Efficacy of Combining Prophylactic Curosurf With Early Na... | NCT00501982

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

NCT00501982

Sponsor

Chiesi Farmaceutici S.p.A.

Status

Completed

Last Update Posted

Aug 3, 2020Actual

Enrollment

208Actual

Phase

Phase 4

Conditions

Respiratory Distress Syndrome, Newborn

Interventions

Poractant alfa (Curosurf®)

Countries

Czechia
France
Italy
Portugal
Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

May 2008Actual

Completion Date

May 2008Actual

First Submitted Date

Jul 16, 2007

First Submission Date that Met QC Criteria

Jul 16, 2007

First Posted Date

Jul 17, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 30, 2020

Last Update Posted Date

Aug 3, 2020Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

208Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Poractant alfa (Curosurf®)	Drug		2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Need for MV		Within the first 5 days of life

Secondary Outcomes

Measure	Description	Time Frame
Incidence of BPD and other complications of prematurity. Lenght of hospitalization. Clinical status until discharge home		entire study

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Weeks

Maximum Age

28 Weeks

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Laura Fabbri	Medical Department; Chiesi Farmaceutici S.p.A (Italy)	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
General Faculty Hospital		Prague			Czechia
Hopital De La Conception

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20439601	Result	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.

ID	Term
D012127	Respiratory Distress Syndrome, Newborn
D047928	Premature Birth

ID	Term
D012128	Respiratory Distress Syndrome
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders