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

Study setting: St John's Medical College Hospital, Bangalore, a 1300-bedded, tertiary-care hospital with 2500 deliveries per annum and a Level-3 nursery that takes care of 1000 neonates (inborn: outborn ratio = 2:1) in the neonatal care intensive unit (NICU) annually, one-third of whom are low birth weight and one-fifth are preterm.

Choice of site of temperature measurement in adult and newborn: In the adult, the upper arm was selected for continuous monitoring. While in the newborn abdominal skin temperature was selected. In addition to being close to the liver, a metabolically-active organ facilitating a measurement close to the core temperature, it is also a non-invasive method that is steady, continuous, easy-to-use and comfortable for the infant.

Innovation Pathway: The USAID 2006 Innovation Pathway model was adopted and it incorporated four steps from research to field implementation - (1) priority-setting phase and product design (2) product development and proof-of-concept (3) product introduction and (4) field implementation.As part of step 1, the sub-steps of (a) problem identification (epidemiologic/ technological/ social/ financial, etc), (b) critical review of temperature measurement devices and other issues (temperature sensors or thermistors, core body temperature measurement issues, etc), and (c) determination of niche of this device vis-à-vis other devices through horizon scanning.

Epidemiologic burden of chief causes of maternal and neonatal mortality and morbidity were reviewed as a first step.A technological review revealed that the device to be strapped-on to the mother or newborn for vital sign detection had to be a medical-grade device with extremely high safety profile. Further, it had to remain functional in situations such as soiling or wetting by the newborn, and also continue to work in different areas with varying population densities as well as buildings. Several devices such as the ThermoSpot®, a temperature sensor tag and remote infrared-based instruments were evaluated. Social review revealed that a sensor being continually strapped on to the body for long periods was not dissimilar to that of talismans strapped around the arms of adults or around the necks/waists of children and might therefore not be too disagreeable to families. A financial review revealed that for the device to be used widely, especially by low-income populations, it would have to be a low-cost device. Implementation review focused on possible uptake and utilization of such a device in rural, urban and slum communities.

Conceptual framework: The conceptual framework for remote monitoring consisted of five components: (1) a low-cost, wearable sensor tag; (2) a gateway device acting as an ultra-low-power 'real-time' communication link; (3) piggy-backing on a commercial cellular communication network; (4) smart data analytics system; and (5) feedback loop to the care-giver or frontline health worker. This framework was to be ideated, designed, prototyped and developed into a Class A medical device with lowest risk level as per Medical Device Regulatory Authority of India bearing in mind that the end-product should enable tenets of good Quality of Care (QoC) namely effectiveness, timeliness, safety, people-centeredness and equity.