Diagnostic accuracy of an over-the-counter infant pulse oximeter for cardiorespiratory events

• Published in: Archives of disease in childhood. Fetal and neonatal edition p. fetalneonatal-2025-328540
• Main Authors: Travers, Colm P, Nakhmani, Arie, Armstead, Kimberly M, Benz, Rachel L, Foshee, Kathryn M, Carlo, Waldemar A
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group Ltd and Royal College of Paediatrics and Child Health 12.05.2025; BMJ Publishing Group LTD
• Subjects: Accelerometers; Accuracy; Agreements; Algorithms; Babies; Cardiac arrhythmia; FDA approval; Guardians; Heart rate; Hypoxemia; Infants; Neonatology; Original research; Oxygen saturation; Paediatrics; Pulse oximetry; Respiratory Medicine; Sensors; Smartphones; Weightlessness; United States > US; Massachusetts; Neonatology; Paediatrics; Respiratory Medicine
• ISSN: 1359-2998; 1468-2052; 1468-2052
• DOI: 10.1136/archdischild-2025-328540

ObjectiveTo determine the diagnostic accuracy of an over-the-counter infant pulse oximeter for cardiorespiratory events.DesignSingle-centre prospective diagnostic accuracy study.SettingUniversity of Alabama at Birmingham.PatientsInfants weighing ≥1500 g, <44 weeks’ postmenstrual age (PMA) and off ventilator/continuous positive airway pressure support.InterventionsTest device for 48 hours in addition to standard hospital monitors, ECG and pulse oximetry.Main outcome measuresData were time aligned and analysed using MATLAB. The coprimary outcomes were the diagnostic accuracy of the test device for the detection of events with heart rate (HR) <50 beats per minute (bpm) and events with oxygen saturations (SpO2) <80% for ≥3 s.Results66 infants with a median gestational age of 31 weeks (range 23–40) were studied at a median 35 weeks’ PMA (range 32–42) weighing 1930 g (range 1500–3605 g) from April to July 2023. The sensitivity for detection of HR <50 bpm ≥3 s was 6% and 39% for smoothed and raw data, respectively, while the specificity was >99% for both smoothed and raw data. The sensitivity for SpO2 <80% ≥3 s was 14% and 74%, while the specificity was >99% and 96% for smoothed and raw data, respectively. Sensitivity for bradycardia events was higher for events with longer durations and/or when using higher thresholds. Sensitivity was higher for hypoxaemia events with longer durations and/or when using higher thresholds.ConclusionAn over-the-counter infant pulse oximeter had high specificity for bradycardia and hypoxaemia events consistent with a low false alarm rate. Sensitivity improved with longer events and higher event thresholds.Trial registration numberNCT05774470.