High Flow Nasal Cannula Use in Infants With Bronchiolitis

Study Overview
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Brief Summary
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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.

Detailed Description
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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 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.

Official Title
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High Flow Humified Nasal Cannula Oxygen Therapy in Infants Younger Than 6 Months of Age With Viral Bronchiolitis Compared to Usual Oxygen Therapy : a Randomized Controlled Trial

Conditions
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Bronchiolitis

Intervention / Treatment
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* Device: Airvo (TM, Fisher & Paykel Healthcare) - High flow oxygen therapy
* Device: MedKit Finland - Usual oxygen therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Admission to pediatric ward due to a presumed viral bronchiolitis Need of oxygen therapy (oxygen saturation < 92%) Exclusion Criteria: Pertussis Needs intubation or CPAP on admission Severe congenital heart defect Down's syndrome

Ages Eligible for Study
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Maximum Age: 6 Months

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 |
| --- | --- |
| Active Comparator: Usual oxygen therapy<br>Oxygen therapy with normal nasal cannula (for example MedKit Finland) 0-2 l/min | Device: MedKit Finland - Usual oxygen therapy<br>* Oxygen therapy with normal nasal cannula (for example MedKit Finland) 0-2 l/min<br>|
| Experimental: High flow oxygen therapy<br>High flow nasal cannula oxygen therapy with Airvo (TM, Fisher & Paykel Healthcare) device | Device: Airvo (TM, Fisher & Paykel Healthcare) - High flow oxygen therapy<br>* High flow nasal cannula therapy with Airvo (TM, Fisher & Paykel Healthcare) device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with treatment failure | Treatment failure = need for change of respiratory support method | 720 hours | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infant, high flow nasal cannulae, oxygen therapy, bronchiolitis