High Flow Oxygen Therapy vs Standard Care in Infants With Viral Bronchiolitis

Chris Hani Baragwanath Academic Hospital

Status: Terminated

Conditions: Bronchiolitis, Viral

Treatments: Device: High flow humidified oxygen therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03252119

M170234

Details and patient eligibility

About

A randomized control trial of 130 infants admitted to the paediatric high care admission ward will be enrolled, and randomized to either "high flow humidified oxygen" or "standard therapy".

Full description

A randomized control trial of 130 infants admitted to the paediatric high care admission ward will be enrolled. Infants between 1 month and 2 years of age who fulfill criteria for enrollment shall be considered eligible. Informed consent from parents or legal guardians shall be obtained. Infants shall be randomized to either "standard therapy" or "high flow humidified oxygen". Measurements of heart rate, respiratory rate, work of breathing (Tal score and WCAS), oxygen saturation and oxygen requirements shall be recorded.

Enrollment: 28 patients

Sex: All

Ages: 1 month to 2 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of viral bronchiolitis
• Not requiring intubation and ventilation
• Admitted to high care unit
• With moderate/severe respiratory distress (Tal score >6)
• Saturations <92% in room air

Exclusion criteria

• congenital cardiac disease
• presence of multiorgan failure/multisystemic disease
• previously ventilated
• craniofacial abnormalities
• nasal pathology
• decreased level of consciousness
• Ex-prem <34 weeks
• Possible impending respiratory failure

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

standard therapy group

No Intervention group

Description:

standard treatment of viral bronchiolitis with low flow oxygen.

high flow humidified oxygen group

Experimental group

Description:

treatment of viral bronchiolitis with high flow humidified oxygen therapy.

Treatment:

Device: High flow humidified oxygen therapy