Pragmatic Randomized Trial of Corticosteroids and Inhaled Epinephrine for Bronchiolitis in Children in Intensive Care

Abstract

To determine whether the combination of systemic corticosteroids and nebulized epinephrine, compared with standard care, reduces the duration of positive pressure support in children with bronchiolitis admitted to intensive care. We performed a pragmatic, multicenter, open-label, randomized trial between July 2013 and November 2019 in children younger than 18months old with a clinical diagnosis of bronchiolitis. The intervention group received the equivalent of 13mg/kg prednisolone over 3days, then 1mg/kg daily for 3days, plus 0.05mL/kg of nebulized 1% epinephrine made up to 6ml with 0.9% saline via jet nebulizer and mask using oxygen at 12l/min every 30minutes for 5 doses, then 1-4 hourly for 3days, then as required for 3days. The primary outcome was clinician-managed duration of positive pressure support in intensive care defined as high-flow nasal-prong oxygen, nasopharyngeal continuous positive airway pressure, or mechanical ventilation. In total, 210 children received positive pressure support. In the corticosteroid-epinephrine group, 107 children received positive pressure support for a geometric mean of 26 (95% CI, 22-32) hours compared with 40 (95% CI 34-47) hours in 103 controls, adjusted ratio 0.66 (95% CI 0.51-0.84), P=.001. In the intervention group, 41 (38%) children experienced at least 1 adverse event, compared with 39 (38%) in the control group. In children with severe bronchiolitis, the duration of clinician-managed pressure support was reduced by regular treatment with systemic corticosteroids and inhaled epinephrine compared with standard care. Australian Clinical Trials Research Network: ACTRN12613000316707.