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

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chiesi Farmaceutici S.p.A.
• Treatments: Poractant alfa

Criteria

Inclusion Criteria:

• Preterm neonates with a gestational age (GA) of 25+0 - 28+6 completed weeks.

• Inborn neonates.

• In case of twins, both neonates will be included in the same treatment arm.

• Parental written informed consent for participation in the study obtained on admission into the hospital or prior to delivery.

Exclusion Criteria:

• Evidence of severe birth asphyxia, that is an APGAR score below 3 at 5 minutes of age.

• Need for endotracheal intubation for cardiopulmonary resuscitation or insufficient respiratory drive.

• Known genetic or chromosomal disorders.

• Delivered to mothers with ruptured membranes of more than 3 weeks duration.

• Potentially life-threatening conditions unrelated to immaturity.

• Participation in another clinical trial of any placebo, drug, biological, or device conducted under the provisions of a protocol.