Clinical feasibility of a contactless multiparameter continuous monitoring technology for neonates in a large public maternity hospital in Nairobi, Kenya

Amy Sarah Ginsburg,Dustin Dunsmuir,William M Macharia,J Mark Ansermino,Sahar Zandi Nia,Jesse Coleman,Sichen Liu,Dorothy Chomba,Guohai Zhou,Mary Waiyego,Roseline Ochieng

doi:10.1038/s41598-022-07189-1

Amy Sarah Ginsburg, Dustin Dunsmuir + Show 9 more

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https://doi.org/10.1038/s41598-022-07189-1

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Multiparameter continuous physiological monitoring (MCPM) technologies are critical in the clinical management of high-risk neonates; yet, these technologies are frequently unavailable in many African healthcare facilities. We conducted a prospective clinical feasibility study of EarlySense’s novel under-mattress MCPM technology in neonates at Pumwani Maternity Hospital in Nairobi, Kenya. To assess feasibility, we compared the performance of EarlySense’s technology to Masimo’s Rad-97 pulse CO-oximeter with capnography technology for heart rate (HR) and respiratory rate (RR) measurements using up-time, clinical event detection performance, and accuracy. Between September 15 and December 15, 2020, we collected and analyzed 470 hours of EarlySense data from 109 enrolled neonates. EarlySense’s technology’s up-time per neonate was 2.9 (range 0.8, 5.3) hours for HR and 2.1 (range 0.9, 4.0) hours for RR. The difference compared to the reference was a median of 0.6 (range 0.1, 3.1) hours for HR and 0.8 (range 0.1, 2.9) hours for RR. EarlySense’s technology identified high HR and RR events with high sensitivity (HR 81%; RR 83%) and specificity (HR 99%; RR 83%), but was less sensitive for low HR and RR (HR 0%; RR 14%) although maintained specificity (HR 100%; RR 95%). There was a greater number of false negative and false positive RR events than false negative and false positive HR events. The normalized spread of limits of agreement was 9.6% for HR and 28.6% for RR, which met the a priori-identified limit of 30%. EarlySense’s MCPM technology was clinically feasible as demonstrated by high percentage of up-time, strong clinical event detection performance, and agreement of HR and RR measurements compared to the reference technology. Studies in critically ill neonates, assessing barriers and facilitators to adoption, and costing analyses will be key to the technology’s development and potential uptake and scale-up.

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With an estimated 6700 newborn deaths every day globally, 47% of all deaths in children under 5 years of age occurred within the first month of life[1]
In a previous clinical trial, we evaluated the accuracy of this novel Multiparameter continuous physiological monitoring (MCPM) technology to measure heart rate (HR) and respiratory rate (RR) in neonates when compared to a verified reference technology[8]
We evaluated EarlySense’s MCPM technology’s clinical feasibility in a large public maternity hospital in Africa

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Introduction

With an estimated 6700 newborn deaths every day globally, 47% of all deaths in children under 5 years of age occurred within the first month of life[1]. At Kenyatta National Hospital in Nairobi, only 3 to 24% of neonates were observed to have their vital signs recorded within the first hour of life, and more than half (56%) did not receive heart rate (HR) or respiratory. While medical technologies may be accurate in more controlled settings, critical to evaluate are their accuracy and the clinical feasibility of use in uncontrolled, real-world settings. These types of evaluation are often not adequately conducted, which has implications for the technology’s eventual adoption, uptake, and scale-up. We assessed EarlySense’s technology using objective measures of feasibility that included up-time (periods of adequate signal quality), clinical event detection performance, and sustained accuracy in a real-world environment[11]

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