As part of Goal 3's focus on treatment and prevention of acute illness, investments are needed to develop and/or optimize innovations in newborn care. Specifically, we hope to develop newborn care technologies that are low cost, operator-independent, and highly efficient.

An additional evaluation site for promising devices is needed to allow optimization of the devices for use in neonates and in low-resource settings (LRS). This investment, Evaluation of Technologies for Neonates in Africa (ETNA) project, will be to manage the continued development and evaluation at an African site of selected newborn care devices currently in development. The initial candidates will fall within the multiparameter continuous monitoring device category. Of the initial candidates, there are two potential devices that we would like to optimize for newborns in the neonatal intensive care setting and evaluate whether they could be included in the NEST package in a LRS.

• Early Sense contact-free monitoring pad: EarlySense is an established organization with significant experience in vital signs, contact-free monitoring. The current device from EarlySense is placed under the patient's mattress, using piezoelectric technology to monitor heart rate (HR), respiratory rate (RR), patient motion, and sleep status. This technology is used in combination with artificial intelligence analytics to predict sepsis, respiratory depression, sleep apnea, and arrhythmias, among a few other conditions. The current device is designed to measure children and adults above 10kg. This investment will be a proof-of-concept to establish the applicability of the EarlySense system to this specific population. The scope will include software and algorithm modifications that will allow the EarlySense technology to measure newborns in their cribs.
• Northwestern University advanced neonatal (ANNE) epidermal system sensors: There are currently two newborn non-invasive adhesive sensors being refined to allow wireless, advanced monitoring for neonatal intensive care. One sensor contains Bluetooth technology with a built-in battery, estimated to cost about $30 USD; whereas the second sensor is battery-free, ultra-thin and is estimated to cost about $3 USD. They both measure electrocardiogram (ECG), oxygen saturation (Sp02), HR, RR, and skin temperature, and monitoring is supported by customized software. A small investment was made to validate these sensors against gold-standard FDA-cleared monitoring devices in healthy newborn subjects in Chicago.

To further reduce neonatal mortality rate in low resource settings (LRS) in Africa, research is needed to develop and optimize innovations in neonatal care, specifically technologies that are low cost, operator-independent, and highly efficient. The purpose of this study is to produce information and data regarding the performance of two existing multiparameter continuous physiological monitoring devices developed by device developers, EarlySense and Sonica. The clinical trial is intended to provide evidence to establish whether these investigational devices can reliably and accurately measure vital signs in neonates (when compared to verified reference devices) and to assess the feasibility, usability and acceptability of these devices for use in neonates in a LRS in Africa. The investigational devices’ performance will be compared against reference devices, Masimo Rad97^TM and Tempo Bleu Easy thermometer by Spengler, which are licensed for use in clinical practice. Qualitative data will also be collected through in-depth interview and analyzed to assess feasibility, usability and acceptability of the investigational devices among healthcare providers and hospital administrators, and acceptability among caregivers of enrolled neonates.   The study consists of two phases: 1) a verification and accuracy evaluation phase and 2) a clinical feasibility phase. The initial phase will be undertaken at Aga Khan University Hospital's neonatal high dependency unit and the clinical feasibility phase will be conducted at Pumwani Maternity Hospital. Study data will be collected electronically using tablets and/or laptops and transmitted for analysis, including the questionnaires regarding usability, feasibility, and acceptability. Written informed consent will be collected from mothers, fathers, and legal guardians of the newborns. Healthcare providers and hospital administrators involved in the ETNA study will be approached to participate in the qualitative portion of the study. Caregivers with a child enrolled in the study will also be approached to see if they are willing to participate in the qualitative portion of the study. Study data will be securely stored to ensure confidentiality.