Efficacy of Combining Prophylactic Curosurf With Early Nasal CPAP in Delivery Room: the Curpap Study
Study Identifier:
DM/PR/5000/002/04
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Study Contact Information:
N/A
Study Complete
Study Details
Medical Condition
- Neonatal Respiratory Distress Syndrome
Study Drug
- Drug: Poractant alfa (Curosurf®)
Date
Mar 2007 - May 2008
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 25 - 28 Weeks
Requirements Information
Healthy Volunteers
No
Protocol Summary
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.
Study Locations
Location
Status
Location
General Faculty Hospital
Prague, Czech Republic
Status
N/A
Location
Hopital De La Conception
Marseille, France
Status
N/A
Location
Ospedale Maggiore
Bologna, Italy
Status
N/A
Location
Maternidade Alfredo da Costa
Lisbon, Portugal
Status
N/A
Location
Hospital De Cruces
Bilbao, Spain
Status
N/A