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.
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.
