Heliox for Neonate With Acute Respiratory Distress Syndrome (ARDS)

NCT ID: NCT03217149

Last Updated: 2017-07-13

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2020-08-30

Brief Summary

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Acute respiratory distress syndrome (ARDS) in neonates has been defined, the role of heliox is not clear.This study aimed to determine whether ARDS neonate would benefit from heliox when oxygenation deteriorated on mechanical ventilation and to identify any potential risk factors related to mortality.

Detailed Description

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Acute respiratory distress syndrome (ARDS) can result in severe hypoxemia refractory to mechanical ventilation, mechanical ventilation including high frequency oscillation ventilation is the main method. But it is partial unuseful.

Conditions

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ARDS

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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heliox combined with mechanical ventilation (MV)

heliox combined with mechanical ventilation (MV) is given to infant with ARDS

Group Type EXPERIMENTAL

heliox combined with MV

Intervention Type DRUG

heliox combined with MV is given to infant with ARDS

mechanical ventilation

mechanical ventilation (MV) is given to infant with ARDS

Group Type ACTIVE_COMPARATOR

MV

Intervention Type DRUG

MV is given to infant with ARDS

Interventions

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heliox combined with MV

heliox combined with MV is given to infant with ARDS

Intervention Type DRUG

MV

MV is given to infant with ARDS

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. infant less than 28 days
2. diagnosis of ARDS
3. informed parental consent has been obtained

Exclusion Criteria

1. major congenital malformations or complex congenital heart disease
2. transferred out of the neonatal intensive care unit without treatment
Minimum Eligible Age

30 Minutes

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Ma Juan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shi Yuan, PhD,MD

Role: STUDY_DIRECTOR

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

Locations

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Department of Pediatrics, Daping Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ma Juan, MD

Role: CONTACT

13883559467

Ma Juan, MD

Role: CONTACT

1388.559467

Facility Contacts

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Juan Ma, physician

Role: primary

18680887330

Other Identifiers

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heliox for ARDS

Identifier Type: -

Identifier Source: org_study_id

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