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Bronchiolitis in infants and young children often requires respiraty support. In Denmark Continous Positive Airway Pressure ( CPAP) are routinely used in children with moderate-severe bronchiolitis. The aim of the study is to compare CPAP and High Flow Oxygenation Therapy (HFOT) as tools of respiratory support in infants and young children with bronchiolitis.
Infants and young children with moderate-severe bronchiolitis and are randomized to either CPAP or HFOT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continous Positive Airway Pressure | Active Comparator | CPAP is administered through a binasal tube fitted with a Benveniste gas jet administered with humified airflow. Start flow is 12-14 l/min and can be changed to maximum 15 or minimum 12 l/min. Oxygen can be supplied as needed to keep SpO2 (peripheral capillary Oxygen saturation) within acceptable limits. |
|
| High Flow Oxygenation Therapy | Active Comparator | HFOT is administered by optiflow Junior ( Fisher&Paykal Healthcare® Auckland, New Zealand) Start flow 12-14 l/min. Oxygen can be supplied as needed to keep Sp02 within acceptable limits |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optiflow Junior | Device | Humified air are dispensed through the system. Airflow, FiO2 (Fraction of inspired oxygen) , SpO2 (peripheral capillary Oxygen saturation) and respiratory rate are noted each hour. Progression of condition might lead to change of system og mechanical ventilation. poor tolerance might lead to change of system |
| Measure | Description | Time Frame |
|---|---|---|
| respiration rate | change in respiration rate ( RR) from preintervention value | after 6 12 18 24 and 48 hour of intervention |
| PCo2 | Change in PCo2 (partial pressure of carbon dioxide)from pre intervention value | after 6 12 24 and 48 hours of intervention |
| Modified asthma score (MWAS) | Change in MWAS from pre intervention value | Once daily as long as intervention precedes ( 1-14 days) |
| Measure | Description | Time Frame |
|---|---|---|
| treatment length | duration of need of intervention ( hours) | from beginning of intervention to discontinuation (1-14 days) |
| Hspitalization | duration of hospitalisation ( days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Signe VAhlkvist, MD PhD | Pediatric Award, Hospital of South West Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Lillebaelt | Kolding | 6000 | Denmark | |||
| Signe Vahlkvist |
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| ID | Term |
|---|---|
| D001988 | Bronchiolitis |
| ID | Term |
|---|---|
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
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|
| Continous Positive Airway Pressure | Device | Humified air are dispensed throug the system. Airflow, FiO2, SpO2 and respiratory rate are noted each hour. Progression of condition might lead to change of system or mechanical ventilation. Poor tolerance might lead to change of system. |
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| from hospitalization to release (1-21 days) |
| Intervention failure. | numbers of intervention failure defined as change of intervention or progression to need for intensive care/ mechanical ventilation. | from beginning of intervention to discontinuation.(1-14 days) |
| patient acceptance of intervention | VAS score of tolerance with intervention. 0 = worst possible acceptance 5 = fully acceptance | daily VAS score (0-5) from beginning of intervention to discontinuation (1-14 days) |
| Kolding |
| 6000 |
| Denmark |
| D012140 |
| Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |