Effect of Heliox on RSV Bronchiolitis

Wael Seliem

Status and phase: Completed; Phase 3

Conditions: Acute Bronchiolitis; RSV Infection

Treatments: Drug: Heliox; Drug: Air

Study type: Interventional

Funder types: Other

Identifiers

NCT03171142

R/17.01.55

Details and patient eligibility

About

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.

Enrollment: 104 patients

Sex: All

Ages: 1 month to 2 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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104 participants in 2 patient groups

Heliox group

Active Comparator group

Description:

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

Treatment:

Drug: Heliox

Air group

Active Comparator group

Description:

receive oxygen 21%via nasal cannula 2L/min

Treatment:

Drug: Air