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Helium Oxygen Mixture in the Treatment of Meconium Aspiration Syndrome

Primary Purpose

Neonatal Meconium Aspiration

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

helium oxygen mixture

About this trial

This is an interventional treatment trial for Neonatal Meconium Aspiration focused on measuring helium oxygen mixture, Meconium aspiration syndrome

Eligibility Criteria

37 Weeks - 40 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

History of congenital or hereditary disease

Sites / Locations

Department of Pediatrics, Daping Hospital, Third Military Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

experimental group

matched group

Arm Description

Using helium oxygen mixture

Using air oxygen mixture

Outcomes

Primary Outcome Measures

blood gas analysis

Time detection after treatment

blood gas analysis

Secondary Outcome Measures

Inflammatory response index (IL-6,IL-8, TNF-a,CRP)

Full Information

NCT ID

NCT02620891

First Posted

November 12, 2015

Last Updated

January 3, 2020

Sponsor

Ma Juan

1. Study Identification

Unique Protocol Identification Number

NCT02620891

Brief Title

Helium Oxygen Mixture in the Treatment of Meconium Aspiration Syndrome

Official Title

Study on the Effect of Helium Oxygen Mixture in the Treatment of Meconium Aspiration Syndrome Parallel Synchronized Intermittent Mandatory Ventilation; Synchronous Maudatory Ventilation

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

February 1, 2015 (Actual)

Primary Completion Date

February 20, 2017 (Actual)

Study Completion Date

April 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Ma Juan

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neonatal Meconium Aspiration

Keywords

helium oxygen mixture, Meconium aspiration syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

experimental group

Arm Type

Active Comparator

Arm Description

Using helium oxygen mixture

Arm Title

matched group

Arm Type

No Intervention

Arm Description

Using air oxygen mixture

Intervention Type

Device

Intervention Name(s)

helium oxygen mixture

Other Intervention Name(s)

Air oxygen mixture

Primary Outcome Measure Information:

Title

blood gas analysis

Description

Time detection after treatment

Time Frame

2 hour

Title

blood gas analysis

Time Frame

6 hour

Title

blood gas analysis

Time Frame

12 hour

Title

blood gas analysis

Time Frame

24 hour

Title

blood gas analysis

Time Frame

48 hour

Secondary Outcome Measure Information:

Title

Inflammatory response index (IL-6,IL-8, TNF-a,CRP)

Time Frame

0 hour

Title

Inflammatory response index (IL-6,IL-8, TNF-a,CRP)

Time Frame

6 hour

Other Pre-specified Outcome Measures:

Title

Amplitude integrated electroencephalogram

Time Frame

28and 100 days

Title

Amplitude integrated electroencephalogram

Time Frame

100 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

37 Weeks

Maximum Age & Unit of Time

40 Weeks

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Department of Pediatrics, Daping Hospital, Third Military Medical University

City

Chongqing

State/Province

Chongqing

ZIP/Postal Code

400042

Country

China

12. IPD Sharing Statement

Learn more about this trial

Helium Oxygen Mixture in the Treatment of Meconium Aspiration Syndrome

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