Bronchiolitis Clinical Trial
Official title:
Comparison Between 2l/Min/kg vs 3l/Min/kg in High Flow Nasal Cannula (HFNC) During the Initial Management of Severe Bronchiolitis in Infants
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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