Clinical Trial: Efficacy of Combining Prophylactic Curosurf With Early Nasal CPAP in Delivery Room: the Curpap Study
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An International, Open, Randomized, Controlled Study to Evaluate the Efficacy of Combining Prophylactic Curosurf® With Early Nasal CPAP Versus Early Nasal CPAP Alone in Very Preterm Infants at Ri
Brief 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:
- Early stabilization on nCPAP
- 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.
Detailed Summary:
Sponsor: Chiesi Farmaceutici S.p.A.
Current Primary Outcome: Need for MV [ Time Frame: Within the first 5 days of life ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Incidence of BPD and other complications of prematurity. Lenght of hospitalization. Clinical status until discharge home [ Time Frame: entire study ]
Original Secondary Outcome: Incidence of BPD and other complications of prematurity. Lenght of hospitalization. Clinical status until discharge home
Information By: Chiesi Farmaceutici S.p.A.
Dates:
Date Received: July 16, 2007
Date Started: March 2007
Date Completion:
Last Updated: March 18, 2015
Last Verified: March 2015
