SBIR-STTR Award

Fetal brain injury resulting from hypoxia and ischemia during labor is an important cause of death and long-term disability. However, little is known about fetal brain oxygenation and hemodynamics because there are currently no satisfactory clinical techniques for fetal monitoring. There is a need for a new method to assess fetal deep brain oxygenation. The proposed cerebral oxygenation monitor (COM) can potentially give an early-warning of cerebral injury through intrauterine monitoring. This would be of extreme value in guiding the clinician toward a course of action during the delivery. Analase, the leading medical near infrared spectrometer manufacturer, has teamed with Rose Biomedical Development Corp (RBDC), a strong clinical organization, to develop a compact, low cost intensity modulated laser spectrometer for the noninvasive measurement of hemoglobin (Hb) and oxyhemoglobin (HbO2) in fetal and neonatal deep brain tissue. Total hemoglobin and Saturation will be calculated and displayed along with absolute Hb and HbO2 concentrations. The proposed instrument is significantly less complex than conventional near infrared spectrometers. The Phase I project will build a prototype COM, verify accuracy and safety on simulated brain tissue and conduct clinical studies. PROPOSED COMMERCIAL APPLICATIONS: Market research shows over 80% of birthing sites in the U.S. will acquire an under $1,000 continuous, noninvasive, intrauterine fetal cerebral oxygenation monitor.

Thesaurus Terms:
biomedical equipment development, brain injury, cerebral ischemia /hypoxia, embryo /fetus hypoxia, embryo /fetus monitoring, laser spectrometry, noninvasive diagnosis, patient monitoring device birth, oxyhemoglobin clinical research, female, human pregnant subject, infrared spectrometry, newborn human (0-6 weeks), phantom model

Obstetricians have long sought a means of directly monitoring fetal hypoxia during labor. Electronic fetal monitoring has gained widespread use, despite its limitations as a strategy to detect the ramifications of hypoxia as seen on the fetal tracing. Ultimately, however, what is most desired is to know not surrogates or secondary measures, but actual measurements of the fetal oxygenation of brain tissue in a non-invasive, low cost manner with real- time feedback. Analase, a manufacturer of analytical lasers for medicine, has teamed with the University of Colorado Health Science Center (UCHSC), to develop a compact, low cost laser spectrometer for the noninvasive measurement of hemoglobin (Hb) and oxyhemoglobin (HbO2) in fetal and neonatal deep brain tissue. In Phase I, we successfully built the prototype Cerebral Oxygenation Monitor (COM) with distributed feedback lasers (DFB), verified the safety, calibrated COM with tissue phantoms and collected pilot data on 26 postpartum neonates. Building on this success, in Phase II, we will replace the DFB lasers with compact, low cost vertical cavity surface emitting lasers (VCSEL), which will allow us to build an intrauterine probe, and test the second generation COM with a significant sample of fetuses during labor. Analase has brought together a comprehensive, fully integrated team of engineers and clinician researchers to design, build and calibrate the Phase II COM, and conduct clinical studies on fetal and neonatal subjects. PROPOSED COMMERCIAL APPLICATIONS: Market research shows over 80% of birthing sites in the US will acquire a noninvasive, intrauterine fetal cerebral oxygenation monitor if it costs less than $1,000.