Fetal and Infant Neurobehavior in Opiate Dependent Women

描述(由申请人提供)： 美沙酮被广泛用于阿片类药物依赖孕妇的治疗，但对其对发育中的胎儿的影响知之甚少。这组研究人员之前的研究发现，怀孕期间美沙酮治疗直接影响胎儿神经生理，而不是母亲的生理。母亲服用美沙酮与胎儿神经行为的显著抑郁有关。本建议旨在：1)采用单剂量美沙酮治疗，确定孕期美沙酮治疗对处于谷值和峰值水平的孕妇和胎儿神经行为功能的影响。这包括控制协变量，如调节或缓和这些影响的单个母婴因素，以及可能增强新生儿禁欲综合征表达的因素。2)确定孕妇分次剂量美沙酮治疗是否减轻或改善了先前观察到的单次剂量治疗对母体生理和胎儿神经行为功能的不良影响。3)确定丁丙诺啡治疗对母体生理和胎儿神经行为功能的影响，并与美沙酮治疗的阿片依赖孕妇进行比较。该提案的这一方面将与NIDA资助的多点、双盲、随机对照研究合作，评估丁丙诺芬与美沙酮对新生儿结局的影响。该项目将利用最先进的计算机化胎儿心动图和数据分析程序来同时评估胎儿运动和心率、两者之间的相互作用(耦合)和母体生理参数；以从PI获得的指导临床科学家奖获得的试点数据为基础，并汇集三个现有研究团队的专业知识。从这项提议中获得的信息有可能对我们治疗阿片依赖孕妇这一困难和高危人群的方式产生重大影响。

DESCRIPTION (provided by applicant): Methadone is widely used for the treatment of opioid dependent pregnant women, yet little is known about its effects on the developing fetus. Previous research by this group of investigators found that methadone treatment during pregnancy directly impacts fetal neurophysiology independently of maternal physiology. Maternal methadone administration was associated with significant depression in fetal neurobehaviors. This proposal seeks to: 1) Determine the effect of methadone treatment during pregnancy on maternal and fetal neurobehavioral functioning at trough and peak maternal methadone levels using single dose methadone therapy. This includes controlling for covariates such as individual maternal and fetal factors, which mediate or moderate these effects, and of factors that may potentiate the expression of neonatal abstinence syndrome. 2) Determine whether split dose methadone therapy for pregnant women lessens or ameliorates the previously observed deleterious effects of single dose treatment on maternal physiologic and fetal neurobehavioral functioning. 3) Determine the effects of buprenorphine treatment on maternal physiologic and fetal neurobehavioral functioning and compare them to those found in opioid dependent pregnant women treated with methadone. This aspect of the proposal will be in collaboration with the NIDA funded multi-site, double blind, randomized controlled study evaluating the effect of buprenoprphine versus methadone on neonatal outcome. The project will utilize a state-of-the-art computerized fetal actocardiograph and data analysis program to simultaneously evaluate fetal movement and heart rate, the interaction between the two (coupling) and maternal physiologic parameters; build upon pilot data obtained from a Mentored Clinical Scientist award received by the PI, and bring together the expertise of three established research teams. Information gained from this proposal has the potential to significantly impact the way in which we treat the difficult and high-risk population of opiate dependent pregnant women.