Randomised cross-over study of automated oxygen control for preterm infants receiving nasal high flow

To evaluate a prototype automated controller (IntellO₂) of the inspired fraction of oxygen (FiO₂) in maintaining a target range of oxygen saturation (SpO₂) in preterm babies receiving nasal high flow (HF) via the Vapotherm Precision Flow.

Prospective two-centre order-randomised cross-over study.

Neonatal intensive care units.

Preterm infants receiving HF with FiO₂ ≥25%.

Automated versus manual control of FiO₂ to maintain a target SpO₂ range of 90%-95% (or 90%-100% if FiO₂=21%).

The primary outcome measure was per cent of time spent within target SpO₂ range. Secondary outcomes included the overall proportion and durations of SpO₂ within specified hyperoxic and hypoxic ranges and the number of in-range episodes per hour.

Data were analysed from 30 preterm infants with median (IQR) gestation at birth of 26 (24-27) weeks, study age of 29 (18-53) days and study weight 1080 (959-1443) g. The target SpO₂ range was achieved 80% of the time on automated (IntellO₂) control (IQR 70%-87%) compared with 49% under manual control (IQR 40%-57%; p<0.0001). There were fewer episodes of SpO₂ below 80% lasting at least 60 s under automated control (0 (IQR 0-1.25)) compared with manual control (5 (IQR 2.75-14)). There were no differences in the number of episodes per hour of SpO₂ above 98% (4.5 (IQR 1.8-8.5) vs 5.5 (IQR 1.9-14); p=0.572) between the study arms.

The IntellO₂ automated oxygen controller maintained patients in the target SpO₂ range significantly better than manual adjustments in preterm babies receiving HF.

NCT02074774.