Curosurf and Survanta Treatment(CAST)of RDS in Very Premature Infants
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
- Background Fujii AM, Editorial. Is There Really A Clinical Difference In Surfactant Preparations? J Perinatol 2010; 30:698; doi:10,1038/jp.2010.90
- Background Fujii A. Editorial. Are all animal derived surfactants the same? The e-NeoResearch 2011; 1 (1); 50-51.
- Results Fujii AM, Carillo M. Animal-derived surfactant treatment of respiratory distress syndrome in premature neonates: a review. Drugs Today (Barc). 2009 Sep;45(9):697-709. doi: 10.1358/dot.2009.45.9.1418185.
- Results Fujii AM, Patel SM, Allen R, Doros G, Guo CY, Testa S. Poractant alfa and beractant treatment of very premature infants with respiratory distress syndrome. J Perinatol. 2010 Oct;30(10):665-70. doi: 10.1038/jp.2010.20. Epub 2010 Mar 25.
- Results Fujii A, Allen R, Doros G, O'Brien S. Patent ductus arteriosus hemodynamics in very premature infants treated with poractant alfa or beractant for respiratory distress syndrome. J Perinatol. 2010 Oct;30(10):671-6. doi: 10.1038/jp.2010.21. Epub 2010 Mar 25.
- Results Fujii AM, Bailey J, Doros G, Sampat K, Sikes NC, Mason M, Kaiser JR. Cerebral Blood Flow Responses to Beractant and Poractant Administration. Journal of Neonatal-Perinatal Medicine 2009; 2:27-34
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Beractant | Other / unclassified | 100 mg/kg | Other |
| Subject | Poractant alfa | Other / unclassified | 100 mg/kg | Other |