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Effect of Heliox on RSV Bronchiolitis

NCT ID: NCT03171142

Last Updated: 2017-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-01

Study Completion Date

2017-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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RSV Infection Acute Bronchiolitis

Keywords

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Heliox

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Heliox group

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

Group Type ACTIVE_COMPARATOR

Heliox

Intervention Type DRUG

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

Air group

receive oxygen 21%via nasal cannula 2L/min

Group Type ACTIVE_COMPARATOR

Air

Intervention Type DRUG

Air 21% via nasal cannula 2 litter per minutes

Interventions

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Heliox

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

Intervention Type DRUG

Air

Air 21% via nasal cannula 2 litter per minutes

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

1 Month

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wael Seliem

OTHER

Sponsor Role lead

Responsible Party

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Wael Seliem

Associated Professor

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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R/17.01.55

Identifier Type: -

Identifier Source: org_study_id