Last updated on April 2020

Automation of Oxygen Delivery in Spontaneous Ventilation (FreeO2) in Infants


Brief description of study

The objective of this study is to demonstrate a decrease in the duration of hospitalization in case of first oxygen-dependent bronchiolitis thanks to the use of the FreeO2 system in infants less than 1 year old. The advantage of using FreeO2 system would be to shorten the duration of hospitalization.

FreeO2Bronchio is a multicenter, prospective, randomized, open-label study.

Detailed Study Description

This is a multi-center, randomized, open-controlled, multicentre trial. Patients will be included after a compendium of informed and express consent from both parents. They will then be randomized either in the "FreeO2" arm or in the "manual" arm for Oxygen therapy with manual flow adjustment. The SpO2 will be recorded continuously in both arms of the study using the FREEO2 device throughout the duration of hospitalization; In the arm "FreeO2 " The device will record the data continuously and allow the automation of oxygen administration - in the arm "Manual", the device is only used in the monitoring mode of SpO2 and heart rate.

Clinical Study Identifier: NCT03614507

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