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Automatic oxygen control for reducing extremes of oxygen saturation: a randomised controlled trial


Objective The objective of this study was to evaluate the efficacy of the automatic oxygen control (A-Fio2) in reducing the percentage of time spent in severe hypoxaemia (Spo2 <80%) in preterm infants for the time period on invasive ventilation and/or nasal continuous positive airway pressure (NCPAP) delivered by AVEA ventilator.

Design A parallel arm randomised controlled trial.

Setting A level-III neonatal intensive care unit.

Patients Preterm infants (<33 weeks birth gestation) who received invasive ventilation or NCPAP in the first 72 hours of age.

Interventions A-Fio2 vs manual (M-Fio2) oxygen control.

Outcomes The primary outcome of the study was percentage of time spent in severe hypoxaemia (Spo2 <80%).

Results 44 infants were randomised to either A-Fio2 or M-Fio2 arm and continued in the study for the period of respiratory support (invasive ventilation and/or NCPAP). The total number of study days in A-Fio2 and M-Fio2 arm were 194 and 204 days, respectively. The percentage of time spent in Spo2 <80% was significantly lower with A-Fio2 compared with M-Fio2 (median of 0.1% (IQR: 0.07–0.7) vs 0.6% (0.2–2); p=0.03). The number of prolonged episodes (>60 s) of Spo2 <80% per day was also significantly lower in A-Fio2 (0.3 (0.0–2) vs 2 (0.6–6); p=0.02).

Conclusion A-Fio2 was associated with statistically significant reduction in the percentage of time spent in severe hypoxaemia when compared with M-Fio2 in preterm infants receiving respiratory support.

Trial registration number NCT04223258.

  • Neonatology
  • Intensive Care Units, Neonatal

Data availability statement

All data relevant to the study are included in the article or uploaded as supplementary information.

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