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Clinically feasible multiparameter continuous physiological monitoring technologies are needed for use in resource-constrained African healthcare facilities to allow for early detection of critical events and timely intervention for major morbidities in high-risk neonates. We conducted a prospective clinical feasibility study of a novel multiparameter continuous physiological monitoring technology in neonates at Pumwani Maternity Hospital in Nairobi, Kenya. To assess feasibility, we compared the performance of Sibel's Advanced Neonatal Epidermal (ANNE) technology to reference technologies, including Masimo's Rad-97 pulse CO-oximeter with capnography technology for heart rate (HR), respiratory rate (RR), and oxygen saturation (SpO 2 ) measurements and Spengler's Tempo Easy non-contact infrared thermometer for temperature measurements. We evaluated key performance criteria such as up-time, clinical event detection performance, and the agreement of measurements compared to those from the reference technologies in an uncontrolled, real-world setting. Between September 15 and December 15, 2020, we collected and analyzed 503 h of ANNE data from 109 enrolled neonates. ANNE's up-time was 42 (11%) h more for HR, 77 (25%) h more for RR, and 6 (2%) h less for SpO 2 compared to the Rad-97. However, ANNE's ratio of up-time to total attached time was less than Rad-97's for HR (0.79 vs 0.86), RR (0.68 vs. 0.79), and SpO 2 (0.69 vs 0.86). ANNE demonstrated adequate performance in identifying high and low HR and RR and high temperature events; however, showed relatively poor performance for low SpO 2 events. The normalized spread of limits of agreement were 8.4% for HR and 52.2% for RR and the normalized root-mean-square deviation was 4.4% for SpO 2 . Temperature agreement showed a spread of limits of agreement of 2.8 °C. The a priori-identified optimal limits were met for HR and temperature but not for RR or SpO 2 . ANNE was clinically feasible for HR and temperature but not RR and SpO 2 as demonstrated by the technology's up-time, clinical event detection performance, and the agreement of measurements compared to those from the reference technologies., (© 2022. The Author(s).)

Background: Neonatal multiparameter continuous physiological monitoring (MCPM) technologies assist with early detection of preventable and treatable causes of neonatal mortality. Evaluating accuracy of novel MCPM technologies is critical for their appropriate use and adoption., Methods: We prospectively compared the accuracy of Sibel's Advanced Neonatal Epidermal (ANNE) technology with Masimo's Rad-97 pulse CO-oximeter with capnography and Spengler's Tempo Easy reference technologies during four evaluation rounds. We compared accuracy of heart rate (HR), respiratory rate (RR), oxygen saturation (SpO2), and skin temperature using Bland-Altman plots and root-mean-square deviation analyses (RMSD). Sibel's ANNE algorithms were optimized between each round. We created Clarke error grids with zones of 20% to aid with clinical interpretation of HR and RR results., Results: Between November 2019 and August 2020 we collected 320 hours of data from 84 neonates. In the final round, Sibel's ANNE technology demonstrated a normalized bias of 0% for HR and 3.1% for RR, and a non-normalized bias of -0.3% for SpO2 and 0.2°C for temperature. The normalized spread between 95% upper and lower limits-of-agreement (LOA) was 4.7% for HR and 29.3% for RR. RMSD for SpO2 was 1.9% and 1.5°C for temperature. Agreement between Sibel's ANNE technology and the reference technologies met the a priori-defined thresholds for 95% spread of LOA and RMSD. Clarke error grids showed that all HR and RR observations were within a 20% difference., Conclusion: Our findings suggest acceptable agreement between Sibel's ANNE and reference technologies. Clinical effectiveness, feasibility, usability, acceptability, and cost-effectiveness investigations are necessary for large-scale implementation., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: Shuai Xu is Founder and Chief Executive Officer at Sibel Health; all other authors declare no competing interests. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Background: Globally, 2.5 million neonates died in 2018, accounting for 46% of under-5 deaths. Multiparameter continuous physiological monitoring (MCPM) of neonates allows for early detection and treatment of life-threatening health problems. However, neonatal monitoring technology is largely unavailable in low-resource settings., Methods: In four evaluation rounds, we prospectively compared the accuracy of the EarlySense under-mattress device to the Masimo Rad-97 pulse CO-oximeter with capnography reference device for heart rate (HR) and respiratory rate (RR) measurements in neonates in Kenya. EarlySense algorithm optimisations were made between evaluation rounds. In each evaluation round, we compared 200 randomly selected epochs of data using Bland-Altman plots and generated Clarke error grids with zones of 20% to aid in clinical interpretation., Results: Between 9 July 2019 and 8 January 2020, we collected 280 hours of MCPM data from 76 enrolled neonates. At the final evaluation round, the EarlySense MCPM device demonstrated a bias of -0.8 beats/minute for HR and 1.6 breaths/minute for RR, and normalised spread between the 95% upper and lower limits of agreement of 6.2% for HR and 27.3% for RR. Agreement between the two MCPM devices met the a priori-defined threshold of 30%. The Clarke error grids showed that all observations for HR and 197/200 for RR were within a 20% difference., Conclusion: Our research indicates that there is acceptable agreement between the EarlySense and Masimo MCPM devices in the context of large within-subject variability; however, further studies establishing cost-effectiveness and clinical effectiveness are needed before large-scale implementation of the EarlySense MCPM device in neonates., Trial Registration Number: NCT03920761., Competing Interests: Competing interests: YSH and RK are employed by EarlySense. All other authors declare no competing interests., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

Obstructive Sleep Apnea (OSA) is the most common form of sleep-disordered breathing in children. The gold standard to screen for OSA, polysomnography (PSG), requires an overnight stay in the hospital and is resource intensive. The Phone Oximeter is a non-invasive smartphone-based tool to record pulse oximetry. This portable device is able to measure patients over multiple nights while at home, causing less sleep disturbance than PSG and is able to measure night to night variability in sleep. This study analyzed the Screen My Sleep children (SMS) dataset, in which 74 children were monitored over multiple nights with the Phone Oximeter, including one night simultaneously with PSG in the hospital and two nights at home. In this study, we aim to investigate the night to night variability and assess the accuracy of the oxygen desaturation index (ODI) screening for children with significant OSA. In order to assess the performance of the ODI calculation in children, we implemented different ODIs at different desaturation levels and time durations. The variability was studied using a one-way ANOVA, and ODI's performance screening for OSA using the area under the ROC curve (AUC). The implemented ODIs provide similar OSA screening results, using different apnea/hypopnea index (AHI) thresholds, as the ODI recommended for adults by the American academy of sleep medicine (AASM). The ODI provides an AUC of around 0.77, 0.76, 0.94 and 0.97 classifying children with an AHI > 1, AHI > 5 AHI > 10 and AHI > 15, respectively. The SMS dataset shows no significant night to night variability between the two nights at home. However, when comparing with the night at the hospital, both nights at home show a decrease in the lowest SpO 2 value as well as overall SpO 2 signal quality percentage. This study shows that there is variability in SpO 2 signal between at-home versus in hospital settings.