We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00501982
Recruitment Status : Completed
First Posted : July 17, 2007
Last Update Posted : August 3, 2020
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.

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.

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Arm Intervention/treatment
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®)

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

Secondary Outcome Measures :
  1. Incidence of BPD and other complications of prematurity. Lenght of hospitalization. Clinical status until discharge home [ Time Frame: entire study ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   25 Weeks to 28 Weeks   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00501982

Layout table for location information
General Faculty Hospital
Prague, Czechia
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.
Layout table for investigator information
Study Director: Laura Fabbri Medical Department; Chiesi Farmaceutici S.p.A (Italy)
Additional Information:
Publications of Results:
Layout table for additonal information
Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT00501982    
Other Study ID Numbers: DM/PR/5000/002/04
First Posted: July 17, 2007    Key Record Dates
Last Update Posted: August 3, 2020
Last Verified: July 2020
Keywords provided by Chiesi Farmaceutici S.p.A.:
Mechanical Ventilation
Premature Infants
Neonatal Respiratory Distress Syndrome (nRDS)
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Poractant alfa
Pulmonary Surfactants
Respiratory System Agents