Supplemental Oxygen Strategies in children with BronchoPulmonary Dysplasia (the SOS BPD study): statistical analysis plan for a multicenter randomized controlled trial

Supplemental oxygen remains the primary treatment for preterm infants with established bronchopulmonary dysplasia (BPD). Although randomized controlled trials have evaluated lower versus higher oxygen saturation targets in preterm infants before 36 weeks postmenstrual age, evidence beyond this age is lacking. The aim of the Supplemental Oxygen Strategies in children with BronchoPulmonary Dysplasia (SOS BPD) study is to evaluate the effect of a higher oxygen saturation lower limit of 95%, compared with a lower limit of 90%, on lung growth by proxy of weight standard deviation score (SDS), at 6 months corrected age in infants with established BPD. This document outlines the statistical analysis plan for the SOS-BPD study. The SOS BPD study is a multicenter, pragmatic, non-blinded, randomized trial in preterm infants with moderate or severe BPD. Eligible infants are randomized between 36 and 38 weeks postmenstrual age to a lower oxygen saturation limit of 95% or 90%, after parental informed consent. The assigned oxygen saturation lower limit is maintained until respiratory support can be discontinued. The primary outcome is weight SDS at 6 months corrected age. Secondary outcomes include anthropometrics measured at 6 and 12 months corrected age, rehospitalizations for respiratory reasons and respiratory complaints. This statistical analysis plan is written and submitted without knowledge of the data. Overview of Medical Research in the Netherlands (OMON), NL-OMON54694. Registered on 09-08-2018, URL: https://onderzoekmetmensen.nl/en/trial/54694 .