Pasteurised Donor Human Milk Supplementation for Term Babies

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.

Conditions

• Neonatal Hypoglycemia
• Metabolic Complication
• Cows Milk Allergy
• Hospital Length of Stay
• Neonatal Intensive Care Unit
• Breastfeeding
• Mental Health Issue

Interventions

OTHER

Standard care Cow's milk based formula

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

DIETARY_SUPPLEMENT

Dietary Supplement: PDHM Pasteurised Donor Human Milk

PDHM will be given to infants randomised to the intervention group

Sponsors & Collaborators

• Murdoch Childrens Research Institute

  collaborator OTHER

• La Trobe University

  collaborator OTHER

• University of Melbourne

  collaborator OTHER

• South Australian Health and Medical Research Institute

  collaborator OTHER

• Australian Red Cross Lifeblood

  collaborator UNKNOWN

• Monash University

  collaborator OTHER

• The Royal Women Hospital

  collaborator UNKNOWN

• Frances Perry House (Ramsay Health)

  collaborator UNKNOWN

• Ramsay Hospital Research Foundation

  collaborator UNKNOWN

• The University of Queensland

  lead OTHER

Principal Investigators

• Jennifer Koplin, PhD · Child Health Research Centre, University Of Queensland

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

0 Hours

Max Age

48 Hours

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-04

Primary Completion

2028-04-30

Completion

2028-12-31

Countries

• Australia

Study Locations