Clinical Trial Finder

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

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.

Arms

Experimental: PDHM - Pasteurised donor human milk

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.

Active Comparator: Standard Care

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

Interventions

Dietary Supplement: - 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