Heliox in Preterm Infants With Respiratory Distress Syndrome | NCT01759316

Studies
Heliox in Preterm Infants With Respiratory Distress Syndrome

NCT01759316

Sponsor

Third Military Medical University

Status

Completed

Last Update Posted

Oct 28, 2013Estimated

Enrollment

36Actual

Phase

Not Applicable

Conditions

Respiratory Distress Syndrome

Interventions

heliox

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

Oct 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

Dec 2012

Primary Completion Date

Aug 2013Actual

Completion Date

Aug 2013Actual

First Submitted Date

Dec 7, 2012

First Submission Date that Met QC Criteria

Dec 30, 2012

First Posted Date

Jan 3, 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

Oct 25, 2013

Last Update Posted Date

Oct 28, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yuan Shi, Director, Head of Pediatrics, Principal Investigator, Clinical Professor, Third Military Medical UniversityPrincipal Investigator

Lead Sponsor

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

Heliox can lower respiratory resistance, improve the oxygenation, reduce respiratory distress and lung injury caused by mechanical ventilation.

Detailed Description

Heliox can improve the oxygenation, reduce respiratory distress and lung injury caused by mechanical ventilation.

Heliox has not been widely used. More studies on the effects and safety of Heliox in addition to NIPPV and mechanical ventilation should be tried.

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

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
heliox	Active Comparator	Heliox is use in this group	Other: heliox
Placebo	Placebo Comparator	Oxygen is used in this group	Other: heliox

Interventions

Name	Type	Description	Arm Group Labels	Other Names
heliox	Other	heliox or oxygen is used in the two groups respectively	Placebo heliox

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
length of ventilation and risk of mechanical ventilation	The primary outcome is the length of ventilation and risk of mechanical ventilation of participants.	participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Secondary Outcomes

Measure	Description	Time Frame
Transcutaneous blood gas analysis，ventilator parameters and lung inflammation cytokines		participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Gestational age more than 28 weeks and less than 32 weeks
Diagnosed as respiratory distress syndrome
Need to use NIPPV ventilation
No congenital diseases or hereditary diseases
With an informed consent form

Exclusion Criteria:

With congenital diseases or hereditary diseases
Intubated in the delivery room
Need surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

28 Weeks

Maximum Age

37 Weeks

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yuan Shi, MD, PhD	Dpartment of Pediatrics, Daping Hospital, Third Military Medical University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Daping Hospital		China	Chongqing Municipality	400042	China
Daping Hospital and Research Institute of Surgery

Condition Browse Module

MeSH Terms

ID	Term
D012128	Respiratory Distress Syndrome

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C038949	heliox

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided