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Heliox in Preterm Infants With Respiratory Distress Syndrome

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ClinicalTrials.gov Identifier: NCT01759316
Recruitment Status : Completed
First Posted : January 3, 2013
Last Update Posted : October 28, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Heliox can lower respiratory resistance, improve the oxygenation, reduce respiratory distress and lung injury caused by mechanical ventilation.

Condition or disease Intervention/treatment
Respiratory Distress Syndrome Other: heliox

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nasal Intermittent Positive Pressure Ventilation and Mechanical Ventilation With Heliox in Preterm Infants With Respiratory Distress Syndrome
Study Start Date : December 2012
Primary Completion Date : August 2013
Study Completion Date : August 2013


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   28 Weeks to 37 Weeks   (Child)
Sexes Eligible for Study:   All
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 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01759316


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

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
First Posted: January 3, 2013    Key Record Dates
Last Update Posted: October 28, 2013
Last Verified: October 2013

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