OXYNOV discontinues loan of FREEO2 devices

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.

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)

The technology used does not allow blinding.