Effect of Heliox on RSV Bronchiolitis | NCT03171142

Studies
Effect of Heliox on RSV Bronchiolitis

NCT03171142

Sponsor

Wael Seliem

Status

Completed

Last Update Posted

May 31, 2017Actual

Enrollment

104Actual

Phase

Phase 3

Conditions

RSV Infection
Acute Bronchiolitis

Interventions

Heliox
Air

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2015Actual

Primary Completion Date

Aug 1, 2016Actual

Completion Date

May 1, 2017Actual

First Submitted Date

May 24, 2017

First Submission Date that Met QC Criteria

May 26, 2017

First Posted Date

May 31, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 26, 2017

Last Update Posted Date

May 31, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

104Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Heliox group	Active Comparator	receive Helium oxygen mixture 21:79 via nasal cannula 2L/min	Drug: Heliox
Air group	Active Comparator	receive oxygen 21%via nasal cannula 2L/min	Drug: Air

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Heliox	Drug	Heliox (21:79) via nasal cannula 2 litter per minutes	Heliox group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

2 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018357	Respiratory Syncytial Virus Infections

Ancestor Terms

ID	Term
D018186	Pneumovirus Infections
D018184	Paramyxoviridae Infections
D018701	Mononegavirales Infections
D012327	RNA Virus Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C038949	heliox
D000388	Air

Ancestor Terms

ID	Term
D001272	Atmosphere
D004777	Environment
D055669	Ecological and Environmental Phenomena
D001686	Biological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided