NCT02824744

Comparison Between 2l vs 3l in HFNC During the Initial Management of Severe Bronchiolitis in Infants

Comparison Between 2l/Min/kg vs 3l/Min/kg in High Flow Nasal Cannula (HFNC) During the Initial Management of Severe Bronchiolitis in Infants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 0 Hours – 6 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Bronchiolitis

Interventions

Type	Name	Description
DEVICE	treatment by 2l/min/kg in High Flow Nasal cannula (HFNC)
DEVICE	treatment by 3l/min/kg in High Flow Nasal cannula (HFNC)

Timeline

• Start date: 2016-11-02
• Primary completion: 2017-03-17
• Completion: 2018-03-01
• First posted: 2016-07-07
• Last updated: 2024-05-30

Locations

1 site across 1 country: France