Automation Oxygen Flow Titration in Spontaneously Breathing Infants

Status Terminated

Clinical Trial Summary

The objective of this study is to assess the efficacy of the FreeO2 device in shortening the hospital length of stay during a first episode of hypoxemic bronchiolitis in infants less than 1 year of age. FreeO2Bronchio study is a multicenter, prospective, controlled, randomized, open-label study.

Clinical Trial Description

This is a controlled, randomized, open-label, multicentre trial. Patients will be included after written informed consent will be obtained from the patients' parents or legally authorized representatives. Patients will be randomized either in the "FreeO2" group for automatic oxygen flow titration or in the "manual" group for Oxygen therapy with manual flow titration. The SpO2 will be recorded continuously in both groups of the study using the FreeO2 device throughout the duration of hospitalization; In the group "FreeO2 ", the device will record the data continuously and allow the automation of oxygen titration - in the group "Manual", the device will only be used to monitor SpO2 and heart rate. ;

Study Design

Related Conditions & MeSH terms

Bronchiolitis

Clinical Trial Details

NCT number	NCT03614507
Study type	Interventional
Source	University Hospital, Brest
Contact
Status	Terminated
Phase	N/A
Start date	October 9, 2018
Completion date	July 5, 2023

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