None listed
Conditions
Brief summary
Babies that are born too soon (preterm) are at risk of slow growth and delayed development. This can affect lifelong health. Exclusive breastfeeding and use of breast milk is a key way to improve outcomes for babies born preterm but these babies often have problems breastfeeding and their mothers can find it hard to produce enough milk, especially in the first few weeks after birth. As a result, many are given infant formula, which can be difficult to digest and is sometimes harmful to preterm babies as they are born before their gut is fully developed. Feeding babies with pasteurised donor human milk has been shown to improve health outcomes for babies born very early but we do not know if it benefits babies born just a few weeks early (moderate to late preterm). The primary aim of this randomised controlled trial is to determine whether using donor human milk, instead of infant formula, in the critical early weeks after birth improves nutrition and growth of moderate to late preterm infants, and supports their mothers to continue breastfeeding in the first 6 months after birth. The trial will be conducted in partnership with Australian Red Cross Lifeblood.
Interventions
Pasteurised donor human milk, supplied by Australian Red Cross Lifeblood.
Infants will be fed with maternal breast milk each day (if available) and then supplemented with pasteurised donor human milk in a volume as determined by the treating health care team, based on the target volume of 150ml/kg/day or as specified in local unit protocols.
Infants will receive pasteurised donor human milk for up to 8 days, but this may be ceased earlier if maternal breast milk supply is sufficient to feed
Pasteurised donor human milk, supplied by Australian Red Cross Lifeblood. Infants will be fed with maternal breast milk each day (if available) and then supplemented with pasteurised donor human milk in a volume as determined by the treating health care team, based on the target volume of 150ml/kg/day or as specified in local unit protocols. Infants will receive pasteurised donor human milk for up to 8 days, but this may be ceased earlier if maternal breast milk supply is sufficient to feed at a rate of 150ml/kg/day OR if the infant is discharged. Adherence to the intervention will be monitored by review of fluid balance charts held in the infant medical record.
Sponsors
South Australia Health and Medical Research Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
0 to 4 Days
Healthy volunteers
No
Inclusion criteria
Eligible infants must meet all of the following criteria: 1. 32+0 and 36+6 completed weeks’ gestation at birth; 2. Birth weight 1500g or more; 3, Admitted to the neonatal unit; 4. Clinically stable; 5. Ready to commence enteral feeds or commenced enteral feeds with human milk but insufficient maternal breast milk is available; 6. Aged less than or equal to 4 days old; 7. Has a parent or guardian capable of giving informed consent.
Exclusion criteria
An infant who meets any of the following criteria will be excluded from participation: 1. Metabolic disorder that precludes breastfeeding; 2. Major congenital malformation either likely to interfere with the ability to ingest milk or requiring surgery in the first 6 months of life; 3. Given infant formula prior to randomisation.
Outcome results
None listed