Bronchiolitis, Viral
Conditions
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.
Interventions
DEVICEHigh flow humidified oxygen therapy
application of high flow humidified oxygen therapy at 2l/kg/min
Sponsors
Chris Hani Baragwanath Academic Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 2 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of high flow humidified oxygen therapy on work of breathing | during first 5 days post enrollment | Respiratory rate (n/min) |
| 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 heart rate | first 5 days post enrollment | Pulse (n/min) measured by ECG monitor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Length of hospital stay | from time of enrollment to end of hospital stay (up to 6 months) | days (N) spent in hospital |
Countries
South Africa
Outcome results
None listed