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CompletedNCT03171142Updated May 31, 2017

Effect of Heliox on RSV Bronchiolitis

A Phase 3 interventional study of Heliox and Air in RSV Infection and Acute Bronchiolitis, sponsored by Wael Seliem. Completed. Open to participants aged 1 Month to 2 Years. Per ClinicalTrials.gov, last updated 2017-05-31.

Sponsored by Wael Seliem · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years after the study started (first participant enrolled May 2015, registered May 2017).
Phase
Phase 3
Study type
Interventional
Enrollment
104
Allocation
Randomized
Ages
1 Month to 2 Years
Sex
All
01

Study 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.

02

Conditions studied

  • RSV Infection
  • Acute Bronchiolitis

Keywords

  • Heliox
03

In context

Respiratory Syncytial Virus Infections

302 studies on the registry are indexed under Respiratory Syncytial Virus Infections; 48 are open to participants now.

This study's enrollment of 104 is above the median of 89 across 219 interventional studies indexed under Respiratory Syncytial Virus Infections.

Browse Respiratory Syncytial Virus Infections studies →

Lead sponsor

This is the only study on the registry with Wael Seliem as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month to 2 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age fro 1 month till 2 years
  • RSV acute bronchiolitis without any supplemental oxygen.

Exclusion criteria

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
104 participants (actual)

Study arms

  • Active comparator
    Heliox group

    receive Helium oxygen mixture 21:79 via nasal cannula 2L/min

    Drug: Heliox

  • Active comparator
    Air group

    receive oxygen 21%via nasal cannula 2L/min

    Drug: Air

Interventions

  • DrugHeliox

    Heliox (21:79) via nasal cannula 2 litter per minutes

  • DrugAir

    Air 21% via nasal cannula 2 litter per minutes

06

What researchers measure

Primary outcomes

  1. Improvement in oxygenation

    Arterial blood samples will be withdrawn through an arterial stab to determine partial pressure of arterial oxygen (PaO2)

    Time frame: change from baseline at 24 hours after treatment

Secondary outcomes

  1. improvement of respiratory distress

    measured by the Modified Wood's Clinical Asthma Score

    Time frame: change from baseline at 24 hours after treatment

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03171142
Lead sponsor
Wael Seliem
Responsible party
Wael Seliem (Associated Professor, Mansoura University Children Hospital) — Sponsor-investigator
First posted
May 31, 2017
Start date
May 1, 2015
Primary completion
Aug 1, 2016
Completion
May 1, 2017
Last update
May 31, 2017

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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