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

Sponsored by:	Chiesi Farmaceutici S.p.A.
Information provided by:	Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:	NCT00501982

Purpose

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.

Condition	Intervention	Phase
Respiratory Distress Syndrome, Newborn	Drug: Poractant alfa (Curosurf®)	Phase IV

MedlinePlus related topics: Premature Babies

Drug Information available for: Curosurf

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy 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

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 ]

Secondary Outcome Measures:

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

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
1: No Intervention N Cpap in delivery room and than rescue curosurf in case of need	Drug: Poractant alfa (Curosurf®)
2: Experimental Poractant alfa (Curosurf) + N Cpap in delivery room	Drug: Poractant alfa (Curosurf®)

Eligibility

Ages Eligible for Study:	25 Weeks to 28 Weeks
Genders Eligible for Study:	Both

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00501982

Locations

Czech Republic
General Faculty Hospital
Prague, Czech Republic
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)

More Information

Study ID Numbers:	DM/PR/5000/002/04
Study First Received:	July 16, 2007
Last Updated:	November 3, 2008
ClinicalTrials.gov Identifier:	NCT00501982
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.:

surfactant
RDS
nCPAP

Mechanical Ventilation
Premature Infants
Neonatal Respiratory Distress Syndrome (nRDS)

Study placed in the following topic categories:

Respiratory distress syndrome, infant
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Respiratory Distress Syndrome, Adult
Poractant alfa

Respiratory Distress Syndrome, Newborn
Infant, Newborn, Diseases
Acute respiratory distress syndrome
Infant, Premature, Diseases
Hyaline Membrane Disease

Additional relevant MeSH terms:

Respiratory System Agents
Pathologic Processes
Disease
Therapeutic Uses

Syndrome
Pharmacologic Actions
Pulmonary Surfactants

ClinicalTrials.gov processed this record on January 14, 2009