NCT01759316

Brief Summary

Heliox can lower respiratory resistance, improve the oxygenation, reduce respiratory distress and lung injury caused by mechanical ventilation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

December 1, 2012

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2012

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 3, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

October 28, 2013

Status Verified

October 1, 2013

Enrollment Period

8 months

First QC Date

December 7, 2012

Last Update Submit

October 25, 2013

Conditions

Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

  • length of ventilation and risk of mechanical ventilation

    The primary outcome is the length of ventilation and risk of mechanical ventilation of participants.

    participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Secondary Outcomes (1)

  • Transcutaneous blood gas analysis，ventilator parameters and lung inflammation cytokines

    participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Study Arms (2)

heliox

ACTIVE COMPARATOR

Heliox is use in this group

Other: heliox

Placebo

PLACEBO COMPARATOR

Oxygen is used in this group

Other: heliox

Interventions

helioxOTHER

heliox or oxygen is used in the two groups respectively

Placeboheliox

Eligibility Criteria

Age28 Weeks - 37 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Gestational age more than 28 weeks and less than 32 weeks
  • Diagnosed as respiratory distress syndrome
  • Need to use NIPPV ventilation
  • No congenital diseases or hereditary diseases
  • With an informed consent form

You may not qualify if:

  • With congenital diseases or hereditary diseases
  • Intubated in the delivery room
  • Need surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Daping Hospital

China, Chongqing Municipality, 400042, China

Location

Daping Hospital and Research Institute of Surgery

Chongqing, China

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

heliox

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Yuan Shi, MD, PhD

    Dpartment of Pediatrics, Daping Hospital, Third Military Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Head of Pediatrics, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

December 7, 2012

First Posted

January 3, 2013

Study Start

December 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

October 28, 2013

Record last verified: 2013-10

Locations

CN(2)