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Helium Oxygen Mixture in the Treatment of Meconium Aspiration Syndrome

NCT ID: NCT02620891

Last Updated: 2020-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-01

Study Completion Date

2017-04-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Neonatal Meconium Aspiration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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experimental group

Using helium oxygen mixture

Group Type ACTIVE_COMPARATOR

helium oxygen mixture

Intervention Type DEVICE

matched group

Using air oxygen mixture

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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helium oxygen mixture

Intervention Type DEVICE

Other Intervention Names

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Air oxygen mixture

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* History of congenital or hereditary disease
Minimum Eligible Age

37 Weeks

Maximum Eligible Age

40 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ma Juan

OTHER

Sponsor Role lead

Responsible Party

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Ma Juan

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

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Department of Pediatrics, Daping Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, China

Site Status

Countries

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China

Other Identifiers

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MJuan

Identifier Type: -

Identifier Source: org_study_id

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