Helium Oxygen Mixture in the Treatment of Meconium Aspira... | NCT02620891

Studies
Helium Oxygen Mixture in the Treatment of Meconium Aspiration Syndrome

NCT02620891

Sponsor

Ma Juan

Status

Completed

Last Update Posted

Jan 7, 2020Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Neonatal Meconium Aspiration

Interventions

helium oxygen mixture

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

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

Status Module

Record Verification Date

Jan 2020

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

Feb 1, 2015Actual

Primary Completion Date

Feb 20, 2017Actual

Completion Date

Apr 1, 2017Actual

First Submitted Date

Nov 12, 2015

First Submission Date that Met QC Criteria

Dec 2, 2015

First Posted Date

Dec 3, 2015Estimated

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

Jan 3, 2020

Last Update Posted Date

Jan 7, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ma Juan, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversitySponsor-Investigator

Lead Sponsor

Ma JuanOTHER

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

Helium-oxygen mixture(heliox) was suggested to be beneficial in meconium aspiration syndrome in previous studies，but the evidence was limited．The aim of the study was to assess the effectiveness of synchronize intermittent mandatory ventilation (SIMV) with heliox (70% helium and 30% oxygen) on length of ventilation(LoV) and cardiopulmonary protection in meconium aspiration syndrome.

Detailed Description

Not provided

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

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
experimental group	Active Comparator	Using helium oxygen mixture	Device: helium oxygen mixture
matched group	No Intervention	Using air oxygen mixture

Interventions

Name	Type	Description	Arm Group Labels	Other Names
helium oxygen mixture	Device		experimental group	Air oxygen mixture

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
blood gas analysis	Time detection after treatment	2 hour
blood gas analysis		6 hour
blood gas analysis		12 hour
blood gas analysis		24 hour
blood gas analysis		48 hour

Secondary Outcomes

Measure	Description	Time Frame
Inflammatory response index (IL-6,IL-8, TNF-a,CRP)		0 hour
Inflammatory response index (IL-6,IL-8, TNF-a,CRP)		6 hour

Other Outcomes

Measure	Description	Time Frame
Amplitude integrated electroencephalogram		28and 100 days
Amplitude integrated electroencephalogram		100 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject has the diagnosis of neonatal meconium aspiration syndrome
Subject has Synchronous instruction ventilation

Exclusion Criteria:

History of congenital or hereditary disease

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

37 Weeks

Maximum Age

40 Weeks

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

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

Type	Date	Date Unknown
Release	Jan 13, 2020
Unrelease	Jan 15, 2020
Release	Jan 15, 2020
Reset	Jan 28, 2020

Submission Tracking

Estimated Results First Submitted Date

Jan 13, 2020

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jan 13, 2020	Jan 15, 2020
Jan 15, 2020

Condition Browse Module

MeSH Terms

ID	Term
D008471	Meconium Aspiration Syndrome

Ancestor Terms

ID	Term
D055370	Lung Injury
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders

Browse Leaves

Not provided

Browse Branches

Not provided