RTI supports major neonatal trial on budesonide and lung disease in preterm infants

The trial results, published in JAMA, revealed no benefit in combining budesonide with surfactant to prevent bronchopulmonary dysplasia

RESEARCH TRIANGLE PARK, N.C. — In a major multicenter clinical trial done by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Neonatal Research Network (NRN), researchers found that adding the steroid medication budesonide to surfactant, a natural substance that helps the lungs stay open that is routinely given to extremely premature newborns, did not reduce their risk of bronchopulmonary dysplasia (BPD) or death.

Independent scientific research institute RTI International served as the data coordinating center for the trial, providing biostatistical leadership, informatics and data management, and logistical support and coordination, with Kayla Nowak as lead statistician. Researchers from the University of Alabama at Birmingham (UAB) led the trial.

“Despite promising results from smaller studies, these findings show that combining budesonide with surfactant does not improve outcomes for extremely preterm infants with BPD, a serious lung condition that affects premature infants who need breathing support,” said Abhik Das, Ph.D., Distinguished Fellow and principal investigator for RTI.

“This study offers essential evidence to inform and improve neonatal care practices,” added Dr Namasivayam Ambalavanan, lead author and clinical investigator from UAB.

The randomized clinical trial enrolled 641 infants born before 29 weeks’ gestation across 17 U.S. centers. The trial was halted early after reaching a pre-specified threshold that indicated that continuing the study was unlikely to show benefit. The incidence of BPD or death was nearly identical between the budesonide plus surfactant group (68.5%) and the surfactant only group (67.9%).

The study was conducted under an Investigational New Drug application approved by the U.S. Food and Drug Administration and followed rigorous protocols including double-masking and stratified randomization.

The trial complements findings from the PLUSS trial, a similar study conducted in Australia, Canada, New Zealand and Singapore, which also found no benefit from the budesonide-surfactant combination.

Findings were published in the Journal of the American Medical Association (JAMA).

Read the full study

Learn more about RTI’s coordinating center capabilities