name: La Trobe University
name: University of Melbourne
name: South Australian Health and Medical Research Institute
name: Australian Red Cross Lifeblood
name: Ramsay Hospital Research Foundation
name: Monash University
name: The Royal Women Hospital
name: Greenslopes Private Hospital
name: Frances Perry House
First posted: 2025-05-28
Enrollment: 1444
Sex: ALL
Minimum age (years): 0
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled intervention trial - control and intervention arm
Primary purpose: PREVENTION

Brief 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.

Detailed description: Diabetes in pregnancy is becoming increasingly common globally, with more than 40 000 infants born to women with gestational diabetes alone in Australia each year. These infants are at a high risk of hypoglycaemia and often require admission to the neonatal intensive care unit (NICU) and frequent blood tests for glucose monitoring. Many lack access to sufficient maternal milk partly due to delayed lactogenesis, leading to reliance on cow's milk formula, which may increase risks of cow's milk allergy, early breastfeeding cessation, and long-term metabolic complications.

Pasteurized Donor Human milk (PDHM) supplementation represents an alternative to infant formula when sufficient mother's own milk is not available. In Australia, donor milk is already in use for more vulnerable populations (those born very preterm or of a very low birth weight). However, PDHM is not currently available for term infants, despite strong clinician and community demand.

Expanding the availability of PDHM to term infants has the potential to improve health outcomes for a much larger proportion of the population, with potential benefits for mothers and infants including a reduction in admissions to neonatal intensive care units, a reduction in cow's milk allergy in infants, and improved maternal mental health and breastfeeding outcomes.

Our project will assess the provision of PDHM as in-hospital supplementation for term infants who would otherwise be given cow's milk formula. This trial will address a significant gap in neonatal care and provide evidence to determine whether broader PDHM use could improve both mothers' and infants' and long-term health outcomes.

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 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 outcomes:
measure: Proportion of infants admitted to neonatal unit for management of hypoglycaemia
timeFrame: From birth to 120 hours of life
Secondary outcomes:
measure: Duration of hypoglycaemia (<2.6 mmol/L)
timeFrame: From birth upto 120 hours of life
measure: Proportion of infants requiring IV access for dextrose
timeFrame: From birth to 30 days after hospital discharge
measure: Episodes of phlebotomy
timeFrame: From birth up to 120 hours of life
measure: Hospital length of stay (infant)
timeFrame: From birth up to initial hospital discharge, up to 90 days of life
measure: Hospital re-admission within 30 days
timeFrame: From birth to 30 days after discharge
measure: Neonatal unit admission and length of stay (infant)
timeFrame: From birth to initial hospital discharge, up to 90 days of life
measure: Breast milk feeding
timeFrame: Breast milk feeding at 120 hours of age (this means received any breast milk in previous 24 hours) and at 2 & 6 weeks and 6 months of age
measure: Use of Formula feeding
timeFrame: Infant formula feeding at 120 hours of age (received any infant formula in previous 24 hours), and at 2 & 6 weeks and 6 &12 months of age
measure: Maternal mental health in the post-partum period GAD-7
timeFrame: At 6 weeks and 6 months post delivery
measure: Maternal mental health in the post-partum period using PHQ-9 survey
timeFrame: At 6 weeks and 6 months post delivery
measure: Maternal & Infant Health-related quality of life using AQoL-4D
timeFrame: At 6 weeks and 6 months post delivery
measure: Maternal & Infant Health-related quality of life using TANDI
timeFrame: At 6 weeks and 6 months post delivery
measure: Infant growth up to 12 months
timeFrame: At 4, 8 and 12 months of age
measure: Maternal metabolic health
timeFrame: At pre-birth, 6 and 12 months post delivery
measure: Maternal metabolic health
timeFrame: At 6-8 weeks after delivery
measure: Infant cow's milk allergy using Questionnaires
timeFrame: At 6 and 12 months
measure: Infant cow's milk allergy using SPT
timeFrame: At 6 and 12 months
measure: Infant cow's milk allergy using OFC challenge
timeFrame: At 6 and 12 months
measure: Infant antibiotic use in the first 12-months of life
timeFrame: At 6 weeks, 6 and 12 months
measure: Proportion of infants hospitalised with an infection in the first year of life
timeFrame: At 6 weeks, 6 and 12 months of age
Other outcomes:
measure: Exploratory outcomes: To explore the experience of supplementing using Pasteurised donor milk supplementation
timeFrame: At 6 week to 3 months
Locations:
city: Brisbane
country: Australia
facility: Royal Brisbane and Womens Hospital (QLD)
state: Queensland
city: Brisbane
country: Australia
facility: Greenslope Hospital (QLD)
state: Queensland
city: Melbourne
country: Australia
facility: Frances Perry House (VIC)
state: Victoria
city: Melbourne
country: Australia
facility: Royal Womens Hospital (VIC)
state: Victoria
Study officials:
affiliation: Child Health Research Centre, University Of Queensland
name: Jennifer Koplin, PhD
role: PRINCIPAL_INVESTIGATOR
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