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Heliox in Preterm Infants With Respiratory Distress Syndrome

Primary Purpose

Respiratory Distress Syndrome

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
heliox
Sponsored by
Third Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome

Eligibility Criteria

28 Weeks - 37 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • Daping Hospital
  • Daping Hospital and Research Institute of Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

heliox

Placebo

Arm Description

Heliox is use in this group

Oxygen is used in this group

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Transcutaneous blood gas analysis，ventilator parameters and lung inflammation cytokines

Full Information

First Posted
December 7, 2012
Last Updated
October 25, 2013
Sponsor
Third Military Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01759316
Brief Title
Heliox in Preterm Infants With Respiratory Distress Syndrome
Official Title
Nasal Intermittent Positive Pressure Ventilation and Mechanical Ventilation With Heliox in Preterm Infants With Respiratory Distress Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Military Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Heliox can lower respiratory resistance, improve the oxygenation, reduce respiratory distress and lung injury caused by mechanical ventilation.
Detailed Description
Heliox can improve the oxygenation, reduce respiratory distress and lung injury caused by mechanical ventilation. Heliox has not been widely used. More studies on the effects and safety of Heliox in addition to NIPPV and mechanical ventilation should be tried.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
heliox
Arm Type
Active Comparator
Arm Description
Heliox is use in this group
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oxygen is used in this group
Intervention Type
Other
Intervention Name(s)
heliox
Intervention Description
heliox or oxygen is used in the two groups respectively
Primary Outcome Measure Information:
Title
length of ventilation and risk of mechanical ventilation
Description
The primary outcome is the length of ventilation and risk of mechanical ventilation of participants.
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary Outcome Measure Information:
Title
Transcutaneous blood gas analysis，ventilator parameters and lung inflammation cytokines
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
28 Weeks
Maximum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: With congenital diseases or hereditary diseases Intubated in the delivery room Need surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuan Shi, MD, PhD
Organizational Affiliation
Dpartment of Pediatrics, Daping Hospital, Third Military Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Daping Hospital
City
China
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Facility Name
Daping Hospital and Research Institute of Surgery
City
Chongqing
Country
China

12. IPD Sharing Statement

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Heliox in Preterm Infants With Respiratory Distress Syndrome

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