Device for measuring blood concentrations of unbound bilirubin in neonates

DESCRIPTION (provided by applicant): The overall goal of this project is to develop a test for measuring the concentration of unbound unconjugated bilirubin (Bf) to more accurately diagnose than current methods, bilirubin-induced neurotoxicity in newborns.Although more than 70% of newborns have elevated blood bilirubin levels, for most infants this hyperbilirubinemia is benign. However, for some infants bilirubin effects can be neurotoxic, resulting in deficits ranging from reversible hearing defects to the more severe and possibly fatal neurological sequelae of kernicterus. In particular very poor outcomes occur in extremely low birth weight (ELBW) infants where approximately 25-30% die and an additional 25-30% have severe neurologic deficits (e.g. cerebral palsy). This is presumed to be due to bilirubin neurotoxicity. Bilirubin neurotoxicity in neonates is currently assessed by monitoring total serum bilirubin (TSB) and high levels cause phototherapy and/or exchange transfusion to be initiated. Howeve