Closed-loop automated oxygen control in preterm ventilated infants: a randomised controlled trial

Clinical Snapshot

Key Findings

• P Value: p=0.027 for primary outcome

• Effect Size: Median reduction of 29 days in mechanical ventilation duration

• Primary Outcome: Duration of mechanical ventilation: CLAC 11 days vs manual control 40 days

• Nnt Or Sensitivity: NNT approximately 3.5 to prevent one case of BPD (based on 28.9% absolute risk reduction)

• Confidence Interval: Not reported

Clinical Application

Requires automated oxygen control technology and staff training, feasible in well-resourced tertiary centres Relevant to Australian level 6 NICUs. Technology would need TGA approval. Potential for significant healthcare cost savings through reduced ventilation duration and BPD rates Extremely preterm infants requiring mechanical ventilation in tertiary neonatal intensive care units

Abstract

OBJECTIVE: To compare the duration of mechanical ventilation between preterm infants receiving closed-loop automated oxygen control (CLAC) or manual oxygen control. DESIGN: Randomised controlled trial. SETTING: Tertiary neonatal unit in London, UK. PATIENTS: Infants (n=69) with a median (IQR) gestational age of 27.0 (25.6-29.0) weeks studied at a corrected postmenstrual age of 27.6 (25.9-29.1) weeks. INTERVENTIONS: Infants were randomised to CLAC or manual oxygen control within 48 hours of initiation of mechanical ventilation if less than 7 days of age until successful extubation. MAIN OUTCOME MEASURES: Duration of mechanical ventilation. RESULTS: The CLAC infants (n=34) compared with those who received manual control had a shorter duration of mechanical ventilation (median (range): 11 (1-57) vs 40 (3-134) days, p=0.027), a shorter duration of supplemental oxygen (median (range): 33 (0-100) vs 47 (3-335) days, p=0.031), a lower incidence of bronchopulmonary dysplasia (BPD) at 36 weeks postmenstrual age (55% vs 83.9%, p=0.015) and fewer required home oxygen (26.5% vs 51.4%, p=0.016). In the CLAC infants, the time spent in the target oxygen range (91%-95%) was increased (p<0.001) and the times spent in hypoxaemia (peripheral oxygen saturation level (SpO2)<85%) and hyperoxaemia (SpO2>95%) were reduced (p<0.001). CONCLUSIONS: Use of CLAC in preterm, ventilated infants was associated with improved achievement of oxygen saturation targets, shorter durations of mechanical ventilation and supplemental oxygen treatment and a lower incidence of BPD. These results need to be replicated in larger multicentre studies before any change in routine practice could be recommended. TRIAL REGISTRATION NUMBER: NCT05030337.

References

1. 1.Kaltsogianni, O., Dassios, T., Jenkinson, A., Jeffreys, E., Ikeda, K., Sugino, M., & Greenough, A. (2026). Closed-loop automated oxygen control in preterm ventilated infants: a randomised controlled trial. Archives of Disease in Childhood. Fetal and Neonatal Edition. https://doi.org/10.1136/archdischild-2025-329022