Newborn Phosphatidylethanol Screening to Detect Fetal Alcohol Exposure in Uruguay

乌拉圭新生儿磷脂酰乙醇筛查以检测胎儿酒精暴露情况

• 批准号: 9116730
• 负责人: MICHAEL F. FLEMING
• 金额: $ 45.91万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-08-01 至 2019-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9116730
• 关键词: 18 year old; Adverse effects; Age; Alcohol consumption; Alcohols; Applications Grants; Behavioral; Biological; Biological Assay; Biological Markers; Birth; Blood; Caring; Child; Childhood; Clinical; Communities; Congenital Abnormality; Country; Cross-Sectional Studies; Data; Detection; Developing Countries; Development; Developmental Delay Disorders; Diagnosis; Disabled Persons; Early Diagnosis; Esters; Ethanol Metabolism; Exhibits; Fatty Acids; Fetal Alcohol Exposure; Fetal Alcohol Spectrum Disorder; Frequencies; Future; Goals; Hair; Half-Life; Healthcare; Heavy Drinking; Heel; Hospitals; Hour; Infant; International; Intervention; Interview; Kinetics; Learning; Measures; Meconium; Methods; Mothers; Nail plate; Neonatal Screening; Neurologic; Neuronal Plasticity; Newborn Infant; Patient Self-Report; Pattern; Pediatric Hospitals; Perinatology; Physicians; Pilot Projects; Predictive Value; Pregnancy; Pregnant Women; Prevalence; Problem behavior; Public Health; Public Policy; Recruitment Activity; Reporting; Research; Risk; Sampling; Schedule; Schools; Science; Sensitivity and Specificity; Social Security; Source; Spottings; Study Section; Technology; Teratogens; Testing; Time; Umbilical cord structure; United States; Uruguay; Woman; Work; alcohol consumption during pregnancy; alcohol exposure; alcohol research; binge drinking; design; disability; drinking; effective intervention; effective therapy; follow-up; formative assessment; handicapping condition; improved; innovation; maternal cigarette smoking; phosphatidylethanol; policy implication; prenatal; programs; public health relevance; screening; standard measure

 DESCRIPTION (provided by applicant): Prenatal alcohol exposure is the leading preventable cause of birth defects in the United States, producing an array of neurological, behavioral and physical abnormalities collectively known as Fetal Alcohol Spectrum Disorders (FASD). Early diagnosis of FASD is the key to effective interventions and treatments, particularly for children under the age of 3 who may benefit from early neuroplasticity and reduce the long-term adverse effects. The long-term goal of our research program is to provide the science to support routine newborn screening for prenatal alcohol exposure. The primary aim of this international U01 grant proposal is to examine the association between maternal alcohol use and newborn phosphatidylethanol (PEth) levels in their newborn children, in a country (Uruguay) where significant alcohol use is common during pregnancy. Our previous work in public health care hospitals in Montevideo, Uruguay documented high rates of alcohol use during pregnancy (60%) and PEth levels in newborns (79%). PEth is a new biomarker that detects episodic heavy drinking (3 or more drinks) in the last 30 days. The test is 100% specific in detecting recent alcohol use with no known false positives. This proposed design is a cross-sectional study that will include1500 women 18 years and older and their newborns. Women who are admitted to one of two selected public health care hospitals in Montevideo, Uruguay for obstetrical care will be recruited to participate in the study. Maternal alcohol use will be assessed using a validated measure developed by Drs. Phil May and Wilsnack. The interview schedule has become the standard measure to assess maternal alcohol use and fetal alcohol exposure in the US and other countries. Maternal alcohol biomarker assays will include ethylglucuronide (EtG) in hair and nails and PEth in blood obtained at the time of delivery. Newborn umbilical cord and routine 48 hour heel stick blood will be collected to assess newborn PEth levels. By collecting newborn PEth levels at birth and 48 hours later we can assess the PEth kinetics to determine the optimum time to measure newborn PEth levels. By comparing newborn Peth levels with maternal self-reported alcohol use and alcohol biomarkers this innovative study will provide new information on the sensitivity and specificity of PEth as a newborn biomarker of prenatal alcohol exposure. The findings from this study could have enormous public health and policy implications, should PEth prove to be a highly sensitive and specific indicator of risky prenatal alcohol exposure. Analysis of PEth in dried blood spot cards would be the first assay to identify prenatal alcohol exposure in a universally available sample of newborn blood. Future work may also help us correlate newborn PEth levels with long-term behavioral, learning and developmental deficits in children and assist in early diagnosis of children with FASD.

 描述（由适用提供）：在美国，产前酒精暴露是可预防的先天缺陷的主要原因，产生了一系列神经系统，行为和身体异常，统称为胎儿酒精疾病（FASD）。 FASD的早期诊断是进行有效干预和治疗的关键，特别是对于3岁以下的儿童可能会从早期神经可塑性中受益并减少长期不良影响。我们的研究计划的长期目标是提供科学，以支持常规的新生儿筛查，以供产前酒精暴露。该国际U01赠款提案的主要目的是检查主要饮酒与新生儿的新生儿磷脂酰乙醇（Peth）水平之间的关联，在一个国家（乌拉圭），在怀孕期间很普遍的酒精使用。我们以前在蒙得维的亚公共保健医院的工作，乌拉圭记录了怀孕期间的饮酒率（60％）和新生儿的佩斯水平（79％）。佩斯（Peth）是一种新的生物标志物，在过去30天内检测到偶发性的大量饮酒（3杯或更多饮料）。该测试是100％特定于检测最近没有已知假阳性的饮酒。这项拟议的设计是一项横断面研究，其中包括18岁及以上的1500名妇女及其新生儿。将招募乌拉圭的两家选定的公共保健医院中的一家妇女，以参加该研究。将使用DRS开发的经过验证的测量值来评估孕产妇的使用。菲尔·梅（Phil May）和威尔斯纳克（Wilsnack）。面试时间表已成为评估美国和其他国家 /地区的饮酒和胎儿酒精暴露的标准衡量标准。孕妇醇生物标志物散布将包括头发和指甲中的乙基葡萄糖醛酸乙糖醛酸（ETG），以及在分娩时获得的血液中的peth。新生儿的脐带和常规绳将收集48小时的脚跟棒血液，以评估新生儿的佩斯水平。通过在出生时和48小时后收集新生儿Peth水平，我们可以评估Peth Kinetics，以确定测量新生儿Peth水平的最佳时间。通过将新生儿佩斯（Peth）水平与母体自我报告的酒精使用和酒精生物标志物进行比较，这项创新的研究将提供有关Peth作为产前酒精暴露的新生儿生物标志物的敏感性和特异性的新信息。这项研究的发现可能具有巨大的公共卫生和政策影响，如果Peth被证明是高度敏感且特定的危险产前酒精暴露的指标。在干血点卡中对Peth的分析将是第一个在普遍可用的新生儿样本中鉴定出产前酒精暴露的测定法。未来的工作也可能有助于我们将新生儿的佩斯水平与长期行为，学习和发展儿童的缺陷相关联，并协助FASD儿童的早期诊断。