Prolonged use of closed-loop inspired oxygen support in preterm infants: a randomised controlled trial

Objective This randomised study in preterm infants on non-invasive respiratory support investigated the effectiveness of automated oxygen control (A-FiO(2)) in keeping the oxygen saturation (SpO(2)) within a target range (TR) during a 28-day period compared with manual titration (M-FiO(2)).Design A single-centre randomised control trial.Setting A level III neonatal intensive care unit.Patients Preterm infants (<28 weeks' gestation) on non-invasive respiratory support.Interventions A-FiO(2) versus M-FiO(2) control.Methods Main outcomes were the proportion of time spent and median area of episodes in the TR, hyperoxaemia, hypoxaemia and the trend over 28 days using a linear random intercept model.Results 23 preterm infants (median gestation 25.7 weeks; birth weight 820 g) were randomised. Compared with M-FiO(2), the time spent within TR was higher in the A-FiO(2) group (68.7% vs 48.0%, p<0.001). Infants in the A-FiO(2) group spent less time in hyperoxaemia (13.8% vs 37.7%, p<0.001), but no difference was found in hypoxaemia. The time-based analyses showed that the A-FiO2 efficacy may differ over time, especially for hypoxaemia. Compared with the M-FiO2 group, the A-FiO(2) group had a larger intercept but with an inversed slope for the daily median area below the TR (intercept 70.1 vs 36.3; estimate/day -0.70 vs 0.69, p<0.001).Conclusion A-FiO(2) control was superior to manual control in keeping preterm infants on non-invasive respiratory support in a prespecified TR over a period of 28 days. This improvement may come at the expense of increased time below the TR in the first days after initiating A-FiO(2 )control.