DIAGNOSTIC VIABILITY OF UMBILICAL CORD SPECIMENS

描述（由申请人提供）：本项目的目的是开发一种诊断测试，以评估脐带是否可以提供与胎粪相同或更好的信息来识别胎儿药物暴露。母亲吸毒会给母亲和孩子造成许多并发症。虽然有许多对诊断为子宫内药物暴露的新生儿进行有效干预的成功案例，但由于采集错误的标本或无法获得样本，许多受影响的新生儿被遗漏。在这个项目中，我们建议确定脐带的诊断能力，与胎粪测试的“金标准”相比。脐带可用于所有新生儿的分析，无论宫内窘迫或尿液和胎便收集错误。在出生时诊断新生儿的能力将增加他们接受适当干预的机会；大幅降低整体医疗保健成本，并通过适当的干预大大提高新家庭的生活质量。

DESCRIPTION (provided by applicant): 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.