Interest of High Flow Nasal Cannula (HFNC) Versus Non Invasive Ventilation During the Initial Management of Severe Bronchiolitis in Infants

Study Overview
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Brief Summary
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The purpose of the study is to evaluate prospectively the clinical benefits of High flow nasal canula (HFNC: 2l/kg/min) versus nasal CPAP( continuous positive airway pressure) (n-CPAP: 7 cmH2O) in the initial management of bronchiolitis in infants. Design: non-inferiority study, prospective, controlled, randomized, multi-center. Design: Infants less than 6 month admitted in pediatric intensive care unit for respiratory distress (mWCAS >3) secondary to bronchiolitis but not requiring mechanical ventilation will be randomized in two groups: n-CPAP(nasal continuous positive airway pressure) or HFNC during 24 hours. Conditions of measurements: Primary endpoint: Proportion of failure in both arms during the first 24 hours. Failure criteria: A raise of the Clinical score for respiratory distress (mWCAS) (1 point) or respiratory rate (10/min /H0 and above 60/min) or discomfort (EDIN) (1point /H0 and above 4) or apnea. Secondary outcomes: Assessment at H1, H12, H24 of mWCAS, respiratory and heart rate, EDIN score, skin lesions, FiO2 (fraction of inspired oxygen ) required to achieve an oxygen saturation between 94 and 97%, transcutaneous PCO2 (carbon dioxide partial pressure) (correlated to an initial gas analysis), Report SpO2 / FiO2 Statistic: Intention to treat Analysis. Expected number of patients: 71 per arm: 142 children. Study Schedule: October 2014-April 2016

Official Title
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Interest of High Flow Nasal Cannula (HFNC) Versus Non Invasive Ventilation During the Initial Management of Severe Bronchiolitis in Infants

Conditions
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Bronchiolitis

Intervention / Treatment
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* Device: HFNC
* Device: nCPAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age<6months bronchiolitis mWCAS > or=3 hospitalisation in pediatric intensive care unit signed consent form (2 parents) Exclusion Criteria: Intubated patient Neurological or cardiac disease

Ages Eligible for Study
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Minimum Age: 1 Day
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 |
| --- | --- |
| Experimental: HFNC treatment<br>HFNC : High flow nasal canula 24hours Patients will be treated by a High flow nasal canula (HFNC: 2l/kg/min) for the initial management of their bronchiolitis (24 hours) | Device: HFNC<br>* Hygh flow nasal canula HFNC<br>|
| Active Comparator: nCPAP treatment<br>nCPAP : nasal NCPAP Patients will be treated by a nasal CPAP (n-CPAP: 7 cmH2O) for the initial management of their bronchiolitis (24 hours) | Device: nCPAP<br>* nasal nCPAP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of failure | Proportion of failure in both arms during the first 24 hours. A raise of the Clinical score for respiratory distress (mWCAS) (1 point) or respiratory rate (10/min /H0 and above 60/min) or discomfort (EDIN) (1point /H0 and above 4) or apnea. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participants with an aggravation of the clinical score for respiratory distress arms | comparison of the clinical score for respiratory distress (mWCAS) in both arms | 1hour | 
| number of participants with an aggravation of the clinical score for respiratory distress arms | comparison of the clinical score for respiratory distress (mWCAS) in both arms | 12hours | 
| number of participants with an increase of the clinical score for respiratory distress arms | Assessment of Report Sp02/Fi02in both arms | 1 hour | 
| Comparison of the Report Sp02/Fi02 in both arms | Assessment of Report Sp02/Fi02in both arms | 1 hour | 
| Comparison of the Report Sp02/Fi02 in both arms | Assessment of Report Sp02/Fi02in both arms | 12 hours | 
| Comparison of the Report Sp02/Fi02 in both arms | Assessment of Report Sp02/Fi02in both arms | 24 hours | 
| number of participants with skin lesions in both arms | number of participants with skin lesions in both arms and classification of the lesions with the National Pressure Ulcer Advisory Panel (NPUAP) | 1 hour | 
| number of participants with skin lesions in both arms | number of participants with skin lesions in both arms and classification of the lesions with the National Pressure Ulcer Advisory Panel (NPUAP) | 12 hours | 
| number of participants with skin lesions in both arms | number of participants with skin lesions in both arms and classification of the lesions with the National Pressure Ulcer Advisory Panel (NPUAP) | 24 hours | 
| number of participants with Discomfort in both arms | Assessment of the discomfort in both arms with the score of EDIN | 1 hour | 
| number of participants with Discomfort in both arms | Assessment of the discomfort in both arms with the score of EDIN | 12 hours | 
| number of participants with Discomfort in both arms | Assessment of the discomfort in both arms with the score of EDIN | 24 hours |