Pasteurised Donor Human Milk Supplementation for Term Babies (PRESENT)

The University of Queensland

Status and phase: Enrolling; Phase 4

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

Treatments: Other: Standard care Cow's milk based formula; Dietary Supplement: Dietary Supplement: PDHM Pasteurised Donor Human Milk

Study type: Interventional

Funder types: Other

Identifiers

NCT06993103

2024607 (Other Grant/Funding Number)

2024-607

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,444 estimated patients

Sex: All

Ages: Under 48 hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,444 participants in 2 patient groups

PDHM - Pasteurised donor human milk

Experimental group

Description:

All infants in this group will get access to Pasteurised donor human milk (PDHM) as supplementary nutrition. PDHM will be made available to the intervention group from the time of randomisation until day 5 of life. Families will be provided with a sufficient supply of frozen PDHM for home use to ensure an exclusively human milk diet up to day 5 of life if their infant is discharged before day 5. Access to PDHM will cease after 120 hours of life, and the infant will be fed according to standard hospital protocols or as per parent's decision.

Treatment:

Dietary Supplement: Dietary Supplement: PDHM Pasteurised Donor Human Milk

Standard Care

Active Comparator group

Description:

All infants in this group will receive the standard care as per local unit policy, including supplemental nutrition (e.g. infant cow's milk formula or IV fluids) as recommended by the treating clinician

Treatment:

Other: Standard care Cow's milk based formula