drugset / Trial / NCT00005774

Early Surfactant to Reduce Use of Mechanical Breathing in Low Birth Weight Infants

NCT00005774

RandomizedSingle-groupOpen-labelTreatment

Summary

Mechanical ventilation (MV) of preterm infants with respiratory distress syndrome (RDS) is associated with lung injury and nosocomial infection. Moderately premature infants with mild respiratory distress do not routinely receive artificial surfactant early in their course of treatment. This multi-center, randomized trial tested whether early surfactant therapy and nasal continuous positive airway pressure (CPAP) in infants 1,250-2,000g with RDS reduced mechanical ventilation usage without added complications. Infants with mild to moderate respiratory distress syndrome were enrolled in the trial and given either early administration of surfactant followed by extubation within 30 minutes and the use of CPAP, or standard practice (surfactant according to current center practice, only after initiation of mechanical ventilation), to see whether the experimental method would reduce the need for subsequent mechanical ventilation.

Timeline

Start
2000-05
Primary completion
2002-07
Completion
2002-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Beractant Other / unclassified