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Prolonged use of closed-loop inspired oxygen support in preterm infants: a randomised controlled trial

Abstract

Objective This randomised study in preterm infants on non-invasive respiratory support investigated the effectiveness of automated oxygen control (A-FiO2) in keeping the oxygen saturation (SpO2) within a target range (TR) during a 28-day period compared with manual titration (M-FiO2).

Design A single-centre randomised control trial.

Setting A level III neonatal intensive care unit.

Patients Preterm infants (<28 weeks’ gestation) on non-invasive respiratory support.

Interventions A-FiO2 versus M-FiO2 control.

Methods Main outcomes were the proportion of time spent and median area of episodes in the TR, hyperoxaemia, hypoxaemia and the trend over 28 days using a linear random intercept model.

Results 23 preterm infants (median gestation 25.7 weeks; birth weight 820 g) were randomised. Compared with M-FiO2, the time spent within TR was higher in the A-FiO2 group (68.7% vs 48.0%, p<0.001). Infants in the A-FiO2 group spent less time in hyperoxaemia (13.8% vs 37.7%, p<0.001), but no difference was found in hypoxaemia. The time-based analyses showed that the A-FiO2 efficacy may differ over time, especially for hypoxaemia. Compared with the M-FiO2 group, the A-FiO2 group had a larger intercept but with an inversed slope for the daily median area below the TR (intercept 70.1 vs 36.3; estimate/day −0.70 vs 0.69, p<0.001).

Conclusion A-FiO2 control was superior to manual control in keeping preterm infants on non-invasive respiratory support in a prespecified TR over a period of 28 days. This improvement may come at the expense of increased time below the TR in the first days after initiating A-FiO2 control.

Trial registration number NTR6731.

  • Intensive Care Units, Neonatal
  • Neonatology
  • Respiratory Medicine

Data availability statement

Data are available upon reasonable request. Data are available upon reasonable request. Deidentified individual participant data (including data dictionaries) will be made available in addition to study protocol, the statistical analysis plan and the analytic code. The data will be made available upon publication to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal. Proposals should be submitted to WO, email: w.onland@amsterdamumc.nl.

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