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Effect of Heliox on RSV Bronchiolitis

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ClinicalTrials.gov Identifier: NCT03171142
Recruitment Status : Completed
First Posted : May 31, 2017
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
Wael Seliem, Mansoura University Children Hospital

May 24, 2017
May 31, 2017
May 31, 2017
May 1, 2015
August 1, 2016   (Final data collection date for primary outcome measure)
Improvement in oxygenation [ Time Frame: change from baseline at 24 hours after treatment ]
Arterial blood samples will be withdrawn through an arterial stab to determine partial pressure of arterial oxygen (PaO2)
Same as current
No Changes Posted
improvement of respiratory distress [ Time Frame: change from baseline at 24 hours after treatment ]
measured by the Modified Wood's Clinical Asthma Score
Same as current
Not Provided
Not Provided
 
Effect of Heliox on RSV Bronchiolitis
Effect of Heliox on Infants With Respiratory Syncytial Virus Acute Bronchiolitis-A Revisit Study
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • RSV Infection
  • Acute Bronchiolitis
  • Drug: Heliox
    Heliox (21:79) via nasal cannula 2 litter per minutes
  • Drug: Air
    Air 21% via nasal cannula 2 litter per minutes
  • Active Comparator: Heliox group
    receive Helium oxygen mixture 21:79 via nasal cannula 2L/min
    Intervention: Drug: Heliox
  • Active Comparator: Air group
    receive oxygen 21%via nasal cannula 2L/min
    Intervention: Drug: Air
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
104
Same as current
May 1, 2017
August 1, 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
1 Month to 2 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT03171142
R/17.01.55
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Wael Seliem, Mansoura University Children Hospital
Wael Seliem
Not Provided
Not Provided
Mansoura University Children Hospital
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP