OBJECTIVE: This study aims to evaluate the performance of the fabian-Predictive-Intelligent-Control-of-Oxygenation (PRICO) system for automated control of the fraction of inspired oxygen (FiO2). DESIGN: Multicentre randomised cross-over study. SETTING: Five neonatal intensive care units experienced with automated control of FiO2 and the fabian ventilator. PATIENTS: 39 infants: median gestational age of 27 weeks (IQR: 26-30), postnatal age 7 days (IQR: 2-17), weight 1120 g (IQR: 915-1588), FiO2 0.32 (IQR: 0.22-0.43) receiving both non-invasive (27) and invasive (12) respiratory support. INTERVENTION: Randomised sequential 24-hour periods of automated and manual FiO2 control. MAIN OUTCOME MEASURES: Proportion (%) of time in normoxaemia (90%-95% with FiO2>0.21 and 90%-100% when FiO2=0.21) was the primary endpoint. Secondary endpoints were severe hypoxaemia (<80%) and severe hyperoxaemia (>98% with FiO2>0.21) and prevalence of episodes ≥60 s at these two SpO2 extremes. RESULTS: During automated control, subjects spent more time in normoxaemia (74%±22% vs 51%±22%, p<0.001) with less time above and below (<90% (9%±8% vs 12%±11%, p<0.001) and >95% with FiO2>0.21 (16%±19% vs 35%±24%) p<0.001). They spent less time in severe hyperoxaemia (1% (0%-3.5%) vs 5% (1%-10%), p<0.001) but exposure to severe hypoxaemia was low in both arms and not different. The differences in prolonged episodes of SpO2 were consistent with the times at extremes. CONCLUSIONS: This study demonstrates the ability of the PRICO automated oxygen control algorithm to improve the maintenance of SpO2 in normoxaemia and to avoid hyperoxaemia without increasing hypoxaemia.

2 Department of Neonatology Poznan University of Medical Sciences Poznan Poland

Amsterdam Reproduction and Development Research Institute UMC Amsterdam The Netherlands

Departent of Neonatology Emma Children's Hospital UMC University of Amsterdam Amsterdam The Netherlands

Department of Neonatology Centre for Postgraduate Medical Education Warsaw Poland

Department of Neonatology Pomeranian Medical University in Szczecin Szczecin Poland

Department of Neonatology Ujastek Medical Cetner Krakow Poland

Department of Neontology Ujastek Medical Center Krakow Poland

Department of Obstetrics and Perinatology National Medical Institute Warsaw Poland

Faculty Biomedical Engineering Czech Technical University Prague Kladno Czech Republic

Neonatal Biophysical Monitoring and Cardiopulmonary Therapies Research Unit Poznan University of Medical Sciences Poznan Poland

Zobrazit více v PubMed

Sweet DG, Carnielli VP, Greisen G, et al. European consensus guidelines on the management of respiratory distress syndrome: 2022 update. Neonatology. 2023;120:3–23. doi: 10.1159/000528914. PubMed DOI PMC

Hagadorn JI, Furey AM, Nghiem T-H, et al. Achieved versus intended pulse Oximeter saturation in infants born less than 28 weeks' gestation: the Aviox study. Pediatrics. 2006;118:1574–82. doi: 10.1542/peds.2005-0413. PubMed DOI

van Zanten HA, Tan RNGB, van den Hoogen A, et al. Compliance in oxygen saturation targeting in Preterm infants: a systematic review. Eur J Pediatr. 2015;174:1561–72. doi: 10.1007/s00431-015-2643-0. PubMed DOI PMC

Askie LM, Darlow BA, Finer N, 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;319:2190–201. doi: 10.1001/jama.2018.5725. PubMed DOI PMC

Poets CF, Roberts RS, Schmidt B, et al. Association between intermittent hypoxemia or bradycardia and late death or disability in extremely Preterm infants. JAMA. 2015;314:595–603. doi: 10.1001/jama.2015.8841. PubMed DOI

Raffay TM, Dylag AM, Sattar A, et al. Neonatal intermittent hypoxemia events are associated with diagnosis of bronchopulmonary dysplasia at 36 weeks postmenstrual age. Pediatr Res. 2019;85:318–23. doi: 10.1038/s41390-018-0253-z. PubMed DOI PMC

Di Fiore JM, Bloom JN, Orge F, et al. A higher incidence of intermittent hypoxemic episodes is associated with severe retinopathy of prematurity. J Pediatr. 2010;157:69–73. doi: 10.1016/j.jpeds.2010.01.046. PubMed DOI PMC

Askie LM, Henderson-Smart DJ, Irwig L, et al. Oxygen-saturation targets and outcomes in extremely preterm infants. N Engl J Med. 2003;349:959–67. doi: 10.1056/NEJMoa023080. PubMed DOI

Abdo M, Hanbal A, Asla MM, et al. Automated versus manual oxygen control in preterm infants receiving respiratory support: a systematic review and meta-analysis. J Matern Fetal Neonatal Med. 2022;35:6069–76. doi: 10.1080/14767058.2021.1904875. PubMed DOI

Stafford IG, Lai NM, Tan K. Automated oxygen delivery for preterm infants with respiratory dysfunction. Cochrane Database Syst Rev. 2023;11:CD013294. doi: 10.1002/14651858.CD013294.pub2. PubMed DOI PMC

Salverda HH, Cramer SJE, Witlox RSGM, et al. Automated oxygen control in preterm infants, how does it work and what to expect: a narrative review. Arch Dis Child Fetal Neonatal Ed. 2021;106:215–21. doi: 10.1136/archdischild-2020-318918. PubMed DOI

Dani C, Pratesi S, Luzzati M, et al. Cerebral and splanchnic oxygenation during automated control of inspired oxygen (Fio2) in preterm infants. Pediatr Pulmonol. 2021;56:2067–72. doi: 10.1002/ppul.25379. PubMed DOI

Dijkman KP, Mohns T, Dieleman JP, 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;106:621–6. doi: 10.1136/archdischild-2020-320728. PubMed DOI

Hütten MC, Goos TG, Ophelders D, et al. Fully automated predictive intelligent control of oxygenation (PRICO) in resuscitation and ventilation of preterm lambs. Pediatr Res. 2015;78:657–63. doi: 10.1038/pr.2015.158. PubMed DOI

Bachman TE, Iyer NP, Newth CJL, et al. Thresholds for oximetry alarms and target range in the NICU: an observational assessment based on likely oxygen tension and maturity. BMC Pediatr. 2020;20:317. doi: 10.1186/s12887-020-02225-3. PubMed DOI PMC

Bachman TE, Newth CJL, Iyer NP, et al. Hypoxemic and hyperoxemic likelihood in pulse oximetry ranges: NICU observational study. Arch Dis Child Fetal Neonatal Ed. 2019;104:F274–9. doi: 10.1136/archdischild-2017-314448. PubMed DOI

Dijkman KP, Goos TG, Dieleman JP, et al. Predictive intelligent control of oxygenation in preterm infants: a two-center feasibility study. Neonatology. 2023;120:235–41. doi: 10.1159/000527539. PubMed DOI

Bachman T, Rafl J, LeMoyne R. Comparison of the relative effectiveness of automated Fio2 control in neonates of differing stability: individual patient analysis. EPNV Conf. 2023

Bachman TE, Onland W, van Kaam AH, et al. Frequency and duration of extreme hypoxemic and hyperoxemic episodes during manual and automatic oxygen control in preterm infants: a retrospective cohort analysis from randomized studies. BMC Pediatr. 2022;22:350. doi: 10.1186/s12887-022-03407-x. PubMed DOI PMC

Lim K, Wheeler KI, Jackson HD, et al. Lost without trace: oximetry signal dropout in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2015;100:F436–8. doi: 10.1136/archdischild-2014-308108. PubMed DOI

Bachman T, Roubik K. Crossover from automated to manual titration of Fio2 in the NICU: is there a transition lag? Clin Technol. 2016;46:37–40.