With improvements in neonatal and reproductive medicine, greater numbers of premature neonates are surviving that require hospital and home cardiorespiratory monitoring. Investigators have developed a method for acquiring an infant's heart rate at the abdomen and back without the use of electrodes. This new method has been combined with a previously developed FDA 510K cleared wireless respiratory rate sensor. Both sensors have been integrated into a single belt, worn at the abdomen, and transmit cardiorespiratory data wirelessly to a bedside monitor. NIH Phase II development was followed by clinical trials in a clinical setting at the Neonatal Intensive Care Unit (NICU) at Children's National Medical Center and Yale University Children's hospital for reliability, safety, and general acceptability. This low cost, electrodeless, and wireless design could 1) replace aging monitoring equipment at Level I/II care nurseries, in the home, and in neonatal transport equipment at dramatically reduced costs;2) introduce cardiorespiratory monitoring into areas of neonatal care where it was previously cost prohibitive;3) improve ease and comfort by which infants, parents, and caregivers interact;and 4) improve compliance in the in home setting as well as reduce incidence of false alarms due to elimination of shifting electrodes. Continuing objectives of this competing grant are to obtain FDA 510K clearance on the combined wireless monitor by multicenter clinical studies and to IP enable the wireless monitor so as to seamlessly monitor patients remotely on secure Web sites. The final form factor and user interface will also be designed and optimized. The wireless and disposable features of this technology define this as a value-added product that should appeal to innovative companies desirous of increased sales, market share and profitability while simultaneously lowering health care costs via offering inexpensive, easy to use non- invasive infant monitoring.
Providing a low-cost wireless cardio respiratory monitor that uses no electrodes such as the one proposed could have far reaching effects in the overall delivery of health care quality and cost when monitoring infants in the NICU as well as step down, lower level care units and in home monitoring settings. The ease of application and lack of wires will increase compliance with in home monitoring protocols as well as allow for better bonding of parents in and out of hospital settings.