Division of Clinical Pharmacology & Toxicology, The Hospital for Sick Children, Toronto, Ontario, Canada.
Ther Drug Monit. 2010 Jun;32(3):305-10. doi: 10.1097/FTD.0b013e3181dca381.
The main objective of this study is to evaluate the clinical utility of meconium analysis for fatty acid ethyl esters as a universal screening tool intended for the detection of newborns at risk for fetal alcohol spectrum disorder. This will be accomplished by assessing the rate of voluntary participation in a nonanonymous neonatal screening program and by determining the logistics of implementing the necessary follow-up and interventions as part of routine care. Additionally, this study will determine the predictive value of fatty acid ethyl ester-positive meconium with regard to neurodevelopmental delays. This is an ongoing prospective cohort study. Written informed consent is sought from all Grey Bruce women delivering at participating birthing sites. Collected meconium samples are tested for fatty acid ethyl esters by headspace-solid-phase microextraction followed by gas chromatography-mass spectrometry. Children with positive results are followed up through an existing public health program involving regular home visits and assessments of developmental milestones by a public health nurse. These children and matched control subjects also undergo neurodevelopmental testing at 3 and 18 months of age by a clinical psychologist using Bayley Scales of Infant and Toddler Development. If delays are detected, the child is referred to diagnostic services and appropriate intervention programs. This study has been granted ethics approval and enrollment began in November 2008 at St. Joseph's Health Care in London, Ontario. The first positive case has been identified and the follow-up is currently being conducted by the public health unit. The successful completing of this study will reveal the population's willingness to participate in a neonatal screening program for prenatal alcohol exposure and determine the costs, feasibility, and utility of implementing such programs in clinical practice.
本研究的主要目的是评估胎粪中脂肪酸乙酯分析作为一种通用筛查工具，用于检测胎儿酒精谱系障碍风险新生儿的临床实用性。这将通过评估自愿参与非匿名新生儿筛查计划的比率以及确定实施必要的后续行动和干预措施的后勤工作来实现，这些干预措施是常规护理的一部分。此外，本研究还将确定脂肪酸乙酯阳性胎粪在神经发育迟缓方面的预测价值。这是一项正在进行的前瞻性队列研究。所有在参与分娩地点分娩的安大略省格雷布鲁斯妇女都被要求签署书面知情同意书。收集的胎粪样本通过顶空固相微萃取后进行气相色谱-质谱分析，以检测脂肪酸乙酯。阳性结果的儿童通过现有的公共卫生计划进行随访，该计划涉及公共卫生护士定期家访和对发育里程碑的评估。这些儿童和匹配的对照对象还由临床心理学家使用贝利婴幼儿发育量表进行 3 个月和 18 个月的神经发育测试。如果发现发育迟缓，将儿童转介至诊断服务和适当的干预计划。本研究已获得伦理批准，2008 年 11 月在安大略省伦敦的圣约瑟夫医疗保健中心开始入组。已经确定了第一个阳性病例，目前由公共卫生部门进行随访。成功完成这项研究将揭示人群参与产前酒精暴露新生儿筛查计划的意愿，并确定在临床实践中实施此类计划的成本、可行性和实用性。
