Comparison of two automated oxygen control algorithms in mechanically ventilated neonates: an open label, randomised, crossover trial.

Objective

To compare rule-based non-fuzzy algorithm (Predictive Intelligent Control of Oxygenation (PRICO)) with adaptive algorithm (Closed-loop Inspired Oxygen (CLiO2)) for automated oxygen control in mechanically ventilated neonates.

Design

Open label, randomised, crossover trial.

Setting

Level III neonatal intensive care unit. PATIENTS Neonates ≤44 weeks post-menstrual age receiving invasive or non-invasive ventilation and fraction of inspired oxygen (FiO₂) ≥25%.

Interventions

Participants randomised to one of two sequences of auto-FiO2 (CLiO2 then PRICO or PRICO then CLiO2). Each algorithm in the sequence was applied for 24 hours before crossing over to an alternate algorithm. Target saturation was 91-95%. Masimo pulse-oximeters were used for saturation measurement. MAIN OUTCOME Primary outcome was time-weighted proportion of time spent within target saturation range. Secondary outcomes were time spent below and above target saturation range.

Results

32 neonates were enrolled; 29 completed both intervention periods and contributed to paired data. Mean time-weighted proportion within target range was 76% in the CLiO2 group compared with 62% in PRICO (mean within-participant difference (PRICO-CLiO2) -14 percentage points, 95% CI -24 to -4; paired t-test p=0.01). A mixed-effects model accounting for period gave an 18 percentage points difference (82% vs 64%; treatment effect -0.92 on the logit scale, 95% CI -1.51 to -0.33, p=0.004). Time-weighted proportion spent above target range was lower with CLiO2 (15% vs 30%). Time spent below target range was comparable between groups. No significant period or carryover effect was observed.

Conclusions

In mechanically ventilated neonates, adaptive CLiO2 algorithm did maintain the oxygen saturation within target range for a greater proportion of time and reduced hyperoxic exposure compared with the rule-based PRICO algorithm. TRIAL REGISTRATION NUMBER CTRI/2025/05/087301.