Heliox for Neonate With Acute Respiratory Distress Syndro... | NCT03217149

Studies
Heliox for Neonate With Acute Respiratory Distress Syndrome (ARDS)

NCT03217149

Sponsor

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

Status

Unknown status

Last Update Posted

Jul 13, 2017Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

ARDS

Interventions

heliox combined with MV
MV

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

Jul 2017

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

Sep 1, 2017Estimated

Primary Completion Date

Aug 30, 2020Estimated

Completion Date

Aug 30, 2020Estimated

First Submitted Date

Jul 12, 2017

First Submission Date that Met QC Criteria

Jul 12, 2017

First Posted Date

Jul 13, 2017Actual

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 12, 2017

Last Update Posted Date

Jul 13, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ma Juan, Principal Investigator, 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

Is FDA Regulated Device

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

Acute respiratory distress syndrome (ARDS) in neonates has been defined, the role of heliox is not clear.This study aimed to determine whether ARDS neonate would benefit from heliox when oxygenation deteriorated on mechanical ventilation and to identify any potential risk factors related to mortality.

Detailed Description

Acute respiratory distress syndrome (ARDS) can result in severe hypoxemia refractory to mechanical ventilation, mechanical ventilation including high frequency oscillation ventilation is the main method. But it is partial unuseful.

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

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
heliox combined with mechanical ventilation (MV)	Experimental	heliox combined with mechanical ventilation (MV) is given to infant with ARDS	Drug: heliox combined with MV
mechanical ventilation	Active Comparator	mechanical ventilation (MV) is given to infant with ARDS	Drug: MV

Interventions

Name	Type	Description	Arm Group Labels	Other Names
heliox combined with MV	Drug	heliox combined with MV is given to infant with ARDS	heliox combined with mechanical ventilation (MV)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
death	death	within 100 days

Secondary Outcomes

Measure	Description	Time Frame
Bayley Scales of Infant Development	the survival is assessed by Bayley Scales of Infant Development	at 2 months old and 2 years old

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

infant less than 28 days
diagnosis of ARDS
informed parental consent has been obtained

Exclusion Criteria:

major congenital malformations or complex congenital heart disease
transferred out of the neonatal intensive care unit without treatment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Minutes

Maximum Age

28 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ma Juan, MD	Contact	13883559467		476679422@qq.com
Ma Juan, MD	Contact	1388.559467		476679422@qq.com

Overall Officials

Name	Affiliation	Role
Shi Yuan, PhD,MD	Daping Hospital and the Research Institute of Surgery of the Third Military Medical University	Study Director

Locations

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

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided