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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bronchiolitis, Viral

Intervention / Treatment
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* Device: High flow humidified oxygen therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: standard therapy group<br>standard treatment of viral bronchiolitis with low flow oxygen. | |
| Experimental: high flow humidified oxygen group<br>treatment of viral bronchiolitis with high flow humidified oxygen therapy. | Device: High flow humidified oxygen therapy<br>* application of high flow humidified oxygen therapy at 2l/kg/min<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients requiring intubation and ventilation | number of patients (N) getting intubated | from time of enrollment to end of hospital stay (up to 6 months) | 
| Length of hospital stay | days (N) spent in hospital | from time of enrollment to end of hospital stay (up to 6 months) |