Objective To investigate the efficacy of automated control of inspired oxygen (FiO2) by Predictive Intelligent Control of Oxygenation (PRICO) on the Fabian ventilator in maintaining oxygen saturation (SpO2) in preterm infants on high flow nasal cannula (HFNC) support.
Design Single-centre randomised two-period crossover study.
Setting Tertiary neonatal intensive care unit.
Patients 27 preterm infants (gestational age (GA) <30 weeks) on HFNC support with FiO2 >0.25.
Intervention A 24-hour period on automated FiO2-control with PRICO compared with a 24-hour period on routine manual control (RMC) to maintain a SpO2 level within target range of 88%–95% measured at 30 s intervals.
Main outcome measures Primary outcome: time spent within target range (88%–95%). Secondary outcomes: time spent above and below target range, in severe hypoxia (SpO2 <80%) and hyperoxia (SpO2 >98%), mean SpO2 and FiO2 and manual FiO2 adjustments.
Results 15 patients received PRICO-RMC and 12 RMC-PRICO. The mean time within the target range increased with PRICO: 10.8% (95% CI 7.6 to 13.9). There was a decrease in time below target range: 7.6% (95% CI 4.2 to 11.0), above target range: 3.1% (95% CI 2.9 to 6.2) and in severe hypoxia: 0.9% (95% CI 1.5 to 0.2). We found no difference in time spent in severe hyperoxia. Mean FiO2 was higher during PRICO: 0.019 (95% CI 0.006 to 0.030). With PRICO there was a reduction of manual adjustments: 9/24 hours (95% CI 6 to 12).
Conclusion In preterm infants on HFNC support, automated FiO2-control by PRICO is superior to RMC in maintaining SpO2 within target range. Further validation studies with a higher sample frequency and different ventilation modes are needed.
Data availability statement
Data and deidentified patient data are available upon a reasonable request to the corresponding author.
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Contributors KPD: study design, data acquisition, data analysis and interpretation, manuscript drafting and revision. TM: study design, data acquisition, critical manuscript revision. JPD: data and statistical analysis, critical manuscript revision. CvP: data analysis, critical manuscript revision. TGG: data analysis, critical manuscript revision. IKMR: data interpretation, critical manuscript revision. PA: study design, critical manuscript revision. HJN: study design, data acquisition, data interpretation, critical manuscript revision. All authors approve of the final version of the manuscript and agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Funding This study was supported by an unrestricted research grant from Chiesi Pharmaceuticals BV, The Netherlands.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
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