A successful international clinical trial that included Children’s Regional Hospital at Cooper recently had its two-year follow-up results published in the prestigious Journal of the American Medical Association (JAMA).
Alla Kushnir, MD, FAAP, a neonatologist at Children’s Regional Hospital at Cooper and Director for both the Center for Fetal Care and Pediatric Research at Cooper, served as one of the co-authors and was the site principal investigator for the study, which was conducted in 33 neonatal intensive care units in 11 countries.
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.
The OPTIMIST-A trial enrolled 486 premature babies around the world in their 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 Peter Dargaville, the trial lead investigator, and his team at Royal Hobart Hospital in Australia. 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.
Dr. Kushnir said the new paper reported the two-year outcomes for the preterm infants in the trial, comparing outcomes in the active treatment group that received surfactant via the Hobart method and a control group.
“In the follow-up study we found no differences in neurodevelopmental outcome at two years of age, but a clear difference favoring the active treatment group for respiratory health in the first two years. There was a one-third reduction in the rate of hospitalization with a respiratory illness, and reductions in the rate of wheezing or breathing difficulty reported by parents, use of bronchodilator therapy, and a physician report of asthma,” said Dr. Kushnir.
“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,” Dr. Kushnir said. “The fact there is no difference in neurodevelopmental outcome is also important, as it confirms the safety of the novel method of surfactant delivery.”
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, Australia, supported by the Royal Hobart Hospital Research Foundation and the Australian National Health and Medical Research Council.