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Effect of Heliox on RSV Bronchiolitis

Primary Purpose

RSV Infection, Acute Bronchiolitis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Heliox
Air
Sponsored by
Wael Seliem
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for RSV Infection focused on measuring Heliox

Eligibility Criteria

1 Month - 2 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age fro 1 month till 2 years
  • RSV acute bronchiolitis without any supplemental oxygen.

Exclusion Criteria:

  • oxygen supplement or mechanical ventilation requirement
  • congenital anomalies of the heart
  • chronic lung disease including bronchopulmonary dysplasia
  • Failure to obtain an informed consent.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Heliox group

    Air group

    Arm Description

    receive Helium oxygen mixture 21:79 via nasal cannula 2L/min

    receive oxygen 21%via nasal cannula 2L/min

    Outcomes

    Primary Outcome Measures

    Improvement in oxygenation
    Arterial blood samples will be withdrawn through an arterial stab to determine partial pressure of arterial oxygen (PaO2)

    Secondary Outcome Measures

    improvement of respiratory distress
    measured by the Modified Wood's Clinical Asthma Score

    Full Information

    First Posted
    May 24, 2017
    Last Updated
    May 26, 2017
    Sponsor
    Wael Seliem
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03171142
    Brief Title
    Effect of Heliox on RSV Bronchiolitis
    Official Title
    Effect of Heliox on Infants With Respiratory Syncytial Virus Acute Bronchiolitis-A Revisit Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    May 1, 2015 (Actual)
    Primary Completion Date
    August 1, 2016 (Actual)
    Study Completion Date
    May 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Wael Seliem

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Helium is an inert gas with a density almost one-seventh of that of air. Based on its properties breathing a mixture of helium and oxygen (heliox) will lead to a reduction in resistance through narrowed airways and consequently decreases the work of breathing. Participating infants with RSV acute bronchiolitis will be supplied with heliox (ration of 21 oxygen and 79 helium) delivered through a flow nasal cannula to evaluate heliox effect in improving their oxygenation. Heliox will act as an additive therapy to improve oxygenation in patients with lower respiratory tract infection caused by respiratory Syncytial Virus (RSV) and will decrease the need for more complicated therapies.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    RSV Infection, Acute Bronchiolitis
    Keywords
    Heliox

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    104 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Heliox group
    Arm Type
    Active Comparator
    Arm Description
    receive Helium oxygen mixture 21:79 via nasal cannula 2L/min
    Arm Title
    Air group
    Arm Type
    Active Comparator
    Arm Description
    receive oxygen 21%via nasal cannula 2L/min
    Intervention Type
    Drug
    Intervention Name(s)
    Heliox
    Intervention Description
    Heliox (21:79) via nasal cannula 2 litter per minutes
    Intervention Type
    Drug
    Intervention Name(s)
    Air
    Intervention Description
    Air 21% via nasal cannula 2 litter per minutes
    Primary Outcome Measure Information:
    Title
    Improvement in oxygenation
    Description
    Arterial blood samples will be withdrawn through an arterial stab to determine partial pressure of arterial oxygen (PaO2)
    Time Frame
    change from baseline at 24 hours after treatment
    Secondary Outcome Measure Information:
    Title
    improvement of respiratory distress
    Description
    measured by the Modified Wood's Clinical Asthma Score
    Time Frame
    change from baseline at 24 hours after treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Month
    Maximum Age & Unit of Time
    2 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age fro 1 month till 2 years RSV acute bronchiolitis without any supplemental oxygen. Exclusion Criteria: oxygen supplement or mechanical ventilation requirement congenital anomalies of the heart chronic lung disease including bronchopulmonary dysplasia Failure to obtain an informed consent.

    12. IPD Sharing Statement

    Learn more about this trial

    Effect of Heliox on RSV Bronchiolitis

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