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

This study has been completed.
Sponsor:
Information provided by:
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT00501982
First received: July 16, 2007
Last updated: November 3, 2008
Last verified: November 2008
History of Changes

July 16, 2007
November 3, 2008
March 2007
May 2008   (final data collection date for primary outcome measure)
Need for MV [ Time Frame: Within the first 5 days of life ]
Same as current
Complete list of historical versions of study NCT00501982 on ClinicalTrials.gov Archive Site
Incidence of BPD and other complications of prematurity. Lenght of hospitalization. Clinical status until discharge home
Same as current
Not Provided
Not Provided
 
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

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Respiratory Distress Syndrome, Newborn
Drug: Poractant alfa (Curosurf®)
  • No Intervention: 1
    N Cpap in delivery room and than rescue curosurf in case of need
    Intervention: Drug: Poractant alfa (Curosurf®)
  • Experimental: 2
    Poractant alfa (Curosurf) + N Cpap in delivery room
    Intervention: Drug: Poractant alfa (Curosurf®)
Sandri F, Plavka R, Ancora G, Simeoni U, Stranak Z, Martinelli S, Mosca F, Nona J, Thomson M, Verder H, Fabbri L, Halliday H; CURPAP Study Group. Prophylactic or early selective surfactant combined with nCPAP in very preterm infants. Pediatrics. 2010 Jun;125(6):e1402-9. Epub 2010 May 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
208
May 2008
May 2008   (final data collection date for primary outcome measure)

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.
Both
25 Weeks to 28 Weeks
Not Provided
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   France,   Italy,   Portugal,   Spain
 
NCT00501982
DM/PR/5000/002/04
Not Provided
Not Provided
Chiesi Farmaceutici S.p.A.
Not Provided
Study Director: Laura Fabbri Medical Department; Chiesi Farmaceutici S.p.A (Italy)
Chiesi Farmaceutici S.p.A.
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP