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
  Purpose

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.


Condition Intervention Phase
Respiratory Distress Syndrome, Newborn
Drug: Poractant alfa (Curosurf®)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Chiesi Farmaceutici S.p.A.:

Primary Outcome Measures:
  • Need for MV [ Time Frame: Within the first 5 days of life ]

Secondary Outcome Measures:
  • Incidence of BPD and other complications of prematurity. Lenght of hospitalization. Clinical status until discharge home

Enrollment: 208
Study Start Date: March 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
N Cpap in delivery room and than rescue curosurf in case of need
Drug: Poractant alfa (Curosurf®)
Experimental: 2
Poractant alfa (Curosurf) + N Cpap in delivery room
Drug: Poractant alfa (Curosurf®)

  Eligibility

Ages Eligible for Study:   25 Weeks to 28 Weeks
Genders Eligible for Study:   Both
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00501982

Locations
Czech Republic
General Faculty Hospital
Prague, Czech Republic
France
Hopital De La Conception
Marseille, France
Italy
Ospedale Maggiore
Bologna, Italy
Portugal
Maternidade Alfredo da Costa
Lisbon, Portugal
Spain
Hospital De Cruces
Bilbao, Spain
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Investigators
Study Director: Laura Fabbri Medical Department; Chiesi Farmaceutici S.p.A (Italy)
  More Information

No publications provided by Chiesi Farmaceutici S.p.A.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00501982     History of Changes
Other Study ID Numbers: DM/PR/5000/002/04
Study First Received: July 16, 2007
Last Updated: November 3, 2008
Health Authority: France: Ministry of Health
Czech Republic: State Institute for Drug Control
Italy: Ethics Committee
Spain: Ethics Committee
Spain: Ministry of Health
Brazil: National Committee of Ethics in Research
Brazil: Ministry of Health

Keywords provided by Chiesi Farmaceutici S.p.A.:
surfactant
RDS
nCPAP
Mechanical Ventilation
Premature Infants
Neonatal Respiratory Distress Syndrome (nRDS)

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Syndrome
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Disease
Pathologic Processes
Poractant alfa
Pulmonary Surfactants
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014