CLINICAL TRIALS PROFILE FOR PORACTANT ALFA
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All Clinical Trials for Poractant Alfa
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00767039 ↗ | Curosurf and Survanta Treatment(CAST)of RDS in Very Premature Infants | Terminated | Dey LP | Phase 4 | 2005-01-01 | 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. |
| NCT00767039 ↗ | Curosurf and Survanta Treatment(CAST)of RDS in Very Premature Infants | Terminated | Alan Fujii | Phase 4 | 2005-01-01 | 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. |
| NCT01941524 ↗ | Brain Oxygenation and Function of Preterm Newborns During Administration of Two Different Surfactant Preparations | Completed | Poznan University of Medical Sciences | Phase 4 | 2013-03-03 | The purpose of the study is to determine whether there are differences in bioelectrical function (measured by amplitude integrated electroencephalography) and brain oxygenation (measured by near infrared spectroscopy) while and after instillation of two different surfactant preparations. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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