Clinical Trials Logo
  1. Home
  2. RSV Infection
  3. NCT03171142
  4. Details
NCT03171142 Clinical Trial

Effect of Heliox on RSV Bronchiolitis

RSV Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03171142
Other study ID # R/17.01.55
Secondary ID
Status Completed
Phase Phase 3
First received May 24, 2017
Last updated May 26, 2017
Start date May 1, 2015
Est. completion date May 1, 2017

Study information
Verified date May 2017
Source Mansoura University Children Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.

Recruitment information / eligibility
Status Completed
Enrollment 104
Est. completion date May 1, 2017
Est. primary completion date August 1, 2016
Accepts healthy volunteers No
Gender All
Age group 1 Month to 2 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Heliox
Heliox (21:79) via nasal cannula 2 litter per minutes
• Air
Air 21% via nasal cannula 2 litter per minutes

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wael Seliem

Outcome
Type Measure Description Time frame Safety issue
Primary Improvement in oxygenation Arterial blood samples will be withdrawn through an arterial stab to determine partial pressure of arterial oxygen (PaO2) change from baseline at 24 hours after treatment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 improvement of respiratory distress measured by the Modified Wood's Clinical Asthma Score change from baseline at 24 hours after treatment
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03698084 - RESCEU: Defining the Burden of RSV Disease
Recruiting NCT05550545 - Infant RSV Infections and Health-related Quality of Life of Families
Completed NCT05587478 - A Study of EDP-323 in Healthy Subjects Phase 1
Recruiting NCT06180993 - Evaluation of the Effectiveness and Impact of Nirsevimab Administered as Routine Immunization
Suspended NCT03909867 - Emission Patterns of Respiratory Syncytial Virus
Recruiting NCT06259487 - Coordinated Vaccination Against RSV and Influenza in Patients With Chronic Heart Failure and Its Impact on Prognosis. N/A
Not yet recruiting NCT04144816 - Predictors of Respiratory Syncytial Virus (RSV) Hospitalizations in Infants
Completed NCT01090557 - Exhaled Nitric Oxide in Respiratory Syncytial Virus (RSV) Bronchiolitis: a Pilot Study N/A
Terminated NCT01475305 - Intranasal Challenge of Healthy Adults With Respiratory Syncytial Virus (RSV) Phase 1
Not yet recruiting NCT05928507 - FINDER® Instrument and FINDER® FLU A/B, RSV, SARS-CoV-2 Test Clinical Evaluation Protocol
Completed NCT03062917 - Nasal and Bronchial Absorption Sampling in RSV Bronchiolitis N/A
Completed NCT03691623 - A Phase 2a Study to Evaluate EDP-938 in the Virus Challenge Model Phase 2
Completed NCT03387137 - Evaluating the Infectivity, Safety, and Immunogenicity of a Respiratory Syncytial Virus Vaccine (RSV 6120/∆NS2/1030s) in RSV-Seropositive Children and RSV-Seronegative Infants and Children Phase 1
Completed NCT05070975 - Severity of RSV Infections in Twins
Recruiting NCT04938830 - Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007) Phase 3
Recruiting NCT05568706 - A Study of EDP-938 in Non-hospitalized Adults With RSV Who Are at High Risk for Complications. Phase 2
Completed NCT03755778 - Drug-Drug Interaction Study Between EDP-938, Itraconazole, Rifampin, and Quinidine in Healthy Subjects Phase 1
Completed NCT01483911 - ALX-0171 Phase I Study, Evaluating Single Ascending Dose and Multiple Dose in Healthy Male Volunteers Phase 1
Recruiting NCT06170242 - A Controlled Phase 2a Study to Evaluate the Efficacy of EDP-323 Against Respiratory Syncytial Virus Infection in a Virus Challenge Model Phase 2
Completed NCT03750383 - Drug-Drug Interaction Study Between EDP-938, Cyclosporine and Prednisone in Healthy Adult Subjects Phase 1