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Heliox in Preterm Infants With Respiratory Distress Syndrome

This study is currently recruiting participants.
Verified January 2013 by Third Military Medical University
Sponsor:
Information provided by (Responsible Party):
Yuan Shi, Third Military Medical University
ClinicalTrials.gov Identifier:
NCT01759316
First received: December 7, 2012
Last updated: January 3, 2013
Last verified: January 2013
History of Changes
  Purpose

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


Condition Intervention
Respiratory Distress Syndrome
 Other: heliox

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nasal Intermittent Positive Pressure Ventilation and Mechanical Ventilation With Heliox in Preterm Infants With Respiratory Distress Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Premature Babies
Drug Information available for: Heliox
U.S. FDA Resources

Further study details as provided by Third Military Medical University:

Primary Outcome Measures:
  • mortality [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks ] [ Designated as safety issue: Yes ]
    The primary outcome is the mortality participants during the hospital stay


Secondary Outcome Measures:
  • Oxygenation index (OI) [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks ] [ Designated as safety issue: Yes ]
    OI will be important for newborn infants


Other Outcome Measures:
  • Time of respiratory support [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks ] [ Designated as safety issue: Yes ]
    Time of respiratory support


Estimated Enrollment: 60
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: heliox
Heliox is use in this group
 Other: heliox
heliox or oxygen is used in the two groups respectively
Placebo Comparator: Placebo
Oxygen is used in this group
 Other: heliox
heliox or oxygen is used in the two groups respectively

Detailed Description:

Heliox can lower respiratory resistance, 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 mechical ventilation should be tried.

  Eligibility

Ages Eligible for Study:   28 Weeks to 37 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • With congenital diseases or hereditary diseases
  • With ventricular hemorrhage
  • Need surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01759316

Contacts
Contact: Li Xue 13360268550 965865947@qq.com

Locations
China, Chongqing
Daping Hospital Recruiting
China, Chongqing, China, 400042
Contact: Lixue     13360268550     965865947@qq.com    
China
Daping Hospital and Research Institute of Surgery Recruiting
Chongqing, China
Sponsors and Collaborators
Third Military Medical University
Investigators
Study Chair: Yuan Shi, MD, PhD Dpartment of Pediatrics, Daping Hospital, Third Military Medical University
  More Information

No publications provided

Responsible Party: Yuan Shi, Director, Head of Pediatrics, Principal Investigator, Clinical Professor, Third Military Medical University
ClinicalTrials.gov Identifier: NCT01759316     History of Changes
Other Study ID Numbers: Lixue
Study First Received: December 7, 2012
Last Updated: January 3, 2013
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
 Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on May 22, 2013