Effect of Heliox on RSV Bronchiolitis

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03171142

Enrollment

104

Registered

2017-05-31

Start date

2015-05-01

Completion date

2017-05-01

Last updated

2017-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Bronchiolitis, RSV Infection

Keywords

Heliox

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.

Interventions

DRUGHeliox

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

DRUGAir

Air 21% via nasal cannula 2 litter per minutes

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Months to 2 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Improvement in oxygenation	change from baseline at 24 hours after treatment	Arterial blood samples will be withdrawn through an arterial stab to determine partial pressure of arterial oxygen (PaO2)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

Measure	Time frame	Description
improvement of respiratory distress	change from baseline at 24 hours after treatment	measured by the Modified Wood's Clinical Asthma Score

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026