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

Study Overview
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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: 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.

Official Title
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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

Conditions
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Respiratory Distress Syndrome, Newborn

Intervention / Treatment
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* Drug: Poractant alfa (Curosurf®)


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Weeks
Maximum Age: 28 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>N Cpap in delivery room and than rescue curosurf in case of need | |
| Experimental: 2<br>Poractant alfa (Curosurf) + N Cpap in delivery room | Drug: Poractant alfa (Curosurf®)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for MV |  | Within the first 5 days of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of BPD and other complications of prematurity. Lenght of hospitalization. Clinical status until discharge home |  | entire study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surfactant, RDS, nCPAP, Mechanical Ventilation, Premature Infants, Neonatal Respiratory Distress Syndrome (nRDS)