SBIR-STTR Award

With improvements in neonatal and reproductive medicine, greater numbers of premature neonates are surviving that require hospital and home cardiorespiratory monitoring. Investigators propose a method for acquiring an infant's heart rate at the abdomen without the use of electrodes. This new method will be combined with a previously developed respiratory rate sensor. Both sensors will be integrated into a single belt, worn at the abdomen, and will each transmit cardiorespiratory data wirelessly to a bedside monitor. Following laboratory testing, this integrated monitor will be evaluated in a clinical setting at the Neonatal Intensive Care Unit (NICU) at Children's National Medical Center 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 eardiorespiratory monitoring into areas of neonatal care where it was previously cost prohibitive; and 3) improve the ease and comfort by which infants, parents, and caregivers interact. Phase II goals of this research are to: 1) adapt the respiratory sensor to distinguish between central, obstructed, or mixed apnea; 2) implement apnea and bradycardia event detection; 3) explore implementation of an oximetric sensor; and 4) expand the validation study beyond the NICU into other areas of neonatal care including home monitoring through multi-center studies. The wireless and disposable features of this technology define this as a value-added niche product that may appeal to larger competitors desiring to improve their market share by offering inexpensive, easy to use infant monitoring that prevents cross-contamination.

Thesaurus Terms:
biomedical equipment development, clinical biomedical equipment, heart rate, monitoring device, neonatal intensive care, portable biomedical equipment, premature infant human, respiratory airflow measurement bradycardia, respiratory disorder diagnosis bioengineering /biomedical engineering, clinical research, human subject, newborn human (0-6 weeks)

PGS has developed an innovative low cost infant monitoring technology that is completely wireless and requires no intimate patient contact. The PGS monitor combines a state-of-the-art FDA pre-market approved wireless noninvasive inductive respiration sensor with new photo sensor technology for acquiring heart rate, eliminating wires and electrodes. As medical advances improve, the survival rates of pre-term and low birth weight infants in the U.S. continue to rise along with the need for cost effective monitoring. A phase I feasibility study conducted at Children's National Medical Center, Washington D.C. demonstrated that a viable and stable physiological pulse pressure waveform could reliably be acquired at the umbilicus area of the abdomen on low birth-weight infants in the hospital's NICU. The abdominal area was previously deemed inappropriate for monitoring. We further combined the cardiac sensor with the existing PGS wireless inductive respiration sensor. The clinical data collected in the phase I study demonstrated that the PGS motion artifact rejection performance was superior to the reference pulse oximeter monitor. A phase II study is proposed to refine the PGS monitor design and to validate the event detection and recording features in a variety of care settings. Research activities will focus on 1) technical development, which will employ design guidelines to meet substantial equivalence to existing monitors and 2) clinical study, which is structured to support the clinical requirements for an FDA 510(k) application. These goals will be accomplished through a 9-month hardware and software development phase followed by two clinical studies. The long term goals will be to demonstrate the utility, ease of use and ultimate cost savings benefit to the current monitoring programs utilized in hospitals.

Thesaurus Terms:
biomedical equipment development, heart function, newborn human (0-6 weeks), patient monitoring device, portable biomedical equipment, respiratory function apnea, biomedical device power system, bradycardia, computer program /software, computer system design /evaluation, computer system hardware, heart rate clinical research, human subject