Preterm births occur in about 10 percent of all pregnancies in the U.S. and account for approximately 69% of annual infant deaths;the remaining 31% [1,2] of infant mortality is attributable to known at-risk infants and other deaths (e.g., sudden infant death syndrome). While neonatology and neonatal intensive care units (NICUs) have greatly raised the survival rate of at-risk, very low birth weight, and extremely premature infants, approximately 30,000 American babies under the age of one still die each year . Currently, at-risk infants are monitored by attaching a host of devices and sensors with significant cabling that often generates parental anxiety and complicates treatment;no easy and effective at-home solution exists. To reduce infant mortality and provide an improved alternative to the existing newborn care, Physical Optics Corporation (POC) proposes to develop a Wireless At-Risk Infant Monitoring (WARM) system based on flexible electronics and sensors, low-power wireless communication, and highly flexible conformal packaging technologies. The WARM is a single unit consisting of multiple miniature sensors that may act individually or in concert to monitor and report on a variety of baby vital signs, including ECG, pulse-ox, skin temperature, motion detection, EPG, and blood pressure. Respiratory rate will derive from ECG readings in combination with EPG and chest motion. The innovation in conformal electronics enables the monitor to offer a lightweight, low-profile, reusable flexible flower-shaped "petal patch" (Petal Patch) device for at-risk infants. WARM's wireless communications avoids a plethora of wired cables, greatly improving infant comfort, reducing anxiety in visiting parents, and preventing motion artifacts and false alarms caused by moving cables. The Petal Patch achieves high-precision electrode placement that enables the ECG electrodes to be placed at appropriate distances and provide accurate measurements, reducing human error and making it ideal for at-home use. As a result, the innovative medical monitor system will impact the health of 4 million babies born each year in the U.S. Thus, the proposed device supports the NIH stated mission to use knowledge to enhance health, lengthen life, and reduce the burdens of illness and disability. The goal of this Small Business Innovation Research (SBIR) Phase I is to demonstrate an initial working prototype medical monitor system by designing, building, and testing a stand-alone battery- powered sensor that lasts up to 5 days in a lightweight package no wider than 7.5 cm (3 in.) utilizing input from the project consultant, Dr. Cherry Uy of UC Irvine Medical Center, NICU, who will provide insight into the critical needs of the NICU and treatment of at-risk infants. Successful demonstration in Phase I will lead to integration of additional sensors in Phase II along with complete wireless system integration utilizing additional consulting input from Dr. Uy who will help define a clinical testing plan for the WARM system. Successful completion of the project will expand the knowledge base for portable medical monitor systems in general and lead to a specific solution for newborns whose chest size is much smaller than an adult's.
The proposed portable medical monitor system will offer a simple solution for measuring the vital health signs of at-risk newborn babies and can be used in neonatal intensive care units and home settings.