Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A. Identifier:
First received: July 16, 2007
Last updated: March 18, 2015
Last verified: March 2015

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of BPD and other complications of prematurity. Lenght of hospitalization. Clinical status until discharge home [ Time Frame: entire study ] [ Designated as safety issue: Yes ]

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
Experimental: 2
Poractant alfa (Curosurf) + N Cpap in delivery room
Drug: Poractant alfa (Curosurf®)


Ages Eligible for Study:   25 Weeks to 28 Weeks   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 identifier: NCT00501982

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Chiesi Farmaceutici S.p.A. Identifier: NCT00501982     History of Changes
Other Study ID Numbers: DM/PR/5000/002/04 
Study First Received: July 16, 2007
Last Updated: March 18, 2015
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.:
Mechanical Ventilation
Premature Infants
Neonatal Respiratory Distress Syndrome (nRDS)

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Poractant alfa
Pulmonary Surfactants
Respiratory System Agents processed this record on October 25, 2016