$2.2m for donor milk trial for pre-term babies

More than 2000 pre-term babies will participate in a donor breast milk trial funded as part of a $73 million National Health and Medical Research Council (NHMRC) Clinical Trials and Cohort Studies (CTCS) Grant round.

Associate Professor Alice Rumbold and Associate Professor Amy Keir from The University of Adelaide and the South Australian Institute of Health and Medical Research (SAHMRI) and collaborators will receive over $2.2 million for their donor milk study known as the GIFT Trial.

The researchers will compare the health and economic impacts of using pasteurised donor human milk (donor milk) versus infant formula as a source of nutrition for babies born between 32 and 36 weeks of pregnancy.

The project team will partner with Australian Red Cross Lifeblood to conduct a randomised controlled trial at five sites in three states.

The randomised trial involving over 2,100 babies born moderate to late preterm aims to determine whether the use of donor milk instead of infant formula as a supplement to maternal breast milk reduces the time spent in hospital after birth. If donor milk does help babies get home sooner, and with fewer feeding-related complications, it would benefit the infants, their families and the health system.

CTCS grants support high-quality clinical trials and cohort studies that address important gaps in knowledge, leading to relevant and implementable findings for the benefit of human health.

Quotes attributable to Associate Professor Alice Rumbold, The University of Adelaide and SAHMRI 

 “This grant builds on several years of pilot research by SAHMRI in collaboration with Australian Red Cross Lifeblood and maternity hospitals in South Australia and Queensland.

“We are delighted to receive funding to undertake a large randomised trial involving over 2,100 babies born moderate to late preterm.

“This will provide crucial evidence to determine whether use of donor milk, as a supplement to maternal breast milk, reduces time spent in hospital, feeding difficulties and feeding-related complications, which are common in these vulnerable babies.  

“Currently, babies who are born very early (before 32 weeks of pregnancy) are given pasteurised donor human milk (donor milk) when their own mother’s milk is not available or in short supply.

“Whether donor milk is beneficial for babies born just a few weeks early is unclear, as very little research has been undertaken with these babies.

“We will conduct a trial to determine whether use of donor milk as a supplement to maternal breast milk improves health outcomes for babies born 4 to 6 weeks early and helps to reduce the time they spend in hospital after birth.

“Complications due to poor feeding are the major cause of health burden and costs in babies born moderate to late preterm (32 to 36 weeks of pregnancy).

“The goal of our research is to establish whether use of supplemental donor milk reduces the need for prolonged hospitalisation after birth and reduces feeding-related complications in these babies.

“Ultimately, this will determine whether donor milk, which is currently prioritised for babies born very preterm (before 32 weeks of pregnancy), should be made available to all babies born early, when maternal breast milk is not available or in short supply.”

Background information

Babies born 4 to 6 weeks before their due date (moderate to late preterm) often have trouble feeding and most need extra nutrition while breastfeeding is established.

Infant formula is regularly used as additional nutrition for pre-term babies, but it can contribute to complications, including feeding intolerance, increased need for IV fluids, interrupted breastfeeding, effects on weight gain and delayed hospital discharge.

Human milk is easier to digest than formula and protects babies against other serious diseases and infections. It has all the nutrients babies need for their growth and development.

Australian Red Cross Lifeblood is funded by Australian governments to provide life-giving blood, plasma, and transplantation and biological products.