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NCT03171142 Clinical Trial

Effect of Heliox on RSV Bronchiolitis

RSV Infection Clinical Trial

Official title:
Effect of Heliox on Infants With Respiratory Syncytial Virus Acute Bronchiolitis-A Revisit Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03171142
Other study ID # R/17.01.55
Secondary ID
Status Completed
Phase Phase 3
First received May 24, 2017
Last updated May 26, 2017
Start date May 1, 2015
Est. completion date May 1, 2017

Study information
Verified date May 2017
Source Mansoura University Children Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 104
Est. completion date May 1, 2017
Est. primary completion date August 1, 2016
Accepts healthy volunteers No
Gender All
Age group 1 Month to 2 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Heliox
Heliox (21:79) via nasal cannula 2 litter per minutes
• Air
Air 21% via nasal cannula 2 litter per minutes

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wael Seliem

Outcome
Type Measure Description Time frame Safety issue
Primary Improvement in oxygenation Arterial blood samples will be withdrawn through an arterial stab to determine partial pressure of arterial oxygen (PaO2) change from baseline at 24 hours after treatment
Secondary improvement of respiratory distress measured by the Modified Wood's Clinical Asthma Score change from baseline at 24 hours after treatment
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