- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01759316
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
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
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Chongqing, China
- Daping Hospital and Research Institute of Surgery
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Chongqing
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China, Chongqing, China, 400042
- Daping Hospital
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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 |
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Active Comparator: heliox
Heliox is use in this group
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heliox or oxygen is used in the two groups respectively
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Placebo Comparator: Placebo
Oxygen is used in this group
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heliox or oxygen is used in the two groups respectively
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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
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The primary outcome is the length of ventilation and risk of mechanical ventilation of participants.
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participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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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
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participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Lixue
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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