57 3 Comparison of two devices for automated oxygen control in preterm infants Results The study ran from February 2019 to February 2020, during which consent was sought from 27 parent couples of which 15 agreed to participate (Figure 1). All participating infants (n=15, baseline characteristics Table 1) completed the crossover comparison. In one infant the second study period (OxyGenie control) was halted after 18 hours to allow treating clinicians to switch from CPAP to nasal high flow in response to nasal pressure areas. All study periods were included in the analysis. The total duration of recordings was 23 hours and 19 minutes (22:52-23:30) during OxyGenie control and 23 hours and 51 minutes (23:49-23:56) with the CLiO2 TM controller. A total of 2.9% (2.1%-5.0%) and 0.3% (0.2%-0.6%) of the time the SpO2 signal was missing, respectively. Figure 1: Consort flow diagram Assessed for eligibility (n=83) Excluded (n=68) • Not meeting inclusion criteria (n=56) • Declined to participate (n=12) Randomised (n=15) Allocated to CLiO2 control first (n=8) • Received allocated intervention (n=8) Allocated to OxyGenie control first (n=7) • Received allocated intervention (n=7) 1-hour washout period after switch in ventilator Switched to OxyGenie control (n=8) • Lost to follow up (n=0) • Discontinued intervention (n=0) Switched to CLiO2 control (n=7) • Lost to follow up (n=0) • Discontinued intervention (n=0) Analysed (n=15) • Excluded from analysis (n=0) Enrollment Analysis Allocation
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