The purpose of this project is to develop a diagnostic test to assess whether the umbilical cord can provide equivalent or superior information to meconium for the identification of fetal drug exposure. Maternal drug use causes numerous medical complications for both mother and child. While there are many success stories of effective intervention for newborns diagnosed with in utero drug exposure, many affected neonates are missed due to collection of the wrong specimen, or sample unavailability. In this project, we propose to determine the diagnostic viability of the umbilical cord, in comparison to the "gold standard" of meconium testing. The umbilical cord is available for analysis in all births, regardless of in utero distress or errors in urine and meconium collection. The ability to diagnose neonates at birth will increase their chances of receiving appropriate intervention; decrease overall healthcare costs dramatically and, with proper intervention greatly enhance the quality of life of a new family. Drugs of abuse are routinely detected in newborns using urine and/or meconium samples. Urine gives only a 2-3 day history of drug exposure, and meconium, while providing up to a 20-week history is not always present due to in utero distress. Therefore, in order to accurately diagnose as many exposed newborns as possible, a widely available specimen giving a good historical measurement of substance abuse is necessary. During Phase I, the analysis of paired meconium and umbilical cord samples for drugs of abuse is proposed in order to determine whether umbilical cord will provide the same information as meconium. If the analytical approach is feasible, the data produced will be able to determine whether the umbilical cord samples can be used to replace meconium and urine collections for the testing of all newborns potentially exposed to drugs. Further phases of the project will include extending the drug test panel and the analysis of alcohol bio-markers in the umbilical cord. Commercialization areas of the test involve primary care providers, who will be able to identify drug and alcohol exposure in all newborns using an easily collected, historically accurate, widely available sample type. The overall goal is to develop a diagnostic test to assess fetal drug and alcohol exposure based on the analysis of the umbilical cord.
Thesaurus Terms: alcoholism /alcohol abuse, diagnosis design /evaluation, diagnosis quality /standard, drug abuse, drug detection, embryo /fetus toxicology, maternal behavior, newborn human (0-6 weeks), umbilical cord biomarker, feces, rapid diagnosis behavioral /social science research tag, clinical research, enzyme linked immunosorbent assay, human subject, immunologic assay /test, sample collection