A clinical trial led by researchers at the South Australian Health and Medical Research Institute (SAHMRI), the University of Adelaide and the Women’s and Children’s Hospital has been presented with the 2018 Australian Clinical Trials Alliance’s (ACTA) ‘Excellence in Trial Statistics’ award. The N3RO clinical trial investigated whether giving preterm infants born less than 29 weeks’ gestation an extra supply of the omega-3 docosahexaenoic acid (DHA) improves important respiratory outcomes associated with being born early.
The ACTA National Tribute and Awards Ceremony, held in celebration of International Clinical Trials Day, was established in 2016 to recognise and celebrate the outstanding achievements of ACTA members who advance clinical practice and save or improve the lives of patients every year through collaborative, multicentre, investigator-driven clinical trials.
A landmark trial
The N3RO Trial was awarded the prestigious ‘Excellence in Trial Statistics’ honour based on the outstanding quality of the statistical design and analysis. N3RO, published in the New England Journal of Medicine, showed that giving the extra DHA to these very preterm babies had no effect on lung disease, and in fact may increase the risk.
Dr Thomas Sullivan, the statistician for N3RO from the University of Adelaide, highlighted the importance of statistical design and analysis to the translation of research findings.
“If a trial is poorly designed or the data aren’t analysed in the right way, the results may not be trusted by the medical community, and ultimately it is the patients who lose out,” he said.
Results to shape the future of interventions for preterm babies
Dr Carmel Collins (N3RO lead investigator) from SAHMRI’s Healthy Mothers, Babies and Children theme and Senior Research Fellow at the University of Adelaide, said that the results of N3RO were landmark findings that will shape the future of testing all nutritional interventions for babies, because previously, DHA was thought to be beneficial for very premature babies with no harmful effects.
“We are delighted and honoured that this trial has been acknowledged by ACTA. N3RO addressed a critical evidence gap, and will impact on policy and practice, and shows how important it is to undertake properly designed studies. We believe that work like this will improve health outcomes for preterm babies, both in Australia and internationally,” Dr Collins said.
“The partnership between SAHMRI, the University of Adelaide and the Women’s and Children’s Hospital continues to see major results, and we are very fortunate to work in this collaboration.”