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High flow oxygen therapy became available as standard care
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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".
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard therapy group | No Intervention | standard treatment of viral bronchiolitis with low flow oxygen. | |
| high flow humidified oxygen group | Experimental | treatment of viral bronchiolitis with high flow humidified oxygen therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High flow humidified oxygen therapy | Device | application of high flow humidified oxygen therapy at 2l/kg/min |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan M Murphy, FCPaed (SA) | University of the Witwatersrand, Johannesburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chris Hani Baragwanath Academic Hospital | Johannesburg | Gauteng | South Africa |
No plan to share data wit other researchers
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| ID | Term |
|---|---|
| D001990 | Bronchiolitis, Viral |
| ID | Term |
|---|---|
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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days (N) spent in hospital
| from time of enrollment to end of hospital stay (up to 6 months) |
| D014777 |
| Virus Diseases |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |