Background: The efficacy of inhaled steroids in spontaneously breathing infants with "new" bronchopulmonary dysplasia (BPD) is debatable. The inhaled steroid hydrofluoalkane-beclomethasone dipropionate (QVAR) is unique in its small particle size that results in higher lung deposition and was not studied previously in BPD.
Objective: To determine if inhaled QVAR will be effective in alleviating the morbidity of BPD compared to placebo.
Design/Methods: Prospective, double blind, randomized placebo-control, multi-center study. Preterm infants with moderate to severe BPD were randomized to inhaled QVAR (IVAX Pharmaceuticals, London, England) 100 µg dose or placebo twice daily via aerochamber with face mask. Treatment was administered daily from recruitment at 36 weeks post menstrual age until 3 months post discharge.
Results: The study (n=18) and placebo (n=20) groups had comparable characteristics at birth and recruitment. Study vs. placebo groups were comparable in length of stay (108.5±26.3 vs. 108.7±36.0 days), infants requiring oxygen at discharge (5/17 vs. 6/19) or at study end (0/17 vs. 2/19), respiratory rehospitalizations (5/17 vs. 8/19), rehospitalization days (1.1±2.7 vs. 4.1±10.3), additive inhaled steroids (0.3±1.0 vs. 6.4±21.5 days), systemic steroids (0.7±2.9 vs. 1.0±4.4 days), and total additive (inhaled/systemic) steroids (1.0±2.9 vs. 7.8±26.4 days). Out of the placebo group, 1 infant died before discharge (sepsis), and 2 were admitted to PICU for bronchiolitis (RSV and Parainfluenzae). Blood pressure, height and weight were comparable between groups during the study.
Conclusions: Inhaled QVAR compared with placebo did not affect significantly the respiratory course of moderate/severe BPD until discharge or during the following 3 months period.
