Abstract

In an international multicenter trial infants with clinical and radiological signs of severe RDS were randomized to receive either a single dose (n=176) or three subsequent doses (n=167) of a porcine natural surfactant (Curosurf). Using a logistic regression model the effects of therapy, birth weight, sex, and other clinical factors on survival and various outcome parameters were evaluated. Results: Mortality (13vs.21%, p<0.05) and the incidence of pneumothoraces (9vs. 18%, p<0.01) were significantly lower in the multiple-dose group. Low birth weight, hospital allocation, low Apgar and initial disease severity were associated with an increased mortality. Low birth weight, hypothermia (admission temperature <36°C) and acidosis (pH<7.25) prior to surfactant treatment could be identified as risk factors for the development of an intracranial hemorrhage. Conclusion: Mortality and the incidence of pneumothoraces were significantly reduced after multiple-dose treatment of severe RDS as compared to a single dose regimen. 28 day outcome in surfactant treated infants is influenced by various clinical factors.

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