Early NCPAP Before Surfactant Treatment in Very Preterm I... | NCT01996670

Studies
Early NCPAP Before Surfactant Treatment in Very Preterm Infants With RDS

NCT01996670

Sponsor

Xiangya Hospital of Central South University

Status

Completed

Last Update Posted

Nov 27, 2013Estimated

Enrollment

683Actual

Phase

Not provided

Conditions

Nasal Continuous Positive Airway Pressure,
Preterm Infants,
Surfactant Treatment,
Respiratory Distress Syndrome,
Bronchopulmonary Dysplasia

Interventions

Not provided

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

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

ID	Type	Description	Link
huo20131121	Registry Identifier	huohuoyi

Status Module

Record Verification Date

Jan 2007

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

Jan 2007

Primary Completion Date

Dec 2012Actual

Completion Date

Not provided

First Submitted Date

Nov 21, 2013

First Submission Date that Met QC Criteria

Nov 21, 2013

First Posted Date

Nov 27, 2013Estimated

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

Nov 21, 2013

Last Update Posted Date

Nov 27, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Huiyi Huo, Department of Neonatology, Xiangya Hospital of Central South UniversityPrincipal Investigator

Lead Sponsor

Xiangya Hospital of Central South UniversityOTHER

Collaborators

Not provided

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

We hypothesis a period of early NCPAP before surfactant treatment is effective for treating RDS and preventing BPD in very premature infants.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

683Actual

Measure	Description	Time Frame
death or bronchopulmonary dysplasia		24 hours after birth

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All enrolled infants were able to breathe at 5 min of age, had evidence of respiratory distress, unable to receive surfactant therapy, and were administrated with early NCPAP as the initial treatment

Exclusion Criteria:

Exclusion criteria were endotracheal intubation for resuscitation or insufficient respiratory drive, died in the first 24 hours after birth, known genetic disorders, potentially life-threatening conditions unrelated to prematurity, and premature rupture of membranes (PROM) for >3 weeks.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Minutes

Maximum Age

2 Hours

Standard Ages

Child

Study Population

inborn infants at 26-32 weeks gestation with RDS, whom received NCPAP as the initial treatment, followed by surfactant treatment within 24 h after birth

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D012128	Respiratory Distress Syndrome
D001997	Bronchopulmonary Dysplasia

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders
D055397	Ventilator-Induced Lung Injury

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
<2h group
2-4h group
>4h group