drugset / Trial / NCT00767039

Curosurf and Survanta Treatment(CAST)of RDS in Very Premature Infants

NCT00767039

Phase 4 Terminated 52 enrolled Alan Fujii Dey · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

Approval of surfactant by the FDA in 1989 for the treatment of Respiratory Distress Syndrome (RDS) in premature infants greatly improved survival rates. Newer surfactants approved by the FDA were more concentrated and had a more rapid onset of action. The overall efficacy of newer surfactants appeared similar until in 2004, Ramanathan and colleagues suggested that a double dose of Curosurf improved survival in infants 25-32 weeks gestational age, compared to infants treated with Survanta, the most commonly used surfactant preparation in the United States. While the data was suggestive, it was not clear that the improvement in survival was reproducible or that Curosurf was responsible for the improved survival rates. The purpose of this study was to investigate the role of Curosurf in improving lung function and survival rates and reducing the complications of prematurity in very premature infants \< 30 weeks gestational age at birth.

Timeline

Start
2005-01
Primary completion
2008-09
Completion
2009-01

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Beractant Other / unclassified 100 mg/kg Other
Subject Poractant alfa Other / unclassified 100 mg/kg Other