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

Not Applicable

Terminated

• Conditions: Bronchiolitis, Viral
• Interventions: Device: High flow humidified oxygen therapy

• Registration Number: NCT03252119
• Lead Sponsor: Chris Hani Baragwanath Academic Hospital

Brief Summary

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".

Detailed 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.

Study Timeline

• Study First Submitted: 2017-05-04
• Study Start: 2017-06-01
• Study First Submitted QC: 2017-08-14
• Study First Posted: 2017-08-17
• Primary Completion: 2018-08-31
• Study Completion: 2018-08-31
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-23
• Last Update Posted: 2019-07-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
high flow humidified oxygen group	High flow humidified oxygen therapy	treatment of viral bronchiolitis with high flow humidified oxygen therapy.

Primary Outcome Measures

Name	Time	Method
Effect of high flow humidified oxygen therapy on blood oxygen saturations	first 5 days post enrollment	Saturation of oxygen (% saturation) as measured by pulse oximeter
Effect of high flow humidified oxygen therapy on work of breathing	first 5 days post enrollment	Use of accessory muscles of respiration (present /not)
Effect of high flow humidified oxygen therapy on heart rate	first 5 days post enrollment	Pulse (n/min) measured by ECG monitor

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay	from time of enrollment to end of hospital stay (up to 6 months)	days (N) spent in hospital
Proportion of patients requiring intubation and ventilation	from time of enrollment to end of hospital stay (up to 6 months)	number of patients (N) getting intubated

Trial Locations

Locations (1)

Chris Hani Baragwanath Academic Hospital; 🇿🇦 Johannesburg, Gauteng, South Africa