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Clinical Trial Summary

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


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02457013
Study type Interventional
Source University Hospital, Montpellier
Contact Christophe MILESI, Doctor
Phone 0033467336609
Email c-milesi@chu-montpellier.fr
Status Recruiting
Phase N/A
Start date October 2014
Completion date November 2016

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