Intratracheal budesonide mixed with surfactant to increase survival free of bronchopulmonary dysplasia in extremely preterm infants: statistical analysis plan for the international, multicenter, randomized PLUSS trial

Abstract

Abstract The PLUSS trial is a multicenter, two-arm, parallel, double-blind, randomized controlled trial, enrolling at least 1060 extremely preterm infants in 21 participating hospitals across four countries (Australia, New Zealand, Canada and Singapore). Enrolment commenced in January 2018 and was completed in March 2023. The trial is investigating whether intratracheal budesonide (a corticosteroid) combined with surfactant, compared to surfactant alone, will increase survival free of bronchopulmonary dysplasia (BPD) in extremely preterm infants.