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 defined. This randomized European multicenter trial was designed to determine whether the beneficial effects of a single large dose of Curosurf (200 mg/kg) in babies with severe respiratory distress syndrome (arterial to alveolar oxygen tension ratio ∼0.10) could be enhanced by using multiple doses of surfactant. Preterm neonates (birth weight 700 to 2000 g) with severe respiratory distress syndrome requiring artificial ventilation with fraction of inspired oxygen ≥0.6 were randomized into two groups at an age of 2 to 15 hours. Both groups received the usual dose of Curosurf(200 mg/kg) immediately after randomization. In neonates randomized to receive multiple-dose treatment, two additional doses of Curosurf (100 mg/kg each) were instilled into the airways (12 and 24 hours after the initial dose) provided that the patients still needed artificial ventilation with fraction of inspired oxygen >0.21. In both groups (single dose: n = 176, multiple doses: n = 167) there was a rapid improvement in oxygenation as reflected by a threefold increase in arterial to alveolar oxygen tension ratio within 5 minutes after surfactant instillation (P < .001), and peak inspiratory pressure and mean airway pressure could be reduced significantly during the first 6 hours after surfactant treatment. In addition, ventilatory requirement (peak inspiratory pressure, ventilatory efficiency index) was reduced in the multiple-dose group 2 to 4 days after randomization (P < .05 to .01). Sixty-five percent of the patients randomized to the multiple-dose regimen and 68% of the single-dose group needed supplemental oxygen 12 hours after the first treatment. Analysis of 28-day outcome data showed a reduction of the incidence of pneumothorax in the multiple-dose group (9% vs 18%, P < .01). The primary end point, of combined incidence of mortality and bronchopulmonary dysplasia, was 33% in the single-dose group and 27% in the multiple-dose group (P = .08). Mortality at 28 days was reduced from 21% in the single-dose group to 13% in the multiple-dose group (P < .05 by logistic regression). It is concluded that treatment with multiple doses of surfactant is more effective than single-dose treatment in severe neonatal respiratory distress syndrome, further reducing pneumothorax mortality.
Randomized European Multicenter Trial of Surfactant Replacement Therapy for Severe Neonatal Respiratory Distress Syndrome: Single Versus Multiple Doses of Curosurf
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Christian P. Speer, Bengt Robertson, Tore Curstedt, Henry L. Halliday, Daniele Compagnone, Olaf Gefeller, Karsten Harms, Egbert Herting, Garth McClure, Marc Reid, Richard Tubman, Peter Herin, Gerd Noack, Joke Kok, Janna Koppe, Loekie van Sonderen, Edgar Laufkötter, Wolfgang Köhler, Herbert Boenisch, Klaus Albrecht, Ludwig Hanssler, Michaela Haim, Sidarto B. Oetomo, Albert Okken, Peter C. Altfeld, Peter Groneck, Walter Kachel, Jean-Pierre Relier, Herve Walti; Randomized European Multicenter Trial of Surfactant Replacement Therapy for Severe Neonatal Respiratory Distress Syndrome: Single Versus Multiple Doses of Curosurf. Pediatrics January 1992; 89 (1): 13–20. 10.1542/peds.89.1.13
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