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Automation of Oxygen Delivery in Spontaneous Ventilation (FreeO2) in Infants (FreeO2Bronchio)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03614507
Recruitment Status : Recruiting
First Posted : August 3, 2018
Last Update Posted : March 23, 2020
Information provided by (Responsible Party):
University Hospital, Brest

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Bronchiolitis Device: FreeO2 (modèle FO2-220-00) automatic adjustment Device: FreeO2 (modèle FO2-220-00) manual adjustment Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a multicenter, prospective, randomized, open-label study. Patients will then be randomized to either the "FreeO2 Arm" or the "Manual Arm" for Oxygen Therapy with Manual Flow Adaptation.
Masking: None (Open Label)
Masking Description: The technology used does not allow blinding.
Primary Purpose: Treatment
Official Title: Automation of Oxygen Delivery in Spontaneous Ventilation (FreeO2) in Infants Under One Year Old With Bronchiolitis
Actual Study Start Date : October 9, 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Experimental: FreeO2 Arm
Automatic adjustment of oxygen
Device: FreeO2 (modèle FO2-220-00) automatic adjustment
Automatic adjustment of oxygen through the "Free O2" device and in mode medical data collecting (SpO2)

Active Comparator: Manual Arm
Manual adjustment of oxygen
Device: FreeO2 (modèle FO2-220-00) manual adjustment
Manual adjustment of oxygen by the nurse or medical staff. The "Free O2" device will only be used in mode medical data collecting (SpO2)

Primary Outcome Measures :
  1. Duration of hospitalization in hours since the entrance to the emergency room. [ Time Frame: 30 days max ]
    The length of hospital stay in hours since arrival at the emergency room will be compared between the two groups.

Secondary Outcome Measures :
  1. Re-hospitalization within 7 days and 30 days [ Time Frame: 30 days max ]
  2. Frequency of use of ventilation (invasive or noninvasive ) [ Time Frame: 30 days max ]
  3. Transfer to continuous care units or resuscitation within 3 days [ Time Frame: 30 days max ]
  4. Time spent in enteral nutrition on gastric tube in hours [ Time Frame: 30 days max ]
  5. Time spent under intravenous hydration in hours [ Time Frame: 30 days max ]
  6. Reports of AEs [ Time Frame: 30 days max ]
  7. Time spent in a area of severe desaturation (SpO2 <92%) and a hyperoxia area (SpO2> 98%). [ Time Frame: 30 days max ]
  8. Frequency of use of high-speed glasses (Optiflow) [ Time Frame: 30 days max ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   1 Month to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Children older than 1 month and less than 1 year of age who have a first episode of bronchiolitis and require oxygen therapy
  • Informed consent of parents
  • Affiliation to the social security system

Exclusion Criteria:

  • Need for an oxygen flow rate higher than 3 L / min to maintain SpO2 greater than 92%
  • Patient with a severe form according to 2019 HAS criteria and needing to maintain SpO2 greater than 94%
  • Criteria of gravity justifying from the start another technique of respiratory assistance:

    • 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 if blood gas sample
  • Need for urgent surgery
  • Contraindication to the FreeO2 device as described in the user manual
  • Absence of informed consent of parents
  • Birth term less than 36 SA
  • Severe Co-morbidity (cystic fibrosis, immune deficiency, complex heart disease, neuromuscular illness)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03614507

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Contact: Jean-Michel ROUE, Dr 02 98 22 36 67 ext +33

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Angers, University Hospital Recruiting
Angers, France, 49993
Contact: Françoise TROUSSIER, Dr   
Brest, University Hospital Recruiting
Brest, France, 29609
Contact: Jean-Michel ROUE, Dr   
Contact: Pierrick CROS, Dr   
La-Roche-Sur-Yon, Departmental Hospital Center Recruiting
La Roche-sur-Yon, France, 85000
Contact: Xavier MICAELLI, Dr   
Limoges, University Hospital Recruiting
Limoges, France, 87000
Contact: Rachel FROGET, Dr   
Marseille, University Hospital Recruiting
Marseille, France, 13285
Contact: Ania CARSIN, Dr   
La Timone, University Hospital Recruiting
Marseille, France, 13385
Contact: Jean-Christophe DUBUS, Dr   
Nantes, University Hospital Recruiting
Nantes, France, 44093
Contact: Tiphaine BIHOUEE, Dr   
Lenval, University Hospital Recruiting
Nice, France, 06200
Contact: Lisa GIOVANNINI-CHAMI, Dr   
Rennes, university Hospital Active, not recruiting
Rennes, France, 35000
Sponsors and Collaborators
University Hospital, Brest
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Principal Investigator: Jean-Michel ROUE, Dr CHU de Brest

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Responsible Party: University Hospital, Brest Identifier: NCT03614507    
Other Study ID Numbers: FreeO2Bronchio (29BRC18.0091)
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: March 23, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Brest:
oxygen dependent
Infant Between 1 Month and 12 Months Old
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections