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

NCT00501982 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2020-08-03

No results posted yet for this study

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.

Conditions

  • Respiratory Distress Syndrome, Newborn

Interventions

DRUG

Poractant alfa (Curosurf®)

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Laura Fabbri · Medical Department; Chiesi Farmaceutici S.p.A (Italy)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Weeks
Max Age
28 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2008-05-31
Completion
2008-05-31

Countries

  • Czechia
  • France
  • Italy
  • Portugal
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00501982 on ClinicalTrials.gov