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Slow recruitment
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Infants with viral bronchiolitis are currently treated with oxygen therapy if oxygen saturation is low. In earlier observational clinical studies, the use of high flow nasal cannulae therapy in infants with bronchiolitis has been associated with a decreased rate of intubation and intensive care. This study is a randomized controlled trial in two pediatric university hospitals in Finland comparing high flow nasal cannulae therapy to usual oxygen therapy in infants with bronchiolitis.
Infants with viral bronchiolitis are currently treated with oxygen therapy if oxygen saturation is low. In earlier observational clinical studies, the use of high flow nasal cannulae therapy in infants with bronchiolitis has been associated with a decreased rate of intubation and intensive care. This study is a randomized controlled trial in five pediatric university hospitals in Finland comparing high flow nasal cannulae therapy to usual oxygen therapy in infants with bronchiolitis.
The investigators will recruit 160 infants who require oxygen therapy (oxygen saturation <92%) during hospitalization due to a viral bronchiolitis. The participants are randomized to receive oxygen therapy either with high flow or ordinary nasal cannula.The infants are closely observed by study physicians for clinical parameters. The primary end point is treatment failure (need for change of respiratory support method). Secondary endpoints are respiratory rate (RR) and oxygen saturation (%) at specific measuring points, time from randomisation to end of oxygen therapy and time from randomisation to discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual oxygen therapy | Active Comparator | Oxygen therapy with normal nasal cannula (for example MedKit Finland) 0-2 l/min |
|
| High flow oxygen therapy | Experimental | High flow nasal cannula oxygen therapy with Airvo (TM, Fisher & Paykel Healthcare) device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Airvo (TM, Fisher & Paykel Healthcare) - High flow oxygen therapy | Device | High flow nasal cannula therapy with Airvo (TM, Fisher & Paykel Healthcare) device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with treatment failure | Treatment failure = need for change of respiratory support method | 720 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory rate measured by the study physician/nurse | At 30 min, 60 min, 90 min, 4 hours, 8 hours | |
| Oxygen saturation (%) | At 30 min, 60 min, 90 min, 4 hours, 8 hours | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marjo Renko, MD, PhD | University of Oulu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Hospital Jyväskylä | Jyväskylä | Finland | ||||
| Oulu Unversity Hospital |
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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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| MedKit Finland - Usual oxygen therapy | Device | Oxygen therapy with normal nasal cannula (for example MedKit Finland) 0-2 l/min |
|
| Time from randomisation to end of oxygen therapy |
| At 30 min, 60 min, 90 min, 4 hours, 8 hours |
| Time from hospital admission to discharge (hours) | The date and time for admission and discharge will be registered for each participant and time from hospital admission to discharge is then calculated in hours and compared between the study groups. | 720 hours |
| Number of participants needing admission to intensive care unit (ICU) | The number of participants needing admission to intensive care unit (ICU) will be registered in both treatment groups and that number divided by the total number of participants in the groups (percentages) are then compared between the study groups. | 720 hours |
| Oulu |
| Finland |
| Seinäjoki Central Hospital | Seinäjoki | Finland |
| Tampere University Hospital | Tampere | Finland |
| D012140 |
| Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |