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 (FiO2). DESIGN: Multicentre randomised cross-over study. SETTING: Five neonatal intensive care units experienced with automated control of FiO2 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), FiO2 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 FiO2 control. MAIN OUTCOME MEASURES: Proportion (%) 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 (<80%) and severe hyperoxaemia (>98% with FiO2>0.21) and prevalence of episodes ≥60 s at these two SpO2 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 FiO2>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 SpO2 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 SpO2 in normoxaemia and to avoid hyperoxaemia without increasing hypoxaemia.

2 Department of Neonatology Poznan University of Medical Sciences Poznan Poland

Amsterdam Reproduction and Development Research Institute UMC Amsterdam The Netherlands

Departent of Neonatology Emma Children's Hospital UMC University of Amsterdam Amsterdam The Netherlands

Department of Neonatology Centre for Postgraduate Medical Education Warsaw Poland

Department of Neonatology Pomeranian Medical University in Szczecin Szczecin Poland

Department of Neonatology Ujastek Medical Cetner Krakow Poland

Department of Neontology Ujastek Medical Center Krakow Poland

Department of Obstetrics and Perinatology National Medical Institute Warsaw Poland

Faculty Biomedical Engineering Czech Technical University Prague Kladno Czech Republic

Neonatal Biophysical Monitoring and Cardiopulmonary Therapies Research Unit Poznan University of Medical Sciences Poznan Poland

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