Cerebral Oxygenation Monitor

Period of Performance: 09/30/1998 - 03/31/1999

Unknown

Phase 1 SBIR

Recipient Firm

Nostix, LLC
Boulder, CO 80301
Principal Investigator

Abstract

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.