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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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.


Detailed Summary:
Sponsor: University Hospital, Montpellier

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • assessment of heart rate in both arm [ Time Frame: up to 24 hours ]
  • Assessment of the discomfort in both arms with the score of EDIN [ Time Frame: up to 24 hours ]
  • assessment of the fraction of inspired oxygen (FiO2) in both arms [ Time Frame: up to 24 hours ]
    FiO2 required to achieve an oxygen saturation between 94 and 97%
  • number of participants with an aggravation of the clinical score for respiratory distress arms (mWCAS) [ Time Frame: up to 24 hours ]


Original Secondary Outcome: Same as current

Information By: University Hospital, Montpellier

Dates:
Date Received: June 27, 2016
Date Started: October 2016
Date Completion: October 2017
Last Updated: July 1, 2016
Last Verified: July 2016