Comparison of High Flow Oxygenation Therapy and CPAP in Children With Bronchiolitis.

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of High Flow Oxygenation Therapy and CPAP in Children With Bronchiolitis.

Conditions
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Respiratory Syncytial Virus Bronchiolitis

Intervention / Treatment
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* Device: Optiflow Junior
* Device: Continous Positive Airway Pressure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: infants and children with moderate respiratoric syncytial virus bronchiolitis or other viral bronchiolitis and need of respiratory support. ( clinical decision) Exclusion Criteria: severe bronchiolitis with P C02 > 9, decreased consciusness and risk for early progression to intensive therapy.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 24 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: Continous Positive Airway Pressure<br>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. | Device: Continous Positive Airway Pressure<br>* 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.<br>* Other names: CPAP;|
| Active Comparator: High Flow Oxygenation Therapy<br>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 | Device: Optiflow Junior<br>* 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<br>* Other names: HFOT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Continuous Positive Airway Pressure, High Flow Oxygenation therapy, Bronchiolitis, Children