Introduction: When children require supplemental oxygen due to acute hypoxemic respiratory distress (AHRD), manual control of the oxygen flow is often difficult and time-consuming, and carries the risk of unrecognized hypoxia and hyperoxia. To date, no automatic oxygen titration system has been developed and evaluated in spontaneously breathing children. Methods: Children between 1 month and 15 years of age receiving supplemental oxygen due to AHRD were recruited within 24 hours following the onset of the O 2 administration in a French University Department of Paediatrics. Patients were randomized to receive either automated oxygen administration using the FreeO2 device, or conventional manual oxygen administration over a maximum period of 6 hours. Stratification was performed to classify the patients into two age groups: 1 month to 2 years of age and 2 to 15 years of age. The primary outcome was % time spent within the SpO 2 target range (92%-98%). Results: 60 patients (30 infants, 30 children) were randomized and 55 could be analyzed for the primary outcome (28 automated, 27 manual). The automated O 2 delivery using the FreeO2 device significantly increased the time spent within the predefined SpO 2 range (94.6% ± 6% vs 76.3% ± 22%, difference [95% confidence interval {CI}] 18.4 [10.1; 26.7]) with less time spent with hypoxemia (1% ± 1.1% vs 15.1% ± 21.8%, difference [95% CI] −14.4 [−22.2; −6.7]). This difference was greater among (2-15 years of age) children, compared to (1 month-2 years of age) infants. Conclusions: The present randomized controlled pilot study indicates that the tested automated closed-loop O 2 titration technology was safe and yielded improved oxygen parameters among spontaneously breathing children. Based on our pilot data, a full randomized controlled trial will be required to verify the potential clinical benefits.

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