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Clinical Trial

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

NCT: NCT02824744 · COMPLETED

NCT IDNCT02824744
StatusCOMPLETED
Start Date2016-11-02
Completion2018-03
SponsorUniversity Hospital, Montpellier (OTHER)
First posted
Last updated

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.

Frequently Asked Questions

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

Comparison Between 2l vs 3l in HFNC During the Initial Management of Severe Bronchiolitis in Infants is a clinical trial registered under NCT02824744. Current status: COMPLETED.

What is the status of NCT02824744?

The current status of NCT02824744 (Comparison Between 2l vs 3l in HFNC During the Initial Management of Severe Bronchiolitis in Infants) is: COMPLETED.

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

Comparison Between 2l vs 3l in HFNC During the Initial Management of Severe Bronchiolitis in Infants started on 2016-11-02.

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Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.