PEDIATRICS Vol. 100 No. 1 July 1997, p. e4
Copyright ©1997 by the American Academy of Pediatrics

ELECTRONIC ARTICLE:
Mortality, Severe Respiratory Distress Syndrome, and Chronic Lung Disease of the Newborn Are Reduced More After Prophylactic Than After Therapeutic Administration of the Surfactant Curosurf

Received Jun 26, 1996; accepted Nov 17, 1996.

Johannes Egberts^*, Roland Brand, Hervé Walti^§, Giulio Bevilacqua, Gérard Bréart MD^¶, and Fabrizio Gardini^#

From the Departments of ^* Obstetrics and Gynecology and  Medical Statistics, University of Leiden, The Netherlands; ^§ Service de Médicine Néonatale, CHU Cochin Port Royal, Paris and ^¶ Unité de Recherche Épidémiologique sur la Santé des Femmes et des Enfants INSERM U-149, Paris, France; and the  Institute of Child Health and Neonatal Medicine, University of Parma and ^# Division of Statistics, Chiesi Farmaceutici SPA, Parma, Italy.

Objective.  To test the hypothesis that prophylactic treatment with the surfactant Curosurf (Chiesi Farmaceutici SPA, Parma, Italy) improves survival and respiratory problems more than rescue treatment.

Design.  Meta-analysis of three prophylaxis versus rescue treatment trials, conducted in four countries.

Methods.  A meta-analysis was performed with the original, individual data of mortality, severe respiratory distress syndrome, and chronic lung disease of 671 newborns as outcomes. The random-effects logistic model (accounting for the trial-within-country structure) was applied and adjusted for imbalances in covariates.

Results.  The probability of each outcome differed between the countries, but the actual treatment effect itself did not. The adjusted odds ratios (ORs) and confidence intervals (CIs) for prophylaxis versus rescue were as follows: mortality: OR, .47; 95% CI, .30 to .73; severe RDS: OR, .50; 95% CI, .33 to .74; and chronic lung disease of the newborn in the survivors at day 28 after birth: OR, .54; 95% CI, .34 to .86. Gender, birth weight, gestational age, and prenatal administration of glucocorticosteroids were significant confounding covariates.

Conclusion.  The analysis shows that for the porcine surfactant Curosurf, prophylactic administration of surfactant has significant advantages over rescue therapy.

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