Inhaled salbutamol and beclomethasone for preventing broncho-pulmonary dysplasia: a randomised double-blind study

• Type: Article in International Scientific Journal
• Date: 1998

Authors

Denjean, A (Author) Other; Paris Llado, J (Author) Other; Zupan, V (Author) Other; Debillon, T (Author) Other; Kieffer, F (Author) Other; Magny, JF (Author) Other; Desfreres, L (Author) Other; Llanas, B (Author) Other; Guimarães H (Author) FMUP; Moriette, G (Author) Other; Voyer, M (Author) Other; Dehan, M (Author) Other; Breart, G (Author) Other

Journal

Title: European Journal of Pediatrics

Vol. 157

Pages: 926-931

ISSN: 0340-6199

Publisher: Springer Nature

Indexing

ISI Web of Knowledge - 49 Citations

Scopus - 61 Citations

Other information

Authenticus ID: P-001-6TK

DOI: 10.1007/s004310050969

Abstract (EN): Early inflammatory lesions and bronchial hyperresponsiveness are characteristics of the respiratory distress in premature neonates and are susceptible to aggravation by assisted ventilation. We hypothesized that treatment with inhaled salbutamol and beclomethasone might be of clinical value in the prevention of bronchopulmonary dysplasia (BPD) in ventilator-dependent premature neonates. The study was double-blinded and 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 beclomethasone + salbutomol, respectively for 28 days. The major criteria for efficacy were: diagnosis of BPD (with score of severity), mortality, duration of ventilatory support and oxygen therapy. The trial groups were similar with respect to age at entry (9.8-10.1 days), gestational age (27.6-27.8 weeks), birth weight and oxygen dependence. We did not observe any significant effect of treatment on survival, diagnosis and severity of BPD, duration of ventilatory support or oxygen therapy. For instance, the odds-ratio (95% confidence interval) for severe or moderate BPD were 1.04 (0.52-2.06) for inhaled beclomethasone and 1.54 (0.78-3.05) for inhaled salbutamol. Conclusion This randomised prospective trial does not support the use of treatment with inhaled beclomethasone, salbutamol or their combination in the prevention of BPD in premature ventilated neonates.

Language: English

Type (Professor's evaluation): Scientific

No. of pages: 6