Interim analyses
BPD, death
RECRUITMENT
The DSMB have conducted multiple interim analyses for safety through the trial, and a single analysis for efficacy at the halfway point of recruitment when primary outcome endpoint data (death or BPD at 36 weeks’ PMA) were available for 530 infants (50% of the planned sample size). As per the PLUSS Trial DSMB Charter (version 2, 2019), “the DSMB may make a recommendation to cease the trial only in the presence of very strong (