The benefits of donor milk for pre-term babies will be studied over the next five years as part of a $2.2 million trial funded by Australia’s National Health and Medical Research Council.
Across multiple neonatal centres in South Australia, Queensland and New South Wales, families of moderate to late preterm babies born 4-8 weeks early will be invited to participate in the trial testing the health and economic effects of receiving pasteurised donor milk, rather than cow’s milk formula.
The researchers behind the GIFT study are hoping the program will shed light on whether donor milk helps to reduce complications of feeding, improve a baby’s growth and reduces the duration preterm children need to spend in hospital.
Evidence in favour of providing preterm babies with donor milk may lead to changes as part of routine care.
Around 25,000 babies are born prematurely each year – most are within the moderate to late preterm range, which the trial will investigate.
“We think there are substantial benefits of donor milk,” says the study’s co-leader Associate Professor Alice Rumbold, a perinatal epidemiologist and researcher at the South Australian Health and Medical Research Institute.
“Babies who are born really early – that’s before 32 weeks of pregnancy – they’re already given donor milk when their mother’s milk is not available or is in short supply.
“There’s clear evidence in those babies that use of donor milk instead of formula reduces the risk of a really serious complication called necrotising enterocolitis.”
Necrotising enterocolitis irritates the gut in early preterm babies; it’s less often seen in those in the cohort Rumbold will study.
But she says formula has sometimes led to gut irritation in moderate to late preterm babies. This can cause feeding intolerance that may lead to vomiting and bloating.
“So we believe using donor milk will actually reduce that gut irritation, potentially reducing the risk of feed intolerance and other feeding complications in hospital,” Rumbold says.
“We expect that [donor milk] will help really reduce the risk of feeding difficulties and poor growth in those first few weeks of life, but we also expect that it will help the transition to full breastfeeding.”
Making sure the white stuff is the right stuff for preterm infants
In partnership with Lifeblood – the blood donation arm of the Red Cross in Australia – Rumbold and her colleagues will acquire hundreds of litres of donated milk from across the country.
But just as blood is closely vetted before nurses stick a needle in the arms of willing donors, so too do volunteer breast milk donors receive thorough checks to ensure the best possible product is collected.
After checking themselves against eligibility criteria, potential donors undergo a comprehensive screening.
“Just to make sure that there’s absolutely nothing in their lifestyle choices that would be it would be ineligible or unsafe for them to donate their breast milk,” says Lifeblood’s Milk Operations Manager Chris Sulfaro.
Collection starts at 4-6 weeks after childbirth.
That ensures that their newborn receives all the colostrum – first milk – released by the mammary glands. Colostrum changes quickly, and it’s important that a child receives it from their own mother before expressing for donation can commence.
But donation nurses also want to avoid disrupting early connections between the donor and their own child.
“First and foremost, we support these donors with feeding their own baby. We’re very ethical in making sure that the milk that they’re giving us is excess to their own baby’s needs, that’s our primary priority and concern, not to put the donor’s own baby at risk,” Sulfaro says.
A single donor might participate in the program once, or continuously from four weeks to their child’s first birthday. Each donation is collected in the form of three-litre units every 10 weeks.
These are taken to a collection centre, refrigerated overnight, then mixed and dispensed into 30mL or 120mL bottles.
These samples are then heated to 62.5 degrees for half an hour to pasteurise the milk, ensuring live viruses and bacteria are inactivated.
Dr Laura Klein from Lifeblood, who is assisting the study, is hoping to build her organisation’s understanding of how their product can better support clinical outcomes.
Blood and milk products are supplied to institutions around the country for both medical and research outcomes, and Klein is particularly interested in seeing whether the limited evidence that exists on the benefits of donor milk for moderate to late preterm babies can be enhanced by this study.
“There’s less data out there about how donated breast milk or pasteurised donor human milk, can be used to support infants when their mum’s own milk isn’t available,” Klein says.
“I hope what our research does, and what our collaborations do, is help provide that evidence to help best use this product for infants when their mum’s own milk isn’t available.”
Clarification: The second paragraph of this story originally described moderate to late pre-term births as 4-8 months, it has been corrected to 4-8 weeks.