INHALED SALBUTAMOL AND BECLOMETHASONE FOR PREVENTING BRONCHOPULMONARYDYSPLASIA - A RANDOMIZED DOUBLE-BLIND-STUDY

Early inflammatory lesions and bronchial hyperresponsiveness are chara cteristics of the respiratory distress in premature neonates and are s usceptible to aggravation by assisted ventilation. We hypothesized tha t treatment with inhaled salbutamol and beclomethasone might be of cli nical value in the prevention of bronchopulmonary dysplasia (BPD) in v entilator-dependent premature neonates. The study was double-blinded a nd placebo controlled. We studied 173 infants of less than 31 weeks of gestational age, who needed ventilatory support at the 10th postnatal day. They were randomised to four groups and received either placebo + placebo, placebo + salbutamol, placebo + beclomethasone or beclometh asone + salbutomol, respectively for 28 days. The major criteria for e fficacy were: diagnosis of BPD (with score of severity), mortality, du ration of ventilatory support and oxygen therapy. The trial groups wer e similar with respect to age at entry (9.8-10.1 days), gestational ag e (27.6-27.8 weeks), birth weight and oxygen dependence. We did not ob serve any significant effect of treatment on survival, diagnosis and s everity of BPD, duration of ventilatory support or oxygen therapy. For instance, the odds-ratio (95% confidence interval) for severe or mode rate BPD were 1.04 (0.52-2.06) for inhaled beclomethasone and 1.54 (0. 78-3.05) for inhaled salbutamol. Conclusion This randomised prospectiv e trial does not support the use of treatment with inhaled beclomethas one, salbutamol or their combination in the prevention of BPD in prema ture ventilated neonates.