Performance and safety of the PRICO closed-loop oxygen saturation targeting system in neonates: pragmatic multicentre cross-over study (TarOx Study)

ObjectiveThis study aims to evaluate the performance of the fabian-Predictive-Intelligent-Control-of-Oxygenation (PRICO) system for automated control of the fraction of inspired oxygen (FiO2).DesignMulticentre randomised cross-over study.SettingFive neonatal intensive care units experienced with automated control of FiO2 and the fabian ventilator.Patients39 infants: median gestational age of 27 weeks (IQR: 26–30), postnatal age 7 days (IQR: 2–17), weight 1120 g (IQR: 915–1588), FiO2 0.32 (IQR: 0.22–0.43) receiving both non-invasive (27) and invasive (12) respiratory support.InterventionRandomised sequential 24-hour periods of automated and manual FiO2 control.Main outcome measuresProportion (%) of time in normoxaemia (90%–95% with FiO2>0.21 and 90%–100% when FiO2=0.21) was the primary endpoint. Secondary endpoints were severe hypoxaemia (98% with FiO2>0.21) and prevalence of episodes ≥60 s at these two SpO2 extremes.ResultsDuring automated control, subjects spent more time in normoxaemia (74%±22% vs 51%±22%, p