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European Journal of Pediatrics

, Volume 157, Issue 11, pp 926–931 | Cite as

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

  • A. Denjean
  • J. Paris-Llado
  • V. Zupan
  • T. Debillon
  • F. Kieffer
  • J.-F. Magny
  • L. Desfrères
  • B. Llanas
  • H. Guimaraes
  • G. Moriette
  • M. Voyer
  • M. Dehan
  • G. Breart
NEONATOLOGY

Abstract

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.

Key words Premature infants Respiratory distress Bronchopulmonary dysplasia Salbutamol Beclomethasone 

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Copyright information

© Springer-Verlag Berlin Heidelberg 1998

Authors and Affiliations

  • A. Denjean
    • 1
  • J. Paris-Llado
    • 2
  • V. Zupan
    • 1
  • T. Debillon
    • 3
  • F. Kieffer
    • 4
  • J.-F. Magny
    • 4
  • L. Desfrères
    • 5
  • B. Llanas
    • 6
  • H. Guimaraes
    • 7
  • G. Moriette
    • 5
  • M. Voyer
    • 4
  • M. Dehan
    • 1
  • G. Breart
    • 2
  1. 1.Services d'Explorations Fonctionnelles et Réanimation Néonatale, Hôpital Antoine Béclère, F-92141 Clamart, FranceFR
  2. 2.INSERM U149 Unité de Recherche épidémiologique sur la santé des femmes et des enfants, CHU Cochin Port Royal, F-75679 Paris, FranceFR
  3. 3.Réanimation néonatale, Hôpital Mère-Enfants, CHU de Nantes, F-44035 Nantes, FranceFR
  4. 4.Institut de Puériculture, F-75014 Paris, FranceFR
  5. 5.CHU Cochin Port Royal, F-75679 Paris, FranceFR
  6. 6.Hôpital Pellegrin-Enfants, F-33076 Bordeaux, FranceFR
  7. 7.Servicio de Neonatologia, Hospital S. Joao, P-4200 Porto, PortugalPT

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