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

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ClinicalTrials.gov Identifier: NCT00501982
Recruitment Status : Completed
First Posted : July 17, 2007
Last Update Posted : April 13, 2018
Sponsor:
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

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 ]


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Ages Eligible for Study:   25 Weeks to 28 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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


Locations
Czechia
General Faculty Hospital
Prague, Czechia
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)

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT00501982     History of Changes
Other Study ID Numbers: DM/PR/5000/002/04
First Posted: July 17, 2007    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: April 2018

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

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