NCT00501982

Efficacy of Combining Prophylactic Curosurf With Early Nasal CPAP in Delivery Room: the Curpap Study

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 Risk of Respiratory Distress Syndrome

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 208 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 25 Weeks – 28 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Respiratory Distress Syndrome, Newborn

Interventions

Type	Name	Description
DRUG	Poractant alfa (Curosurf®)

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2007-07-17
• Last updated: 2020-08-03

Locations

5 sites across 5 countries: Czechia, France, Italy, Portugal, Spain