Predictive Intelligent Control of Oxygenation in Preterm Infants: A Two-Center Feasibility Study

Dijkman K.P.Goos T.G.b,c· Dieleman J.P.d· Mohns T.a· van Pul C.e,f· Andriessen P.a,f· Kroon A.A.b· Reiss I.K.b· Niemarkt H.J.a

Author affiliations

aDepartment of Neonatology, Máxima MC, Veldhoven, The Netherlands
bDivision of Neonatology, Department of Pediatrics, Erasmus MC, Rotterdam, The Netherlands
cDepartment of Biomedical Engineering, Delft University of Technology, Delft, The Netherlands
dMMC Academy, Máxima MC., Veldhoven, The Netherlands
eDepartment of Clinical Physics, Máxima MC, Veldhoven, The Netherlands
fDepartment of Applied Physics, TU/e Eindhoven, University of Technology, Eindhoven, The Netherlands

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Article / Publication Details

First-Page Preview

Abstract of Clinical Trials

Received: May 11, 2022
Accepted: October 07, 2022
Published online: December 08, 2022

Number of Print Pages: 7
Number of Figures: 2
Number of Tables: 2

ISSN: 1661-7800 (Print)
eISSN: 1661-7819 (Online)

For additional information: https://www.karger.com/NEO

Abstract

Introduction: Supplemental oxygen therapy is a mainstay of modern neonatal intensive care for preterm infants. However, both insufficient and excess oxygen delivery are associated with adverse outcomes. Automated or closed loop FiO2 control has been developed to keep SpO2 within a predefined target range more effectively. Methods: The aim of this study was to investigate the feasibility of closed loop FiO2 control by Predictive Intelligent Control of Oxygenation (PRICO) on the Fabian ventilator in maintaining SpO2 within a target range (88/89-95%) in preterm infants on different modes of invasive and noninvasive respiratory support. In two tertiary neonatal intensive care units, preterm infants with an FiO2 >0.21 were included and received an 8 h nonblinded treatment period of closed loop FiO2 control by PRICO, flanked by two 8 h control periods of routine manual control (RMC1 and RMC2). Results: 32 preterm infants were included (median gestational age 26 + 5 weeks [IQR 25 + 5–27 + 6], median birthweight 828 grams [IQR 704–930]). Six patients received invasive respiratory support, while 26 received noninvasive respiratory support (18 CPAP, 4 DuoPAP, and 4 nasal IMV). The time percentage within the SpO2 target range was increased with PRICO (74.4% [IQR 67.8–78.5]) compared to RMC1 (65.8% [IQR 51.1–77.8]; p = 0.011) and RMC2 (60.6% [IQR 56.2–66.6]; p < 0.001) with an estimated median difference of 6.0% (95% CI 1.2–11.5) and 9.8% (95% CI 6.0–13.0), respectively. Conclusion: In preterm infants on invasive and noninvasive respiratory supports, closed loop FiO2 control by PRICO compared to RMC is feasible and superior in maintaining SpO2 within target ranges.

© 2022 S. Karger AG, Basel

References Askie LM, Darlow BA, Finer N, Schmidt B, Stenson B, Tarnow-Mordi W, et al. Association between oxygen saturation targeting and death or disability in extremely preterm infants in the neonatal oxygenation prospective meta-analysis collaboration. JAMA. 2018 June 05;319(21):2190–201. van Zanten HA, Tan RNGB, van den Hoogen A, Lopriore E, te Pas AB. Compliance in oxygen saturation targeting in preterm infants: a systematic review. Eur J Pediatr. 2015 Dec 01;174(12):1561–72. Mitra S, McMillan D. Automated control of fraction of inspired oxygen: is it time for widespread adoption? Curr Opin Pediatr. 2021 Apr 01;33(2):209–16. Salverda HH, Cramer SJE, Witlox RSGM, Dargaville PA, Te Pas AB. Automated oxygen control in preterm infants, how does it work and what to expect: a narrative review. Arch Dis Child Fetal Neonatal Ed. 2021 March 01;106(2):215–21. Claure N, Bancalari E, D’Ugard C, Nelin L, Stein M, Ramanathan R, et al. Multicenter crossover study of automated control of inspired oxygen in ventilated preterm infants. Pediatrics. 2011 Jan 01;127(1):e76–83. Reynolds PR, Miller TL, Volakis LI, Holland N, Dungan GC, Roehr CC, et al. Randomised cross-over study of automated oxygen control for preterm infants receiving nasal high flow. Arch Dis Child Fetal Neonatal Ed. 2019 July 01;104(4):F366–71. Schwarz CE, Kreutzer KB, Langanky L, Wolf NS, Braun W, O’Sullivan MP, et al. Randomised crossover trial comparing algorithms and averaging times for automatic oxygen control in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2022 Jul 01;107(4):425–30. Sturrock S, Ambulkar H, Williams EE, Sweeney S, Bednarczuk NF, Dassios T, et al. A randomised crossover trial of closed loop automated oxygen control in preterm, ventilated infants. Acta Paediatr. 2021 Mar 01;110(3):833–7. Hallenberger A, Poets CF, Horn W, Seyfang A, Urschitz MS; CLAC Study Group. Closed-Loop Automatic Oxygen Control (CLAC) in preterm infants: a randomized controlled trial. Pediatrics. 2014 February 01;133(2):e379–85. Gajdos M, Waitz M, Mendler MR, Braun W, Hummler H. Effects of a new device for automated closed loop control of inspired oxygen concentration on fluctuations of arterial and different regional organ tissue oxygen saturations in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2019 Jul 01;104(4):F360–5. Dargaville PA, Marshall AP, Ladlow OJ, Bannink C, Jayakar R, Eastwood-Sutherland C, et al. Automated control of oxygen titration in preterm infants on non-invasive respiratory support. Arch Dis Child Fetal Neonatal Ed. 2022 Jan 01;107(1):39–44. Schwarz CE, Kidszun A, Bieder NS, Franz AR, Konig J, Mildenberger E, et al. Is faster better? A randomised crossover study comparing algorithms for closed-loop automatic oxygen control. Arch Dis Child Fetal Neonatal Ed. 2020 Jul 01;105(4):369–74. Ali SK, Jayakar RV, Marshall AP, Gale TJ, Dargaville PA. Preliminary study of automated oxygen titration at birth for preterm infants. Arch Dis Child Fetal Neonatal. 2022 Feb 09;107(5):539–544. Kaltsogianni O, Dassios T, Belbal R, Greenough A. Survey of closed-loop automated oxygen control systems in neonatal intensive care units. Acta Paediatr. 2022 May 01;111(5):1002–3. Hutten MC, Goos TG, Ophelders D, Nikiforou M, Kuypers E, Willems M, et al. Fully automated predictive intelligent control of oxygenation (PRICO) in resuscitation and ventilation of preterm lambs. Pediatr Res. 2015 Dec 01;78(6):657–63. Dijkman KP, Mohns T, Dieleman JP, van Pul C, Goos TG, Reiss IK, et al. Predictive Intelligent Control of Oxygenation (PRICO) in preterm infants on high flow nasal cannula support: a randomised cross-over study. Arch Dis Child Fetal Neonatal Ed. 2021 November 01;106(6):621–6. Dani C, Pratesi S, Luzzati M, Petrolini C, Montano S, Remaschi G, et al. Cerebral and splanchnic oxygenation during automated control of inspired oxygen (FiO2 ) in preterm infants. Pediatr Pulmonol. 2021 July 01;56(7):2067–72. Mitra S, Singh B, El-Naggar W, McMillan DD. Automated versus manual control of inspired oxygen to target oxygen saturation in preterm infants: a systematic review and meta-analysis. J Perinatol. 2018 April 01;38(4):351–60. Poets CF, Roberts RS, Schmidt B, Whyte RK, Asztalos EV, Bader D, et al. Association between intermittent hypoxemia or bradycardia and late death or disability in extremely preterm infants. JAMA. 2015 Aug 11;314(6):595–603. Sturrock S, Williams E, Dassios T, Greenough A. Closed loop automated oxygen control in neonates: a review. Acta Paediatr. 2019 Nov 12;109(5):914–22. McClure C, Jang SY, Fairchild K. Alarms, oxygen saturations, and SpO2 averaging time in the NICU. J Neonatal Perinatal Med. 2016;9(4):357–62. Salverda HH, Oldenburger NJ, Rijken M, Pauws SC, Dargaville PA, Te Pas AB. The effect of automated oxygen control on clinical outcomes in preterm infants: a pre- and post-implementation cohort study. Eur J Pediatr. 2021 Jul 01;180(7):2107–13. Salverda HH, Beelen DML, Cramer SJE, Pauws SC, Schalij-Delfos N, Te Pas AB. Clinical outcomes of preterm infants while using automated controllers during standard care: comparison of cohorts with different automated titration strategies. Arch Dis Child Fetal Neonatal Ed. 2022 May 16;2021-323690. Maiwald CA, Niemarkt HJ, Poets CF, Urschitz MS, Konig J, Hummler H, et al. Effects of closed-loop automatic control of the inspiratory fraction of oxygen (FiO2-C) on outcome of extremely preterm infants: study protocol of a randomized controlled parallel group multicenter trial for safety and efficacy. BMC Pediatr. 2019 Oct 21;19(1):363–9. Kaltsogianni O, Dassios T, Greenough A. Does closed-loop automated oxygen control reduce the duration of mechanical ventilation? A randomised controlled trial in ventilated preterm infants. Trials. 2022 Apr 08;23(1):276. Article / Publication Details

First-Page Preview

Abstract of Clinical Trials

Received: May 11, 2022
Accepted: October 07, 2022
Published online: December 08, 2022

Number of Print Pages: 7
Number of Figures: 2
Number of Tables: 2

ISSN: 1661-7800 (Print)
eISSN: 1661-7819 (Online)

For additional information: https://www.karger.com/NEO

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