Abstract
There is now convincing evidence that the severity of neonatal respiratory distress syndrome can be reduced by surfactant replacement therapy; however, the optimal therapeutic regimen has not been found. The aim of this randomized European Multicenter Trial “Single versus multiple doses” was to reduce the incidence of RDS-associated pulmonary complications as well as mortality in patients receiving multiple doses of surfactant. In this trial, preterm infants (birthweight 700-2000 g) with severe RDS requiring artificial ventilation with FiO2 ≥0.6 were randomized into two groups at an age of 2-15 h. Exclusion criteria have been recently published (Pediatrics 1988, 82, 683-691). Both groups received immediately after randomization the usual dose of Curosurf (200 mg/kg). In infants randomized to receive multiple treatment, two additional doses of Curosurf (100 mg/kg) were instilled into the airway at the age of 12 h and 24 h, provided that the patient still needed artificial ventilation with an FiO2 >0.21. Interim analysis (n=245) showed a reduction of pneumothorax incidence (17% vs. 8,3%); single vs. multiple doses; additionally, the incidence of BPD (17% vs. 10%) and mortality (23% vs. 14%) was reduced in multiple treated patients. Final data of approximately 300 patients included in this trial - which will be finished in april 1990 - will be presented.
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Speer, C., Curstedt, T., Robertson, B. et al. 28 RANDOMIZED EUROPEAN MULTICENTER TRIAL OF SURFACTANT REPLACEMENT IN NEONATAL RESPIRATORY DISTRESS SYNDROME (RDS): SINGLE VERSUS MULTIPLE DOSES OF CUROSURF. Pediatr Res 28, 281 (1990). https://doi.org/10.1203/00006450-199009000-00052
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DOI: https://doi.org/10.1203/00006450-199009000-00052