Remote Biomonitoring (RBM) for Temperature Surveillance of Mothers and Newborns: Pre-clinical and Clinical Evaluation

Based on client needs and technological requirements, a wearable sensor device was designed and developed using principles of \'social innovation\' design. The device underwent multiple iterations in product design and engineering based on user-feedback and then following pre-clinical testing, a techno-feasibility study and clinical trial were undertaken in a tertiary-care, teaching hospital in Bangalore, India. Clinical trial phases I and IIa {studies/pilot studies designed to demonstrate clinical efficacy or biological activity (\'proof of concept\' studies)} for evaluation of safety and efficacy were undertaken in the following sequence: first with healthy adult volunteers; then healthy mothers; healthy babies; stable babies in the Neonatal intensive care unit (NICU) and then a baby with morbidities. Time-stamped skin temperatures obtained at 5-minute intervals over a 1-hour period from the device secured on upper arms of mothers and abdomen of neonates were compared against readings from thermometers used routinely in clinical practice, radiant warmer and multimodal sensor