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Generated: December 14, 2018

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CLINICAL TRIALS PROFILE FOR CUROSURF

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Clinical Trials for Curosurf

Trial ID Title Status Sponsor Phase Summary
NCT00501982 Efficacy of Combining Prophylactic Curosurf With Early Nasal CPAP in Delivery Room: the Curpap Study Completed Chiesi Farmaceutici S.p.A. Phase 4 The primary objective of this study is to compare two methods of post-delivery stabilization and subsequent early respiratory care for reducing the need for MV and related secondary complications, such as BPD, in premature babies at high risk of RDS: 1. Early stabilization on nCPAP 2. Intubation, prophylactic surfactant (Curosurf®) administration shortly after delivery, and rapid extubation to nCPAP. The data obtained from this comparison will be applied to test the hypothesis that preterm neonates at risk of RDS who are treated with prophylactic surfactant + nCPAP show less need for MV when compared to infants who receive nCPAP alone.
NCT00767039 Curosurf and Survanta Treatment(CAST)of RDS in Very Premature Infants Terminated Dey LP Phase 4 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 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.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Curosurf

Condition Name

Condition Name for Curosurf
Intervention Trials
Respiratory Distress Syndrome 9
Respiratory Distress Syndrome, Newborn 3
Bronchopulmonary Dysplasia 2
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Condition MeSH

Condition MeSH for Curosurf
Intervention Trials
Respiratory Distress Syndrome, Newborn 13
Respiratory Distress Syndrome, Adult 13
Syndrome 10
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Clinical Trial Locations for Curosurf

Trials by Country

Trials by Country for Curosurf
Location Trials
Italy 9
United States 5
Portugal 1
Canada 1
Mexico 1
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Trials by US State

Trials by US State for Curosurf
Location Trials
Missouri 1
Oklahoma 1
Georgia 1
Michigan 1
Massachusetts 1
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Clinical Trial Progress for Curosurf

Clinical Trial Phase

Clinical Trial Phase for Curosurf
Clinical Trial Phase Trials
Phase 4 4
Phase 3 2
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Curosurf
Clinical Trial Phase Trials
Completed 5
Recruiting 4
Not yet recruiting 3
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Clinical Trial Sponsors for Curosurf

Sponsor Name

Sponsor Name for Curosurf
Sponsor Trials
Chiesi Farmaceutici S.p.A. 4
nihat demir 1
Ottawa Hospital Research Institute 1
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Sponsor Type

Sponsor Type for Curosurf
Sponsor Trials
Other 27
Industry 7
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