Inhaled salbutamol and beclomethasone for preventing broncho-pulmonary dysplasia : a randomised double-blind study.
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. (...)
Mots-clés Pascal : Dysplasie bronchopulmonaire, Prématuré, Détresse respiratoire, Ventilation assistée, France, Europe, Prévention, Etude double insu, Etude statistique, Randomisation, Béclométasone, Antiinflammatoire, Inhalation, Salbutamol, Bronchodilatateur, Agoniste, Nouveau né, Homme, Appareil respiratoire pathologie, Poumon pathologie, Bronche pathologie, Nouveau né pathologie, Réanimation respiratoire, Unité soin intensif, Corticostéroïde, Chimioprophylaxie
Mots-clés Pascal anglais : Bronchopulmonary dysplasia, Premature, Respiratory distress, Assisted ventilation, France, Europe, Prevention, Double blind study, Statistical study, Randomization, Beclometasone, Antiinflammatory agent, Inhalation, Salbutamol, Bronchodilator, Agonist, Newborn, Human, Respiratory disease, Lung disease, Bronchus disease, Newborn diseases, Respiratory intensive care, Intensive care unit, Corticosteroid, Chemoprophylaxis
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 99-0025762
Code Inist : 002B27B02. Création : 31/05/1999.