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

Primary Purpose

Respiratory Distress Syndrome, Newborn

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Poractant alfa (Curosurf®)
Sponsored by
Chiesi Farmaceutici S.p.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Respiratory Distress Syndrome, Newborn focused on measuring surfactant, RDS, nCPAP, Mechanical Ventilation, Premature Infants, Neonatal Respiratory Distress Syndrome (nRDS)

Eligibility Criteria

25 Weeks - 28 Weeks (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • General Faculty Hospital
  • Hopital De La Conception
  • Ospedale Maggiore
  • Maternidade Alfredo da Costa
  • Hospital De Cruces

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

1

2

Arm Description

N Cpap in delivery room and than rescue curosurf in case of need

Poractant alfa (Curosurf) + N Cpap in delivery room

Outcomes

Primary Outcome Measures

Need for MV

Secondary Outcome Measures

Incidence of BPD and other complications of prematurity. Lenght of hospitalization. Clinical status until discharge home

Full Information

First Posted
July 16, 2007
Last Updated
July 30, 2020
Sponsor
Chiesi Farmaceutici S.p.A.
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1. Study Identification

Unique Protocol Identification Number
NCT00501982
Brief Title
Efficacy of Combining Prophylactic Curosurf With Early Nasal CPAP in Delivery Room: the Curpap Study
Acronym
Curpap
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 Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chiesi Farmaceutici S.p.A.

4. Oversight

5. Study Description

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: Early stabilization on nCPAP 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome, Newborn
Keywords
surfactant, RDS, nCPAP, Mechanical Ventilation, Premature Infants, Neonatal Respiratory Distress Syndrome (nRDS)

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
208 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
N Cpap in delivery room and than rescue curosurf in case of need
Arm Title
2
Arm Type
Experimental
Arm Description
Poractant alfa (Curosurf) + N Cpap in delivery room
Intervention Type
Drug
Intervention Name(s)
Poractant alfa (Curosurf®)
Primary Outcome Measure Information:
Title
Need for MV
Time Frame
Within the first 5 days of life
Secondary Outcome Measure Information:
Title
Incidence of BPD and other complications of prematurity. Lenght of hospitalization. Clinical status until discharge home
Time Frame
entire study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Weeks
Maximum Age & Unit of Time
28 Weeks
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Fabbri
Organizational Affiliation
Medical Department; Chiesi Farmaceutici S.p.A (Italy)
Official's Role
Study Director
Facility Information:
Facility Name
General Faculty Hospital
City
Prague
Country
Czechia
Facility Name
Hopital De La Conception
City
Marseille
Country
France
Facility Name
Ospedale Maggiore
City
Bologna
Country
Italy
Facility Name
Maternidade Alfredo da Costa
City
Lisbon
Country
Portugal
Facility Name
Hospital De Cruces
City
Bilbao
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
20439601
Citation
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.
Results Reference
result
Links:
URL
https://www.clinicaltrialsregister.eu/ctr-search/search?query=2006-004105-25
Description
Study Record on EU Clinical Trials Register including results

Learn more about this trial

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

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