RSV InfectionPhase 3NCT03171142
Effect of Heliox on RSV Bronchiolitis
A Phase 3 study testing Heliox and Air in people with RSV Infection and Acute Bronchiolitis, run by Wael Seliem.
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. Read more about this study
- Who is it for?
- Ages 1 month to 2 years
- Conditions the study is for
- RSV Infection, Acute Bronchiolitis
- What is being tested?
- Heliox and Air
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2015to 1 May 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age fro 1 month till 2 years
- RSV acute bronchiolitis without any supplemental oxygen.
Who cannot join
- oxygen supplement or mechanical ventilation requirement
- congenital anomalies of the heart
- chronic lung disease including bronchopulmonary dysplasia
- Failure to obtain an informed consent.
About this study
Official title: 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.
- Conditions
- RSV Infection, Acute Bronchiolitis
- Being tested
- Heliox, Air
- Keywords
- Heliox
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HelioxDrug
Heliox (21:79) via nasal cannula 2 litter per minutes
AirDrug
Air 21% via nasal cannula 2 litter per minutes
| Study group | Role | What they receive |
|---|---|---|
| Heliox group | Active comparator | receive Helium oxygen mixture 21:79 via nasal cannula 2L/min Receives: Drug: Heliox |
| Air group | Active comparator | receive oxygen 21%via nasal cannula 2L/min Receives: Drug: Air |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in oxygenation
Arterial blood samples will be withdrawn through an arterial stab to determine partial pressure of arterial oxygen (PaO2)
Measured: change from baseline at 24 hours after treatment
Secondary outcomes (1)
improvement of respiratory distress
measured by the Modified Wood's Clinical Asthma Score
Measured: change from baseline at 24 hours after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start1 May 2015
- Primary completion1 Aug 2016
- Study completion1 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RSV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wael Seliem
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wael Seliem, Mansoura University Children Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03171142
- Sponsor's protocol ID
- R/17.01.55
- Status last verified
- May 2017
- First submitted
- 24 May 2017
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Heliox on Infants With Respiratory Syncytial Virus Acute Bronchiolitis-A Revisit Study
- ClinicalTrials.gov ID
- NCT03171142
- Acronym / sponsor ID
- R/17.01.55
- Conditions
- RSV Infection, Acute Bronchiolitis
- Keywords
- Heliox
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Wael SeliemUniversity, hospital or other
- Study start
- 1 May 2015 (actual)
- Primary completion
- 1 Aug 2016 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 31 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heliox group | Active comparator | Drug: Helioxreceive Helium oxygen mixture 21:79 via nasal cannula 2L/min |
| Air group | Active comparator | Drug: Airreceive oxygen 21%via nasal cannula 2L/min |
Who may qualify
- Ages
- 1 month to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age fro 1 month till 2 years
- RSV acute bronchiolitis without any supplemental oxygen.
Key exclusion criteria (4 listed)
- oxygen supplement or mechanical ventilation requirement
- congenital anomalies of the heart
- chronic lung disease including bronchopulmonary dysplasia
- Failure to obtain an informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HelioxHeliox (21:79) via nasal cannula 2 litter per minutes | Drug | Heliox group |
| AirAir 21% via nasal cannula 2 litter per minutes | Drug | Air group |
Primary outcome
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)
1 secondary outcome
improvement of respiratory distress
Time frame: change from baseline at 24 hours after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Heliox and Air in people with RSV Infection and Acute Bronchiolitis, run by Wael Seliem.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in oxygenation (time frame: change from baseline at 24 hours after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2017.