Led by the University of Sydney, the project has just received $2.2 million in funding and will take place in intensive care units in Australia, New Zealand and the United States.
“In Australia it will be the first time in a multicentre clinical trial with babies that parents will act as full partners in all aspects,” said Professor William Tarnow-Mordi, from the Sydney Medical School at the University and director of the WINNER Centre for Newborn Research at Westmead Hospital.
Professor Tarnow-Mordi is leading the trial, which was funded in the latest round of National Health and Medical Research Council grants.
The randomised trial is to confirm if bovine lactoferrin, an inexpensive dairy protein, increases survival without complications and enhances total breast milk intake in premature or very low birthweight babies in neonatal intensive care units.
In randomised trials, half the babies get the new treatment and half do not. The current trial will test previous results from Italy which suggest that lactoferrin may reduce infection and other complications in babies born with a birthweight less than 1.5 kilograms.
“Two parents will serve on the trial management committee – the body which will oversee every detail of how the trial is conducted,” Professor Tarnow-Mordi said.
“We will also involve a wide range of parent groups both in developing information on the trial and informing parents of the results. We hope that knowing that the trial has been endorsed by other parents will lead to faster recruitment and completion of the trial and help get the results into practice more quickly. “
Melinda Cruz, CEO of Miracle Babies Foundation, a national parent support and advocacy group, said: “We are thrilled to be playing a key role in this important study, which could make a big difference in the chances of healthy survival for hundreds of premature babies born in Australia every year.”
“Parents can bring many benefits to research. They can improve the aims and focus of the trial, help produce better, clearer information and strengthen public understanding and support,” said Cruz.
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