Early inhaled steroid use in extremely low birthweight infants: a randomised controlled trial

Objective We hypothesised that a prophylactic inhaled steroid would prevent the progression of bronchopulmonary dysplasia (BPD) in extremely low birthweight infants (ELBWIs). Design This study was a multicentre, randomised, double-blinded, placebo-controlled trial. Setting This investigation was conducted in 12 level III neonatal intensive care units (NICUs). Patients A total of 211 ELBWIs requiring ventilator support were enrolled. Intervention Starting within 24 h of birth and continuing until 6 weeks of age or extubation, two doses of 50 μg fluticasone propionate (FP) or placebo were administered every 24 h. Main outcome measurement The primary outcome measure used to indicate the morbidity of severe BPD incidence was death or oxygen dependence at discharge from the NICU. The secondary measures were neurodevelopmental impairments (NDIs) at 18 months of postmenstrual age and 3 years of age. We performed subgroup analyses based on gestational week (GW) and the presence of chorioamnionitis (CAM). Results Infants were randomised into the FP (n=107) or placebo (n=104) groups. No significant differences were detected between the FP and placebo groups with respect to either the frequency of death or the oxygen dependence at discharge or NDIs. In subgroup analyses, the frequencies of death and oxygen dependence at discharge were significantly decreased in the FP group for infants born at 24–26 GWs and for infants with CAM, regardless of the GW at birth. Conclusions Inhaled steroids have no effect on the prevention of severe BPD or long-term NDI but might decrease the severity of BPD for ELBWIs with a risk factor. Trial registration number UMIN-CTR C000000405.