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Heliox for Neonate With Acute Respiratory Distress Syndrome (ARDS)

Primary Purpose

ARDS

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
heliox combined with MV
MV
Sponsored by
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ARDS

Eligibility Criteria

30 Minutes - 28 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Pediatrics, Daping Hospital, Third Military Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

heliox combined with mechanical ventilation (MV)

mechanical ventilation

Arm Description

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

mechanical ventilation (MV) is given to infant with ARDS

Outcomes

Primary Outcome Measures

death
death

Secondary Outcome Measures

Bayley Scales of Infant Development
the survival is assessed by Bayley Scales of Infant Development

Full Information

First Posted
July 12, 2017
Last Updated
July 12, 2017
Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03217149
Brief Title
Heliox for Neonate With Acute Respiratory Distress Syndrome (ARDS)
Official Title
Heliox for Neonate With Acute Respiratory Distress Syndrome (ARDS): A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2017 (Anticipated)
Primary Completion Date
August 30, 2020 (Anticipated)
Study Completion Date
August 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
heliox combined with mechanical ventilation (MV)
Arm Type
Experimental
Arm Description
heliox combined with mechanical ventilation (MV) is given to infant with ARDS
Arm Title
mechanical ventilation
Arm Type
Active Comparator
Arm Description
mechanical ventilation (MV) is given to infant with ARDS
Intervention Type
Drug
Intervention Name(s)
heliox combined with MV
Intervention Description
heliox combined with MV is given to infant with ARDS
Intervention Type
Drug
Intervention Name(s)
MV
Intervention Description
MV is given to infant with ARDS
Primary Outcome Measure Information:
Title
death
Description
death
Time Frame
within 100 days
Secondary Outcome Measure Information:
Title
Bayley Scales of Infant Development
Description
the survival is assessed by Bayley Scales of Infant Development
Time Frame
at 2 months old and 2 years old

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Minutes
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: infant less than 28 days diagnosis of ARDS informed parental consent has been obtained Exclusion Criteria: major congenital malformations or complex congenital heart disease transferred out of the neonatal intensive care unit without treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ma Juan, MD
Phone
13883559467
Email
476679422@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ma Juan, MD
Phone
1388.559467
Email
476679422@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shi Yuan, PhD,MD
Organizational Affiliation
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Department of Pediatrics, Daping Hospital, Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Ma, physician
Phone
18680887330
Email
zoe330@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Heliox for Neonate With Acute Respiratory Distress Syndrome (ARDS)

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