Automation Oxygen Flow Titration in Spontaneously Breathing Infants (FreeO2Bronchio)

December 13, 2024 updated by: University Hospital, Brest

Automation Oxygen Flow Titration in Spontaneously Breathing Infants Less Than One Year of Age During a First Episode of Bronchiolitis

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49993
        • Angers, University Hospital
      • Brest, France, 29609
        • Brest, University Hospital
      • Créteil, France, 94000
        • CHI Créteil
      • La Roche-sur-Yon, France, 85000
        • La-Roche-Sur-Yon, Departmental Hospital Center
      • Limoges, France, 87000
        • Limoges, University Hospital
      • Lorient, France, 56322
        • GHBS Lorient
      • Marseille, France, 13285
        • Marseille, University Hospital
      • Nantes, France, 44093
        • Nantes, University Hospital
      • Nice, France, 06200
        • Lenval, University Hospital
      • Rennes, France, 35000
        • Rennes, University hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 1 year (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Infants from 1 month of age and less than 1 year of age who present a first episode of bronchiolitis and require oxygen therapy
  • Informed consent of parents (written informed consent will be obtained from the patients' parents or legally authorized representatives)
  • Affiliation to the French social security system

Exclusion Criteria:

  • Need for oxygen flow higher than 3 L / min to maintain SpO2 greater than 92%
  • Patient with severity criteria according to the 2019 French National Authority for Health (HAS) guidelines and for whom it's indicated to maintain SpO2 above 94%

  • Criteria of severity justifying from the start another technique of assisted ventilation:

    • Polypnea: respiratory rate (FR)> 80 c / min.
    • Consciousness with glasgow score (GSC) <or = 12. Hemodynamic instability (mean arterial pressure (MAP) <- 2 SD for age or use of vasopressors).
    • Cardiac or respiratory arrest.
    • PCO2> 55 mm Hg and pH <7.20 when blood gas are performed
  • Need for urgent surgery
  • Contraindication to the FreeO2 device as described in the user manual
  • Lack of informed consent from parents
  • Premature birth with a gestational age at birth under 36 weeks
  • Severe co-morbidities (cystic fibrosis, immune deficiency, congenital heart disease, neuromuscular illness)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FreeO2 group
Automatic oxygen flow titration
Device: FreeO2 (modèle FO2-220-00) automatic oxygen flow titration
Automatic adjustment of oxygen flow titration through the FreeO2 device. The monitor allows continuous monitoring and recording of SpO2 and Heart rate
Active Comparator: Manual group
Manual oxygen flow titration
Device: FreeO2 (modèle FO2-220-00) manual oxygen flow titration
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay in hours since the admission to the emergency room.
Time Frame: 30 days max
The length of hospital stay in hours since admission in the emergency room will be compared between the two groups.
30 days max

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients readmited to hospital within 7 days and 30 days following discharge
Time Frame: 30 days max
30 days max
Number of patients needing assisted ventilation (invasive or noninvasive )
Time Frame: 30 days max
30 days max
Number of patient admitted to the intensive care unit within 3 days following the hospital admission
Time Frame: 30 days max
30 days max
Duration of enteral feeding (hours)
Time Frame: 30 days max
30 days max
Duration of intravenous hydration (hours)
Time Frame: 30 days max
30 days max
Number of reported Adverse Events
Time Frame: 30 days max
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
30 days max
Number of patients needing Heated Humidified High Flow Nasal Cannula (HFNNC)
Time Frame: 30 days max
30 days max

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Investigators

  • Principal Investigator: Jean-Michel ROUE, Dr, CHU de Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2018

Primary Completion (Actual)

July 5, 2023

Study Completion (Actual)

July 5, 2023

Study Registration Dates

First Submitted

July 30, 2018

First Submitted That Met QC Criteria

July 30, 2018

First Posted (Actual)

August 3, 2018

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 13, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FreeO2Bronchio (29BRC18.0091)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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