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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Respiratory Distress Syndrome, Newborn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

N Cpap in delivery room and than rescue curosurf in case of need

Group Type NO_INTERVENTION

No interventions assigned to this group

2

Poractant alfa (Curosurf) + N Cpap in delivery room

Group Type EXPERIMENTAL

Poractant alfa (Curosurf®)

Intervention Type DRUG

Interventions

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Poractant alfa (Curosurf®)

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

25 Weeks

Maximum Eligible Age

28 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No