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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00501982

Acronym

Curpap

Enrollment

208

Registered

2007-07-17

Start date

2007-03-31

Completion date

2008-05-31

Last updated

2020-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Syndrome, Newborn

Keywords

surfactant, RDS, nCPAP, Mechanical Ventilation, Premature Infants, Neonatal Respiratory Distress Syndrome (nRDS)

Brief 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.

Interventions

DRUGPoractant alfa (Curosurf®)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

25 Weeks to 28 Weeks

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.

Design outcomes

Primary

Measure	Time frame
Need for MV	Within the first 5 days of life

Secondary

Measure	Time frame
Incidence of BPD and other complications of prematurity. Lenght of hospitalization. Clinical status until discharge home	entire study

Countries

Czechia, France, Italy, Portugal, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026