Early CPAP in Respiratory Distress Syndrome | NCT00368680

Studies
Early CPAP in Respiratory Distress Syndrome

NCT00368680

Sponsor

Pontificia Universidad Catolica de Chile

Status

Unknown status

Last Update Posted

Dec 24, 2010Estimated

Enrollment

256Estimated

Phase

Phase 4

Conditions

Respiratory Distress Syndrome

Interventions

Early Bubble CPAP

Countries

Argentina
Chile
Paraguay
Peru
Uruguay

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

Apr 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Apr 2008

Completion Date

Sep 2009

First Submitted Date

Aug 24, 2006

First Submission Date that Met QC Criteria

Aug 24, 2006

First Posted Date

Aug 25, 2006Estimated

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

Dec 23, 2010

Last Update Posted Date

Dec 24, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Pontificia Universidad Catolica de ChileOTHER

Collaborators

Not provided

Description Module

Brief Summary

The purpose of this study is to establish if a strategy of EBCPAP application in a subgroup of VLBWI, 800 to 1500g birthweight, decreases the need for mechanical ventilation in this group, without affecting mortality.

Detailed Description

The application of CPAP has been described as an alternative respiratory support for premature newborns with respiratory distress.Many studies support that the early use of CPAP results in a better respiratory evolution and less need for mechanical ventilation.

Hypothesis:

- The hypothesis is that EBCPAP will decrease the need for this more invasive therapy.

The primary endpoint in this multicenter controlled study is to establish if an strategy of EBCPAP application in a subgroup of VLBWI, 800 to 1500g birthweight, decreases the need for mechanical ventilation in this group, without affecting mortality. .

As secondary outcome, the investigators will analyse: days of oxygen therapy, days of mechanical ventilation, need for surfactant , pulmonary airleak, intraventricular hemorrhage, persistent ductus arteriosus, retinopathy of prematurity and bronchopulmonary dysplasia (BPD) at 28 days and 36 weeks corrected gestational age.

Comparison(s):

Early Bubble CPAP (EBCPAP)with Standard Therapy which is oxygen.

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

256Estimated

Name	Type	Description	Arm Group Labels	Other Names
Early Bubble CPAP	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Need for mechanical ventilation

Secondary Outcomes

Measure	Description	Time Frame
Days of oxygen therapy
Days of mechanical ventilation
Need for surfactant

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All infants born at the units belonging to the South American Neocosur Network with a birthweight between 800 to 1500g and breathing spontaneously at birth or after hand bagging with Neopuff or transient intubation are eligible.
An informed consent form should be obtained preferable prenatal.

Exclusion Criteria:

Acute life threatening congenital malformations or genetics diseases.
Apgar score equal or less than 3 at 5 minutes
Disapproval of informed consent.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Minutes

Maximum Age

30 Minutes

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
José Luis Tapia, MD	Contact	56-2-3546437		jlta@med.puc.cl
Soledad Urzua, MD	Contact	56-2-3543348		soleurzua@gmail.com

Overall Officials

Name	Affiliation	Role
José Luis Tapia, MD	Pontificia Universidad Católica	Principal Investigator
Aldo Bancalari, MD	Hospital Guillermo Grant	Principal Investigator
Soledad Urzua, MD

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Servicio de Neonatología, Hospital de Clínicas José de San Martín	Recruiting	Buenos Aires			Argentina

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
4930602	Background	Gregory GA, Kitterman JA, Phibbs RH, Tooley WH, Hamilton WK. Treatment of the idiopathic respiratory-distress syndrome with continuous positive airway pressure. N Engl J Med. 1971 Jun 17;284(24):1333-40. doi: 10.1056/NEJM197106172842401. No abstract available.
1097619	Background	Krouskop RW, Brown EG, Sweet AY. The early use of continuous positive airway pressure in the treatment of idiopathic respiratory distress syndrome. J Pediatr. 1975 Aug;87(2):263-7. doi: 10.1016/s0022-3476(75)80599-3.

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders