Post-market Observation of a Wireless Vital Sign Monitor for Hospitalized Newborns in Kenya

This is an interrupted time series study conducted at the Moi Teaching and Referral Hospital (MTRH) neonatal ward between April 2022 and June 2023. Our study participants comprise of newborn patients admitted at MTRH during that period. The MTRH neonatal ward is arranged in 8 sub-units which comprise our comparison sub-groups. Newborns admitted from April-November 2022 comprise the pre-intervention arm and are not exposed to neoGuard, but receive existing standard-of-care vital sign monitoring. In December 2022, neoGuard was installed in 4 sub-units (intervention group), while the remaining 4 sub-units (comparison group) continued to use standard-of-care monitoring. The measurement of effectiveness will be performed at three levels: (1) device's ability to detect abnormal physiological signals and provide alerts/alarms that notify the nurses to check on a patient's status and; (2) alarms/alerts from level one that resulted in a necessary intervention being administered to the patient (valid alarms), versus all the alarms/alerts that did not necessitate an intervention (invalid alarms); (3) the month-to-month difference in newborn complication rates and treatment outcomes between the intervention group and comparison group. Medical staff who interact with neoGuard will participate in user surveys at the end of the intervention period to capture user experience and perceptions on feasibility and sustainability.