Heliox in Preterm Infants With Respiratory Distress Syndrome

October 25, 2013 updated by: Yuan Shi, Third Military Medical University

Nasal Intermittent Positive Pressure Ventilation and Mechanical Ventilation With Heliox in Preterm Infants With Respiratory Distress Syndrome

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

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Chongqing, China
        • Daping Hospital and Research Institute of Surgery
    • Chongqing
      • China, Chongqing, China, 400042
        • Daping Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 8 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: heliox
Heliox is use in this group
heliox or oxygen is used in the two groups respectively
Placebo Comparator: Placebo
Oxygen is used in this group
heliox or oxygen is used in the two groups respectively

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
length of ventilation and risk of mechanical ventilation
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Yuan Shi, MD, PhD, Dpartment of Pediatrics, Daping Hospital, Third Military Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

December 7, 2012

First Submitted That Met QC Criteria

December 30, 2012

First Posted (Estimate)

January 3, 2013

Study Record Updates

Last Update Posted (Estimate)

October 28, 2013

Last Update Submitted That Met QC Criteria

October 25, 2013

Last Verified

October 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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