2023 Department of Pediatrics Academic Annual Report

Treatment Effects of Hydrocortisone by Risk of Bronchopulmonary Dysplasia or Death Among Extremely Preterm

by Heather Watts

Extremely preterm infants who develop bronchopulmonary dysplasia (BPD) are at a higher risk for adverse pulmonary and neurodevelopmental outcomes. Hydrocortisone has been considered as a potential therapy to prevent development of BPD. However, in the recently conducted National Institute of Child Health and Human Development (NICHD) Neonatal Research Network (NRN) Hydrocortisone Trial, hydrocortisone exposure did not reduce rates of BPD or death compared to placebo. The trial enrolled infants between August 22, 2011, and February 4, 2018, born at a gestational age of less than 30 weeks who received mechanical ventilation for at least seven days. Researchers at UAB, led by Sam Gentle, M.D., assistant professor in the Division of Neonatology, conducted a secondary analysis to evaluate whether a subpopulation of infants benefitted from hydrocortisone treatment. The team analyzed data from the NICHD NRN trial for this study. The original study was a double-masked, placebo controlled, randomized clinical trial conducted in 19 US academic centers. Dr. Gentle used the NICHD

Neonatal BPD Outcome Estimator to estimate the infants’ baseline risk of grades 2 to 3 BPD or death and then reanalyzed subpopulations to assess potential benefit. The analysis of these data revealed that the infants’ baseline risk for BPD (e.g., whether it was high or low) did not modify the impact of hydrocortisone on the development of BPD. Since only hydrocortisone was assessed in the original study, the potential benefit of other steroids on BPD outcomes was not assessable. “Hydrocortisone, used either selectively or non-selectively, may not be the appropriate corticosteroid to reduce BPD or death in extremely preterm infants. Additional trials of alternative corticosteroid exposure strategies may still be warranted,” explained Gentle, principal investigator on the study. ■

This study was published in JAMA Network Open in May 2023. Namasivayam Ambalavanan, M.D., professor in the Division of Neonatology, and Waldemar A. Carlo, M.D., professor in the Division of Neonatology, are co-authors with Dr. Gentle.

2023 Academic Annual Report

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