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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
105
Automatic adjustment of oxygen flow titration through the FreeO2 device. The monitor allows continuous monitoring and recording of SpO2 and Heart rate
Manual oxygen flow titration performed by the healthcare provider in charge of the patient (nurse, physician). For this group, the FreeO2 device will only monitor and record SpO2 and heart rate.
La-Roche-Sur-Yon, Departmental Hospital Center
La Roche-sur-Yon, France, France
Limoges, University Hospital
Limoges, France, France
Lenval, University Hospital
Nice, France, France
Angers, University Hospital
Angers, France
Length of hospital stay in hours since the admission to the emergency room.
The length of hospital stay in hours since admission in the emergency room will be compared between the two groups.
Time frame: 30 days max
Number of patients readmited to hospital within 7 days and 30 days following discharge
Time frame: 30 days max
Number of patients needing assisted ventilation (invasive or noninvasive )
Time frame: 30 days max
Number of patient admitted to the intensive care unit within 3 days following the hospital admission
Time frame: 30 days max
Duration of enteral feeding (hours)
Time frame: 30 days max
Duration of intravenous hydration (hours)
Time frame: 30 days max
Number of reported Adverse Events
Time frame: 30 days max
Time spent in the a area of severe desaturation (SpO2 <92%) and of hyperoxia area (SpO2> 98%).
Time frame: 30 days max
Number of patients needing Heated Humidified High Flow Nasal Cannula (HFNNC)
Time frame: 30 days max
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Brest, University Hospital
Brest, France
CHI Créteil
Créteil, France
GHBS Lorient
Lorient, France
Marseille, University Hospital
Marseille, France
Nantes, University Hospital
Nantes, France
Rennes, university Hospital
Rennes, France