The impact of inhaled bronchodilators on bronchopulmonary dysplasia: a nonrandomized comparison from the NEuroSIS trial

Abstract

Abstract Background: Inhaled bronchodilators improve pulmonary function. Their effects on bronchopulmonary dysplasia (BPD) are uncertain. We assessed the efficacy of early inhaled bronchodilators on the risk of BPD and death in extremely preterm infants. Methods: We performed a post-hoc analysis of prospectively collected data from the Neonatal European Study of Inhaled Steroids (NEuroSIS). In NEuroSIS, 863 extremely preterm infants were randomly assigned to receive early inhaled budesonide or placebo. We now performed nonrandomized comparisons between infants that participated in the NEUROSIS trial and either received early (within the first 48\u2009h of life) bronchodilators or no bronchodilators. Groups were assembled according to predefined criteria stated in the study protocol and we used the same prespecified primary outcome as in the main study, a composite of BPD and death at a postmenstrual age of 36 weeks. Results: Treatment groups did not differ significantly in the composite outcome of BPD and death at 36 weeks postmenstrual age: bronchodilator group (20/46; 43.5%), versus 349/810 (43.1%) in the no bronchodilator group; (p = .97). Analyzed by individual components, there were no significant differences in BPD and death rates between the groups. Discussion: Based on our analyses, early inhaled bronchodilators did not reduce the risk of BPD and death in extremely preterm infants.