Background Survival of extremely low birth weight (ELBW) infants has improved in recent decades but bronchopulmonary dysplasia (BPD) remains a major problem. The effect of early inhalation of corticosteroids on survival without BPD in these infants is unclear.
Objective To determine the effect of early use of inhaled budesonide in infants with gestational ages of 23 0/7–27 6/7 weeks requiring any form of positive pressure support on survival without BPD at 36 weeks’ gestational age.
Methods Randomised controlled trial. Budesonide or placebo were continued until infants were either off supplementary oxygen and positive pressure support or had reached a gestational age of 32 0/7 weeks regardless of their ventilator status. The primary outcome was death before 36 weeks of gestational age or survival with BPD, defined according to the physiological definition.
Results We randomly assigned 863 infants during the first 12 h of life in 40 centres in 9 countries to inhaled budesonide or placebo. In 7 infants consent was withdrawn. Of the 437 infants assigned to inhaled budesonide, 175 died or survived with BPD (40.0%), as compared with 194 of 419 infants assigned to placebo (46.3%). Further results are shown in the table.
Conclusions The reduction of the primary outcome (death before 36 weeks or BPD) by inhaled budesonide in ELBW infants was of borderline statistical significance. Inhaled budesonide significantly reduced BPD, which is a component of our primary outcome and was a predefined secondary outcome.