Comparison Between 2l/Min/kg vs 3l/Min/kg in High Flow Nasal Cannula (HFNC) During the Initial Management of Severe Bronchiolitis in Infants
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 300
- Locations
- 2
- Primary Endpoint
- Proportion of failure in both arms
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 0 Hours to 6 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age < 6 months
- •bronchiolitis
- •mWCAS > or =3
- •hospitalisation: PICU
- •signed consent form by parents
Exclusion Criteria
- •Intubated patient
- •Neurological or cardiac disease
Outcomes
Primary Outcomes
Proportion of failure in both arms
Time Frame: up to 24 hours
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 of the discomfort in both arms with the score of EDIN(up to 24 hours)
- assessment of heart rate in both arm(up to 24 hours)
- number of participants with an aggravation of the clinical score for respiratory distress arms (mWCAS)(up to 24 hours)
- assessment of the fraction of inspired oxygen (FiO2) in both arms(up to 24 hours)