Evaluation of non-invasive continuous physiological monitoring devices for neonates in Nairobi, Kenya: a research protocol

Abstract

IntroductionContinuous physiological monitoring devices are often not available for monitoring high-risk neonates in low-resource settings. Easy-to-use, non-invasive, multiparameter, continuous physiological monitoring devices could be instrumental in providing appropriate care and improving outcomes for high-risk neonates in these low-resource settings.Methods and analysisThe purpose of this prospective, observational, facility-based evaluation is to provide evidence to establish whether two existing non-invasive, multiparameter, continuous physiological monitoring devices developed by device developers, EarlySense and Sibel, can accurately and reliably measure vital signs in neonates (when compared with verified reference devices). We will also assess the feasibility, usability and acceptability of these devices for use in neonates in low-resource settings in Africa. Up to 500 neonates are enrolled in two phases: (1) a verification and accuracy evaluation phase at Aga Khan University—Nairobi and (2) a clinical feasibility evaluation phase at Pumwani Maternity Hospital in Nairobi, Kenya. Both quantitative and qualitative data are collected and analysed. Agreement between the investigational and reference devices is determined using a priori-defined accuracy thresholds.Ethics and disseminationThis trial was approved by the Aga Khan University Nairobi Research Ethics Committee and the Western Institutional Review Board. We plan to disseminate research results in peer-reviewed journals and international conferences.Trial registration numberNCT03920761.

Comprehensive pregnancy monitoring with a network of wireless, soft, and flexible sensors in high- and low-resource health settings

“…Furthermore, the sensors are able to be used seamlessly across the entire continuum of maternal, fetal, and neonatal care. Additionally, as demonstrated by our previous work, neonatal vital signs can also be tracked with the same sensors in both high-resource and low-resource settings as well as support kangaroo care (22,48).…”

Evaluating neonatal medical devices in Africa

“…The Evaluation of Technologies for Neonates in Africa (ETNA) platform was conceived to advance and support the development and robust evaluation of point-of-care devices and digital tools, specifically for the management of at-risk neonates in Africa, where the need for such tools is greatest. 8 The ETNA testing platform provides essential opportunities for technology optimisation through iterative rounds of clinical testing and reevaluation in the target population. We are exploring whether selected investigational MCPM devices that have already been tested for safety can accurately and reliably measure vital signs in neonates (when compared with verified reference devices), and we are assessing the feasibility, usability, and acceptability of these devices for use in neonates.…”

“…We are exploring whether selected investigational MCPM devices that have already been tested for safety can accurately and reliably measure vital signs in neonates (when compared with verified reference devices), and we are assessing the feasibility, usability, and acceptability of these devices for use in neonates. 8 We are working to anticipate the many challenges (eg, unreliable electricity, limited internet access and reliability, and behaviour change communication) involved in implementing such devices in low-resource settings, and the need to consider these challenges carefully before the introduction of these devices.…”

Identification of thresholds for accuracy comparisons of heart rate and respiratory rate in neonates

“…The Evaluation of Technologies for Neonates in Africa (ETNA) platform aims to independently establish the accuracy and feasibility of novel MCPM technologies suitable for use in neonates in resource-constrained settings 7 . To determine accuracy and agreement, new technologies are compared against existing reference methods or technologies 8 .…”

“…To determine accuracy and agreement, new technologies are compared against existing reference methods or technologies 8 . However, before the comparison process can proceed, a clinical reference verification step is necessary to determine appropriate accuracy thresholds 7 . These a priori thresholds determine the target level of agreement required and thus, the success or failure of an investigational technology.…”