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

• ClinicalTrials.gov Identifier: NCT00501982
• Recruitment Status: Completed
• First Posted: July 17, 2007
• Last Update Posted: August 3, 2020
• Sponsor: Chiesi Farmaceutici S.p.A.
• Information provided by (Responsible Party): Chiesi Farmaceutici S.p.A.

Tracking Information

• First Submitted Date: July 16, 2007
• First Posted Date: July 17, 2007
• Last Update Posted Date: August 3, 2020
• Study Start Date: March 2007
• Actual Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 16, 2007): Need for MV [ Time Frame: Within the first 5 days of life ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: March 18, 2015): Incidence of BPD and other complications of prematurity. Lenght of hospitalization. Clinical status until discharge home [ Time Frame: entire study ]
• Original Secondary Outcome Measures (submitted: July 16, 2007): Incidence of BPD and other complications of prematurity. Lenght of hospitalization. Clinical status until discharge home
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Respiratory Distress Syndrome, Newborn
• Intervention: Drug: Poractant alfa (Curosurf®)

Study Arms

• 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
  Intervention: Drug: Poractant alfa (Curosurf®)

• Publications *: 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. doi: 10.1542/peds.2009-2131. Epub 2010 May 3.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 3, 2008): 208
• Original Enrollment: Not Provided
• Actual Study Completion Date: May 2008
• Actual Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 25 Weeks to 28 Weeks (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Czechia, France, Italy, Portugal, Spain
• Removed Location Countries: Czech Republic

Administrative Information

• NCT Number: NCT00501982
• Other Study ID Numbers: DM/PR/5000/002/04
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Chiesi Farmaceutici S.p.A.
• Original Responsible Party: Not Provided
• Current Study Sponsor: Chiesi Farmaceutici S.p.A.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Laura Fabbri; Medical Department; Chiesi Farmaceutici S.p.A (Italy)

• PRS Account: Chiesi Farmaceutici S.p.A.
• Verification Date: July 2020