This single-center randomized controlled trial enrolled 69 preterm infants with a median gestational age of 27.0 weeks, studied at a corrected postmenstrual age of 27.6 weeks, in a tertiary neonatal unit in London, UK. The intervention was closed-loop automated oxygen control (CLAC), compared to manual oxygen control.
The primary outcome was duration of mechanical ventilation. The CLAC group had a median duration of 11 days (range 1-57) versus 40 days (range 3-134) in the manual group (p=0.027). For supplemental oxygen, the CLAC group had a median of 33 days (range 0-100) versus 47 days (range 3-335) (p=0.031). The incidence of bronchopulmonary dysplasia at 36 weeks was 55% in the CLAC group versus 83.9% (p=0.015). Requirement for home oxygen was 26.5% versus 51.4% (p=0.016).
Time spent in the target oxygen range (91%-95%) increased with CLAC (p<0.001), while time in hypoxaemia (SpO2<85%) and hyperoxaemia (SpO2>95%) were both reduced (p<0.001 for both). Absolute numbers for these time outcomes were not reported.
Safety data, including adverse events, serious adverse events, discontinuations, and tolerability, were not reported. Key limitations include the single-center design and the need for replication in larger multicentre studies before changing routine practice. The association reported does not imply causation. While CLAC use was associated with improved oxygen saturation targets and clinical outcomes, certainty is limited as this is a single RCT.
View Original 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 (SpO)<85%) and hyperoxaemia (SpO>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.