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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

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.

Condition or disease Intervention/treatment Phase
RSV Infection Acute Bronchiolitis Drug: Heliox Drug: Air Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Heliox on Infants With Respiratory Syncytial Virus Acute Bronchiolitis-A Revisit Study
Actual Study Start Date : May 1, 2015
Actual Primary Completion Date : August 1, 2016
Actual Study Completion Date : May 1, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Heliox

Arm Intervention/treatment
Active Comparator: Heliox group
receive Helium oxygen mixture 21:79 via nasal cannula 2L/min
Drug: Heliox
Heliox (21:79) via nasal cannula 2 litter per minutes

Active Comparator: Air group
receive oxygen 21%via nasal cannula 2L/min
Drug: Air
Air 21% via nasal cannula 2 litter per minutes




Primary Outcome Measures :
  1. 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    Arterial blood samples will be withdrawn through an arterial stab to determine partial pressure of arterial oxygen (PaO2)


Secondary Outcome Measures :
  1. improvement of respiratory distress [ Time Frame: change from baseline at 24 hours after treatment ]
    measured by the Modified Wood's Clinical Asthma Score



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Responsible Party: Wael Seliem, Associated Professor, Mansoura University Children Hospital
ClinicalTrials.gov Identifier: NCT03171142     History of Changes
Other Study ID Numbers: R/17.01.55
First Posted: May 31, 2017    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wael Seliem, Mansoura University Children Hospital:
Heliox

Additional relevant MeSH terms:
Bronchiolitis
Respiratory Syncytial Virus Infections
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases