Cpap at Delivery Room for Preterm Infants | NCT01024361

Studies
Cpap at Delivery Room for Preterm Infants

NCT01024361

Sponsor

University of Sao Paulo

Status

Unknown status

Last Update Posted

Dec 23, 2009Estimated

Enrollment

200Estimated

Phase

Phase 4

Conditions

Mechanical Ventilation
Retinal Disease
Death
Respiratory Tract Disease

Interventions

CPAP

Countries

Not provided

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
FAPESP 06/61388-2	Other Grant/Funding Number	FAPESP 06/61388-2

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Dec 2009Estimated

Completion Date

Dec 2010Estimated

First Submitted Date

Nov 27, 2009

First Submission Date that Met QC Criteria

Dec 1, 2009

First Posted Date

Dec 2, 2009Estimated

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 21, 2009

Last Update Posted Date

Dec 23, 2009Estimated

Name	Class
Fundação de Amparo à Pesquisa do Estado de São Paulo	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of the study is to determine if CPAP applied within less than 15 min of life in the DR reduces the necessity of mechanical ventilation and surfactant during the first 5 days of life.

Detailed Description

A multicenter prospective cohort of inborn preterm infants, born at 8 public university NICU in Brazil, with birthweight 1000-1499 g, without malformations, not intubated at 15 minutes of life. Preterm infants will be randomly assigned at birth to an early treatment group (DR-CPAP), in which CPAP of 5 cm water pressure is applied within 15 minutes after birth by Neopuff, or to a routine group (RG), in which CPAP is applied when indicated by the assistant physician. After transfer to the NICU, nasal CPAP will be maintained with Hudson prongs

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

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Routine	No Intervention	Routine protocol of the service
CPAP-DR	Experimental	Infants randomized to this arm will have nasal CPAP installation at delivery room before the 15th minute of life	Device: CPAP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CPAP	Device	CPAP of 5 cm water pressure will be applied within 15 minutes after birth by Neopuff	CPAP-DR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Necessity of mechanical ventilation and surfactant during the first 5 days of life		5 days

Secondary Outcomes

Measure	Description	Time Frame
Maternal and infant characteristics associated with CPAP failure during the first 15 minutes of life		15 minutes
Incidence of pneumothorax, interstitial emphysema, ductus arteriosus, peri- intra-ventricular hemorrhage, sepsis, necrotizing enterocolitis

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:Inborn.

Birth weight 1000g to 1500g
No major malformations

Exclusion Criteria:

Necessity of intubation
Maternal decision

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Minute

Maximum Age

15 Minutes

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Francisco E Martinez, MD	University of sao Paulo at Ribeirão Preto	Principal Investigator

Locations

Not provided

Type	Date	Date Unknown
Release	Jan 23, 2012
Reset	Feb 23, 2012
Release	Dec 2, 2014
Reset	Dec 2, 2014

Submission Tracking

Estimated Results First Submitted Date

Jan 23, 2012

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jan 23, 2012			Feb 23, 2012
Dec 2, 2014

Condition Browse Module

MeSH Terms

ID	Term
D012164	Retinal Diseases
D003643	Death
D012140	Respiratory Tract Diseases

Ancestor Terms

ID	Term
D005128	Eye Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

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