1. 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. 2. Design: non-inferiority study, prospective, controlled, randomized, multi-center. 3. 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. 4. 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 5. Statistic: Intention to treat Analysis. Expected number of patients: 71 per arm: 142 children. 6. Study Schedule: October 2014-April 2016
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
142
University Hospital of Montpellier
Montpellier, France
RECRUITINGProportion 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.
Time frame: 24 hours
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
Time frame: 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
Time frame: 12hours
number of participants with an increase of the clinical score for respiratory distress arms
Assessment of Report Sp02/Fi02in both arms
Time frame: 1 hour
Comparison of the Report Sp02/Fi02 in both arms
Assessment of Report Sp02/Fi02in both arms
Time frame: 1 hour
Comparison of the Report Sp02/Fi02 in both arms
Assessment of Report Sp02/Fi02in both arms
Time frame: 12 hours
Comparison of the Report Sp02/Fi02 in both arms
Assessment of Report Sp02/Fi02in both arms
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 24 hours
number of participants with Discomfort in both arms
Assessment of the discomfort in both arms with the score of EDIN
Time frame: 1 hour
number of participants with Discomfort in both arms
Assessment of the discomfort in both arms with the score of EDIN
Time frame: 12 hours
number of participants with Discomfort in both arms
Assessment of the discomfort in both arms with the score of EDIN
Time frame: 24 hours
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