Helium Oxygen Mixture in the Treatment of Meconium Aspiration Syndrome

January 3, 2020 updated by: Ma Juan

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400042
        • Department of Pediatrics, Daping Hospital, Third Military Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 months to 9 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • History of congenital or hereditary disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: experimental group
Using helium oxygen mixture
Device: helium oxygen mixture
Other Names:
  • Air oxygen mixture
No Intervention: matched group
Using air oxygen mixture

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Amplitude integrated electroencephalogram
Time Frame: 28and 100 days
28and 100 days
Amplitude integrated electroencephalogram
Time Frame: 100 days
100 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ma Juan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2015

Primary Completion (Actual)

February 20, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

November 12, 2015

First Submitted That Met QC Criteria

December 2, 2015

First Posted (Estimate)

December 3, 2015

Study Record Updates

Last Update Posted (Actual)

January 7, 2020

Last Update Submitted That Met QC Criteria

January 3, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MJuan

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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