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

Chiesi

Status and phase

Completed

Phase 4

Conditions

Respiratory Distress Syndrome, Newborn

Treatments

Drug: Poractant alfa (Curosurf®)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00501982

DM/PR/5000/002/04

Details and patient eligibility

About

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.

Enrollment

208 patients

Sex

All

Ages

25 to 28 weeks old

Volunteers

No Healthy Volunteers

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.