Interest of High Flow Nasal Cannula (HFNC) Versus Non Invasive Ventilation During the Initial Management of Severe Bronchiolitis in Infants
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bronchiolitis
- Sponsor
- University Hospital, Montpellier
- Enrollment
- 142
- Locations
- 1
- Primary Endpoint
- Proportion of failure
- Last Updated
- 10 years ago
Overview
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.
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Design: non-inferiority study, prospective, controlled, randomized, multi-center.
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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.
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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
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Statistic: Intention to treat Analysis. Expected number of patients: 71 per arm: 142 children.
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Study Schedule: October 2014-April 2016
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Proportion of failure
Time Frame: 24 hours
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.
Secondary Outcomes
- number of participants with an aggravation of the clinical score for respiratory distress arms(12hours)
- Comparison of the Report Sp02/Fi02 in both arms(24 hours)
- number of participants with skin lesions in both arms(24 hours)
- number of participants with an increase of the clinical score for respiratory distress arms(1 hour)
- number of participants with Discomfort in both arms(24 hours)