Effect of Heliox on RSV Bronchiolitis

• Sponsor: Wael Seliem (Other)
• Overall Status: Completed
• CT.gov ID: NCT03171142
• Collaborator: (none)
• Enrollment: 104
• Arms: 2
• Actual Duration (Months): 24

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
RSV Infection; Acute Bronchiolitis	Drug: Heliox; Drug: Air	Phase 3

Study Design

• Study Type: Interventional
• 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: Aug 1, 2016
• Actual Study Completion Date: May 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Improvement in oxygenation [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   Arterial blood samples will be withdrawn through an arterial stab to determine partial pressure of arterial oxygen (PaO2)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 [change from baseline at 24 hours after treatment]

   measured by the Modified Wood's Clinical Asthma Score

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Month to 2 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Wael Seliem

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wael Seliem, Associated Professor, Mansoura University Children Hospital
• ClinicalTrials.gov Identifier: NCT03171142
• Other Study ID Numbers: R/17.01.55
• First Posted: May 31, 2017
• Last Update Posted: May 31, 2017
• Last Verified: May 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Wael Seliem, Associated Professor, Mansoura University Children Hospital: Heliox
• Additional relevant MeSH terms: Bronchiolitis; Respiratory Syncytial Virus Infections

Study Results

No Results Posted as of May 31, 2017