Performance and Safety of the PRICO Closed-Loop Oxygen Saturation Targeting System in Neonates: Pragmatic Multicentre Cross-over Study (tarox Study)

Objective This 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 (FiO(2)). Design Multicentre randomised cross-over study. Setting Five neonatal intensive care units experienced with automated control of FiO(2) and the fabian ventilator. Patients 39 infants: median gestational age of 27 weeks (IQR: 26-30), postnatal age 7 days (IQR: 2-17), weight 1120 g (IQR: 915-1588), FiO(2) 0.32 (IQR: 0.22-0.43) receiving both non-invasive (27) and invasive (12) respiratory support. Intervention Randomised sequential 24-hour periods of automated and manual FiO(2) control. Main outcome measures Proportion (%) of time in normoxaemia (90%-95% with FiO(2)>0.21 and 90%-100% when FiO(2)=0.21) was the primary endpoint. Secondary endpoints were severe hypoxaemia (<80%) and severe hyperoxaemia (>98% with FiO(2)>0.21) and prevalence of episodes >= 60 s at these two SpO(2) extremes. Results During automated control, subjects spent more time in normoxaemia (74%+/- 22% vs 51%+/- 22%, p<0.001) with less time above and below (<90% (9%+/- 8% vs 12%+/- 11%, p<0.001) and >95% with FiO(2)>0.21 (16%+/- 19% vs 35%+/- 24%) p<0.001). They spent less time in severe hyperoxaemia (1% (0%-3.5%) vs 5% (1%-10%), p<0.001) but exposure to severe hypoxaemia was low in both arms and not different. The differences in prolonged episodes of SpO(2) were consistent with the times at extremes. Conclusions This study demonstrates the ability of the PRICO automated oxygen control algorithm to improve the maintenance of SpO(2) in normoxaemia and to avoid hyperoxaemia without increasing hypoxaemia.