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Completed

NCT Number: NCT03171142

Effect of Heliox on RSV Bronchiolitis

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.

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Key information

Conditions

RSV Infection Acute Bronchiolitis Infections Mononegavirales Infections Paramyxoviridae Infections Pneumovirus Infections RNA Virus Infections Respiratory Syncytial Virus Infections Virus Diseases

Age range

1 month–2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Heliox

Drug

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

Air

Drug

Air 21% via nasal cannula 2 litter per minutes

Primary outcomes

  1. Improvement in oxygenation

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    Arterial blood samples will be withdrawn through an arterial stab to determine partial pressure of arterial oxygen (PaO2)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

  1. improvement of respiratory distress

    Time frame: change from baseline at 24 hours after treatment

    measured by the Modified Wood's Clinical Asthma Score

Sponsors and collaborators

Lead sponsor

Wael Seliem

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
May 31, 2017
Registry last updated
May 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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