Nasal Intermittent Positive-Pressure Ventilation for Twin... | NCT01926106

Studies
Nasal Intermittent Positive-Pressure Ventilation for Twin Infants With Respiratory Distress Syndrome

NCT01926106

Sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Status

Completed

Last Update Posted

Dec 7, 2017Actual

Enrollment

286Actual

Phase

Not Applicable

Conditions

Neonatal Respiratory Distress Syndrome

Interventions

nIPPV
nCPAP

Countries

China

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

Aug 2013

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

Jul 1, 2012Actual

Primary Completion Date

Jul 30, 2017Actual

Completion Date

Jul 30, 2017Actual

First Submitted Date

Aug 8, 2013

First Submission Date that Met QC Criteria

Aug 19, 2013

First Posted Date

Aug 20, 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

Dec 6, 2017

Last Update Posted Date

Dec 7, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chen Long,MD, Prof;MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityPrincipal Investigator

Lead Sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical 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

In the present study, we hypothesized that primary mode nIPPV initiated shortly after birth would decrease the incidence of intubation or death in twin infants when compared to nCPAP.

Detailed Description

After inclusion of eligible twins infants,one of the twins was supported by nCPAP and another nIPPV.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

286Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
nIPPV	Experimental	the infants in the arm were supported by Nasal Intermittent Positive-Pressure Ventilation(nIPPV)	Device: nIPPV
nCPAP	Active Comparator	the infants in the arm were supported by Nasal Continuous Positive Airway Pressure(nCPAP)	Device: nCPAP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
nIPPV	Device	one of the twins was randomly allocated to nIPPV	nIPPV

Measure	Description	Time Frame
incidence of intubation		48h

Measure	Description	Time Frame
incidence of BPD		1 month

Measure	Description	Time Frame
death		3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Twins
Clinical diagnosis of mild-moderate respiratory distress syndrome
requiring a fraction of inspired oxigen (FiO2 ) <0.40 to keep oxygen saturation of 90%-95%
a chest X-ray suggestive of early stage hyaline membrane disease, (i.e. mild microgranulia and air bronchogram)

Exclusion Criteria:

pneumothorax
pneumomediastinum
surgical diseases
cardiac diseases
intraventricular hemorrage
major congenital defects

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Minutes

Maximum Age

6 Hours

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Long Chen, MD	Department of Pediatrics, Daping Hospital, Research Institute of Surgery, Third Military Medical University,	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Pediatrics, Daping Hospital, Research Institute of Surgery, Third Military Medical University		Chongqing	Chongqing Municipality	400042	China

Condition Browse Module

MeSH Terms

ID	Term
D012127	Respiratory Distress Syndrome, Newborn
D012128	Respiratory Distress Syndrome

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders
D007235	Infant, Premature, Diseases

Browse Leaves

Not provided

Browse Branches

Not provided