Comparison Between 2l vs 3l in HFNC 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 2 different flow with High flow nasal canula (HFNC: 2l/kg/min) versus (HFNC: 2l/kg/min) in the initial management of bronchiolitis in infants. Design: 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:HFNC 2l/min/kg or HFNC 3l/min/kg 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 required to achieve an oxygen saturation between 94 and 97%, transcutaneous PCO2 (correlated to an initial gas analysis), Report SpO2 / FiO2 Statistic: Intention to treat Analysis. Expected number of patients: 135 per arm: 270 children.

Official Title
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Comparison Between 2l/Min/kg vs 3l/Min/kg in High Flow Nasal Cannula (HFNC) During the Initial Management of Severe Bronchiolitis in Infants

Conditions
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Bronchiolitis

Intervention / Treatment
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* Device: treatment by 2l/min/kg in High Flow Nasal cannula (HFNC)
* Device: treatment by 3l/min/kg in High Flow Nasal cannula (HFNC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age < 6 months bronchiolitis mWCAS > or =3 hospitalisation: PICU signed consent form by parents Exclusion Criteria: Intubated patient Neurological or cardiac disease

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: treatment by 2l/min/kg in HFNC<br>treatment by 2l/min/kg in High Flow Nasal cannula (HFNC) during the initial management of severe bronchiolitis in infants (0-6 months years old) | Device: treatment by 2l/min/kg in High Flow Nasal cannula (HFNC)<br> <br> |
| Experimental: treatment by 3l/min/kg in HFNC<br>treatment by 3l/min/kg in High Flow Nasal cannula (HFNC) during the initial management of severe bronchiolitis in infants (0-6 months years old) | Device: treatment by 3l/min/kg in High Flow Nasal cannula (HFNC)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of failure in both arms | 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. | up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of heart rate in both arm |  | up to 24 hours | 
| Assessment of the discomfort in both arms with the score of EDIN |  | up to 24 hours | 
| assessment of the fraction of inspired oxygen (FiO2) in both arms | FiO2 required to achieve an oxygen saturation between 94 and 97% | up to 24 hours | 
| number of participants with an aggravation of the clinical score for respiratory distress arms (mWCAS) |  | up to 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bronchiolitis, High flow nasal canula