NCT03217149

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 13, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2020

Completed
Last Updated

July 13, 2017

Status Verified

July 1, 2017

Enrollment Period

3 years

First QC Date

July 12, 2017

Last Update Submit

July 12, 2017

Conditions

ARDS

Outcome Measures

Primary Outcomes (1)

  • death

    death

    within 100 days

Secondary Outcomes (1)

  • Bayley Scales of Infant Development

    at 2 months old and 2 years old

Study Arms (2)

heliox combined with mechanical ventilation (MV)

EXPERIMENTAL

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

Drug: heliox combined with MV

mechanical ventilation

ACTIVE COMPARATOR

mechanical ventilation (MV) is given to infant with ARDS

Drug: MV

Interventions

heliox combined with MVDRUG

heliox combined with MV is given to infant with ARDS

heliox combined with mechanical ventilation (MV)
MVDRUG

MV is given to infant with ARDS

mechanical ventilation

Eligibility Criteria

Age30 Minutes - 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • infant less than 28 days
  • diagnosis of ARDS
  • informed parental consent has been obtained

You may not qualify if:

  • major congenital malformations or complex congenital heart disease
  • transferred out of the neonatal intensive care unit without treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pediatrics, Daping Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

Study Officials

  • Shi Yuan, PhD,MD

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

    STUDY DIRECTOR

Central Study Contacts

Ma Juan, MD

CONTACT

13883559467476679422@qq.com

Ma Juan, MD

CONTACT

1388.559467476679422@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 12, 2017

First Posted

July 13, 2017

Study Start

September 1, 2017

Primary Completion

August 30, 2020

Study Completion

August 30, 2020

Last Updated

July 13, 2017

Record last verified: 2017-07

Locations

CN(1)