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NCT Number: NCT06993103

Pasteurised Donor Human Milk Supplementation for Term Babies

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.

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Key information

Conditions

Neonatal Hypoglycemia Behavior Breast Feeding Breastfeeding Cows Milk Allergy Feeding Behavior Food Hypersensitivity Hospital Length of Stay Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Mental Health Issue Metabolic Complication Milk Hypersensitivity Neonatal Intensive Care Unit

Age range

0 hour–48 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Greenslope Hospital (QLD), Brisbane, Queensland, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard care Cow's milk based formula

Other

Standard hospital care would be given as as per local unit policy at the site.

Other names: Standard Care_Formula milk

Dietary Supplement: PDHM Pasteurised Donor Human Milk

Dietary Supplement

PDHM will be given to infants randomised to the intervention group

Other names: PDHM_Donor milk

Primary outcomes

  1. Proportion of infants admitted to neonatal unit for management of hypoglycaemia

    Time frame: 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.

Secondary outcomes

  1. Duration of hypoglycaemia (<2.6 mmol/L)

    Time frame: From birth upto 120 hours of life

    Length of time until 3 consecutive total blood glucose >2.6 mmol/L (hours) from randomization

  2. Proportion of infants requiring IV access for dextrose

    Time frame: From birth to 30 days after hospital discharge

    By assessing the proportion of infants cannulated for IV dextrose during hospital admission or re-admission within 30 days of discharge.

  3. Episodes of phlebotomy

    Time frame: From birth up to 120 hours of life

    By assessing the number of episodes of phlebotomy during initial hospital admission to discharge (infant).

  4. Hospital length of stay (infant)

    Time frame: From birth up to initial hospital discharge, up to 90 days of life

    Duration of hospital stay from birth to hospital discharge, measured in hours.

  5. Hospital re-admission within 30 days

    Time frame: From birth to 30 days after discharge

    By assessing the proportion of infants with hospital re-admission within 30 days of discharge

  6. Neonatal unit admission and length of stay (infant)

    Time frame: From birth to initial hospital discharge, up to 90 days of life

    By assessing the proportion of infants admitted to the neonatal unit. For those admitted: the duration of admission (hours) will also be recorded.

  7. Breast milk feeding

    Time frame: 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

    An electronic questionnaire/survey will ask about any breast milk and/or exclusive breast milk feeding on separate occasions, including -

    • Day of onset of secretory activation
    • Infant receiving breastmilk (any, exclusive) in the previous 24 hours
    • at 2 weeks
    • at 6 weeks
    • at 6 months of age
    • Total duration of any breast milk feeding

    When relevant, would ask the reasons for stopping breastfeeding

  8. Use of Formula feeding

    Time frame: 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

    Any formula use; exclusive use of formula:

    • in 24 hours prior to discharge
    • at 2 weeks
    • at 6 weeks
    • at 6 months of age The timing of the first formula use (to estimate the duration of end of exclusive human milk-only feeding) will also be recorded.

  9. Maternal mental health in the post-partum period GAD-7

    Time frame: At 6 weeks and 6 months post delivery

    Assessment of maternal anxiety and depression symptoms using the Generalized Anxiety Disorder 7 questionnaire, where scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.

  10. Maternal mental health in the post-partum period using PHQ-9 survey

    Time frame: At 6 weeks and 6 months post delivery

    Assessment of maternal anxiety and depression symptoms using the Patient Health Questionnaire 9, where scores 5, 10, 15, and 20 represent cut-off points for mild, moderate, moderately severe, and severe depression, respectively.

  11. Maternal & Infant Health-related quality of life using AQoL-4D

    Time frame: At 6 weeks and 6 months post delivery

    The Assessment of Quality of Life Measure AQoL-4D questionnaire will be used to capture mother's and infants quality of life.

  12. Maternal & Infant Health-related quality of life using TANDI

    Time frame: At 6 weeks and 6 months post delivery

    The Toddler and Infant questionnaire will be used to capture infant health-related quality of life

  13. Infant growth up to 12 months

    Time frame: At 4, 8 and 12 months of age

    Infant weight at hospital discharge, 4, 8 and 12 months of age (self-reported)

  14. Maternal metabolic health

    Time frame: At pre-birth, 6 and 12 months post delivery

    Maternal weight (self-reported)

  15. Maternal metabolic health

    Time frame: At 6-8 weeks after delivery

    By assessing maternal glucose tolerance test

  16. Infant cow's milk allergy using Questionnaires

    Time frame: At 6 and 12 months

    Using an electronic survey asking about the symptoms related to cow's milk allergy

  17. Infant cow's milk allergy using SPT

    Time frame: At 6 and 12 months

    More assessment will done using a skin prick test if required to confirm allergy status

  18. Infant cow's milk allergy using OFC challenge

    Time frame: At 6 and 12 months

    Infants with a positive skin test will be further invited for an oral food challenge assessment, if required, to confirm allergy status

  19. Infant antibiotic use in the first 12-months of life

    Time frame: At 6 weeks, 6 and 12 months

    By assessing the parent's reports on the use of antibiotics

  20. Proportion of infants hospitalised with an infection in the first year of life

    Time frame: At 6 weeks, 6 and 12 months of age

    By assessing the parents' report for -

    • Antibiotic use in the first 12 months of life
    • Hospitalisation for infection in the first 12 months of life

Other outcomes

  1. Exploratory outcomes: To explore the experience of supplementing using Pasteurised donor milk supplementation

    Time frame: At 6 week to 3 months

    To explore and understand the Stakeholder experience of PDHM (parents in both arms of trial; staff including midwives, lactation consultants, neonatologists, neonatal nurses, obstetricians, managers) using in depth parent interviews and non-participant interviews.

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Koplin, PhD

CONTACT

[email protected]

061+0400032577

Vanessa Clifford, PhD

CONTACT

[email protected]

061+0437 527 044

Sponsors and collaborators

Lead sponsor

The University of Queensland

Other

Collaborators

  • Australian Red Cross Lifeblood
  • Frances Perry House (Ramsay Health)
  • La Trobe University
  • Monash University
  • Murdoch Childrens Research Institute
  • Ramsay Hospital Research Foundation
  • South Australian Health and Medical Research Institute
  • The Royal Women Hospital
  • University of Melbourne

Registry information

Official study title

A Randomised Controlled Trial of Pasteurised Donor Human Milk as Supplementary Nutrition for Infants Born to Women With Diabetes in Pregnancy.

Acronym: PRESENT

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 28, 2025
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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