Curosurf and Survanta Treatment(CAST)of RDS in Very Premature Infants
Stopped early · Phase 4
Conditions studied: Prematurity, Respiratory Distress Syndrome, Patent Ductus Arteriosus
In brief
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.
Key facts
- Study ID
- NCT00767039
- Run by
- Alan Fujii
- People needed
- 52
- Starts
- 2005-01-01
- Expected to finish
- 2009-01-01
- Last updated by the study team
- 2011-10-03
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- <29 6/7 and >24 0/7 weeks gestational age
- Inborn at the participating institution enrolling the patient
- FIO2 >25% and Intubated with mean airway pressure > 5 cm H20
- <8 hours age at randomization
- Signed informed consent from parent(s)
You may not qualify if…
- <500 g birth weight
- <24 0/7 weeks gestational age (best estimate)
- Prolonged Premature Rupture of membranes >3 weeks (21 days)
- Apgar score < 3 at 5 minutes
- Impending death anticipated within the first 3 days of life, moribund
- Severe congenital anomalies
Where it is running
- Boston Medical Center — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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