Effect of Heliox on RSV Bronchiolitis
Effect of Heliox on Infants With Respiratory Syncytial Virus Acute Bronchiolitis-A Revisit Study
1 other identifier
interventional
104
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedFirst Submitted
Initial submission to the registry
May 24, 2017
CompletedFirst Posted
Study publicly available on registry
May 31, 2017
CompletedMay 31, 2017
May 1, 2017
1.3 years
May 24, 2017
May 26, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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Arterial blood samples will be withdrawn through an arterial stab to determine partial pressure of arterial oxygen (PaO2)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 Outcomes (1)
improvement of respiratory distress
change from baseline at 24 hours after treatment
Study Arms (2)
Heliox group
ACTIVE COMPARATORreceive Helium oxygen mixture 21:79 via nasal cannula 2L/min
Air group
ACTIVE COMPARATORreceive oxygen 21%via nasal cannula 2L/min
Interventions
Eligibility Criteria
You may qualify if:
- Age fro 1 month till 2 years
- RSV acute bronchiolitis without any supplemental oxygen.
You may not qualify if:
- oxygen supplement or mechanical ventilation requirement
- congenital anomalies of the heart
- chronic lung disease including bronchopulmonary dysplasia
- Failure to obtain an informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wael Seliemlead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associated Professor
Study Record Dates
First Submitted
May 24, 2017
First Posted
May 31, 2017
Study Start
May 1, 2015
Primary Completion
August 1, 2016
Study Completion
May 1, 2017
Last Updated
May 31, 2017
Record last verified: 2017-05