A successful international clinical trial coordinated and run from the University of Tasmania’s Menzies Institute for Medical Research has recently had its two-year follow-up results published in the prestigious Journal of the American Medical Association (JAMA).
Professor Peter Dargaville led the study, which was conducted in thirty-three neonatal intensive care units in eleven countries. Today he was reunited with Eva, a healthy three-year-old he had treated soon after her birth at 27 and a half weeks’ gestation, three months earlier than full term.
The OPTIMIST-A trial examined the effect of an innovative method for delivering surfactant, a natural product that promotes lung expansion and improves oxygen levels in premature infants.
486 premature babies around the world were enrolled in the OPTIMIST-A trial in the first hours of life, making it the largest study of this type ever conducted. The trial examined the effect of delivery of surfactant via a thin tube or catheter using the novel Hobart method, developed by Professor Dargaville and his team. The aim was to improve upon the current standard of care, seeking to limit the development of bronchopulmonary dysplasia (BPD), a chronic disease of the lung that can have lasting effects on the lives of preterm infants.
Professor Dargaville said the new paper reported the two-year outcomes for preterm infants recruited into the trial, in which outcomes were compared in an active treatment group receiving surfactant via the Hobart method and a control group.
“In the follow-up study we found no differences in neurodevelopmental outcome at 2 years of age, but a clear difference favouring the active treatment group for respiratory health in the first two years. There was a one-third reduction in the rate of hospitalisation with a respiratory illness, and also reductions in the rate of wheezing or breathing difficulty reported by parents, use of bronchodilator therapy, and a physician report of asthma.”
“The lasting effect on respiratory health that was found after a single intervention performed in the first hours of life is a major advance, and one that cements the place of this new form of surfactant therapy using a thin catheter in preterm infants,” Professor Dargaville said.
“The fact of there being no difference in neurodevelopmental outcome is also important, as it confirms the safety of the novel method of surfactant delivery.”
Sarah de Jong, Eva’s mother, said they were approached by Professor Dargaville to take part in the OPTIMIST-A trial.
“Mark and I didn’t hesitate - if this was a chance to help Eva we gladly accepted.”
“During our nine week stay at the Royal Hobart hospital, we took part in three medical trials that have all been successful.”
“We are very thankful for the opportunity to be a part of such a great program. We now have an extremely healthy daughter all thanks to a huge team of people who helped Eva through her journey.”
The OPTIMIST-A trial is the largest study to examine the effect of surfactant therapy via a thin catheter with any comparator, one of few blinded studies, and one of few to report follow-up outcomes. The study was coordinated and run from Menzies, supported by our local Royal Hobart Hospital Research Foundation and the National Health and Medical Research Council.