Project Lead(s): Ratul Narain, Dinesh Krishna
Hypothermia is increasingly recognized as a major cause of neonatal morbidity and mortality in resource-poor settings.
The World Health Organization (WHO) recognizes newborn thermal care as a critical and essential component of essential newborn care; however, hypothermia continues to remain under-documented, under-recognized and under-managed.
The BEMPU Hypothermia Bracelet monitors a newborn’s temperature continuously.
If hypothermia develops, the device sounds an alarm, alerting the parent to warm their child by Kangaroo Mother Care well before hypoxia, hypoglycemia or more serious complications can occur.
The wrist was chosen as a measurement site because it becomes cold earlier than the core, enabling early intervention.
A study of 27 neonates was undertaken to continuously monitor, record and correlate abdomen, wrist and ankle temperatures, using a specific temperature-monitoring, wearable, clinical prototype device.
Data from this and other research, as well as the available clinical literature, were processed to create an accurate algorithm for early detection of mild hypothermia (also known as cold stress) with newborns.
A safe, functional and appealing physical version of the prototype was created using hypoallergenic medical-grade silicon rubber encasing a plastic housing. Within the body of the band is an electronic circuit with temperature probes, a microprocessor, lights and buzzers, all powered by a low-power, small battery.
The device was piloted with 27 doctors, 24 families and 93 neonates to collect utility feedback.
To validate the accuracy of the device in its ability to detect mild hypothermia, a large, independent study was done. The results show that the device has a sensitivity of 98.7%, specificity of 95.0%, positive predictive value of 83.45% and a negative predictive value of 99.6% for the detection of mild hypothermia.
Doctor feedback indicated that 89% of doctors who used the device said they would recommend it be used in their practice. With 86% of families using this device in the NICU or postnatal wards, parent feedback indicated that 84% of families continued the use of the device in their homes.
All mothers who used the device used corrective care when the alarm sounded, including Kangaroo Mother Care, swaddling or seeking medical intervention.
Approximately 1,000 babies were protected from hypothermia across 150 hospitals in 19 states of India through use of the device, and 484 cases of true hypothermia were detected and prevented early.
The BEMPU hypothermia bracelet went from concept to market within one year of receiving funding. The device is now stocked in several private hospitals across India and is in pilot programs with three state governments in India.
The team plans to apply for Transition to Scale (TTS) funding to scale private and government penetration in India and internationally.