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

被引:55
作者
Denjean, A
Paris-Llado, J
Zupan, V
Debillon, T
Kieffer, F
Magny, JF
Desfrères, L
Llanas, B
Guimaraes, H
Moriette, G
Voyer, M
Dehan, M
Breart, G
机构
[1] Hop Antoine Beclere, Serv Explorat Fonct & Reanimat Neonatale, F-92141 Clamart, France
[2] CHU Cochin Port Royal, INSERM U149, Unite Rech Epidemiol Sante Femmes & Enfants, F-75679 Paris, France
[3] CHU Nantes, Hosp Mere Enfants, F-44035 Nantes, France
[4] Hop Pellegrin, F-33076 Bordeaux, France
[5] Hosp S Joao, Serv Neonatol, P-4200 Oporto, Portugal
[6] Inst Puericulture, F-75014 Paris, France
关键词
premature infants; respiratory distress; bronchopulmonary dysplasia; salbutamol; beclomethasone;
D O I
10.1007/s004310050969
中图分类号
R72 [儿科学];
学科分类号
100202 ;
摘要
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.
引用
收藏
页码:926 / 931
页数:6
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