Last week was a wonderful week for clinical trials in Australia, particularly neonatal trials.
On Friday 20th May, the annual Clinical Trials 2017 National Tribute and Awards Ceremony was held by the Australian Clinical Trials Alliance (ACTA) at Royal Prince Alfred Hospital celebrating the outstanding achievements of Australian clinical trials and honouring the people who make them possible.
Presented by Hon. Greg Hunt MP, the Runner Up to the 2017 ACTA Trial of the Year was awarded to the BOOST II Trial - a randomised controlled trial to investigate the effect of two slightly different oxygen levels on the health of very premature infants.
Most very preterm babies need extra oxygen, because their lungs are immature. Too much oxygen may harm their eyes, (sometimes causing blindness) and too little reduces their chance of healthy survival. For 50 years, doctors and nurses have had no good evidence about the best level of oxygen for very preterm babies. Until recently, the accepted range was between 85-95% saturation.
BOOST II was led by the Interdisciplinary Maternal Perinatal Australasian Collaborative Trials (IMPACT) Network, and coordinated by the National Health and Medical Research Council (NHMRC) Clinical Trials centre to study this question in 1200 very preterm babies. It was one of five similar studies around the world – called the NeoPrOM Collaboration - designed to find out if aiming for lower (85-89%) or higher (91-95%) blood oxygen, both within the accepted range, improved healthy survival.
Parents of nearly 5,000 babies worldwide joined this unique effort - in Australia, NZ, UK, US, Canada and 10 other countries with 1,135 babies enrolled in BOOST II Australia.
This global collaboration showed that, for every 1000 very preterm children treated with oxygen, 28 more lives will be saved by aiming for 91-95% saturation instead of 85-89% - with no increase in blindness or disability.
“This evidence will save thousands of lives, at minimal cost,” commented BOOST II Australia co-ordinator, William Tarnow-Mordi, Director of Neonatal and Perinatal Trials, at the WINNER Centre, NHMRC Clinical Research Centre, University of Sydney. “It was made possible by the wholehearted support of parents and researchersand their collaborating teams – and by dedicated people like them all over Australia,” he added.
Although Australia’s population of 24 million is only 5% of the total population of 445 million of all five countries, BOOST II Australia enrolled 23% of all 4,965 infants in NeoPrOM.
This illustrates the strong, collaborative ethos of Australian trials research in contributing to groundbreaking evidence that will increase healthy life expectancy for millions of the world’s most vulnerable children, at minimal cost.
King Edward Memorial Hospital, Perth, was a major contributor to BOOST II Australia. Work is in progress to follow up the children in the study during early childhood.
As a parent of three preterm babies, I understand the incredible need for research and commend the valuable collaboration between researchers, doctors, nurses and the parents who said yes to their baby's participation. This study will have a huge global impact on newborn babies who are born very preterm and as parents, we understand that saying yes to a trial may not help our baby but may help future babies like ours.
I am immensely proud of Miracle Babies Foundation's small contribution to BOOST II and to the overall commitment to help change community culture so that one of the first questions future parents ask their doctor is ‘Are there any clinical trials I can join?'