Fetal and Infant Neurobehavioral Effects of maternal Buprenorphine Treatment

说明(申请人提供)：阿片类药物依赖孕妇及其胎儿和婴儿是一个高度脆弱和复杂的群体，目前对此了解甚少。婴儿表现出一系列的生理和行为问题，这些问题变数很大，病理生理学未知，以神经调节功能严重缺陷为特征。该团队的研究表明，美沙酮对妊娠晚期的胎儿神经行为产生负面影响，新生儿神经调节功能障碍的严重程度与母婴自主神经系统活动有关。新的研究表明，与美沙酮相比，孕期丁丙诺啡维持治疗的效果最好，这主要是由于新生儿结局的改善，这可能会导致寻求这种药物治疗孕期阿片依赖的提供者和患者数量增加。然而，关于丁丙诺啡对发育中的胎儿和婴儿的影响的信息很少。这组研究人员的试验数据表明，与美沙酮暴露的胎儿相比，丁丙诺啡在妊娠中期和晚期表现出更理想的胎儿功能。在这项拟议的研究项目中，我们打算跟踪暴露于丁丙诺啡的胎儿从怀孕到1个月的纵向神经行为发育，以努力确定该药物在妊娠期间使用的安全性，丁丙诺啡给药引起的母体生理变化与新生儿功能之间的关系，并确定可能预测NAS表达和婴儿神经行为结果的潜在胎儿神经行为标记物。将与美沙酮暴露的怀孕中的类似项目的结果进行比较。这项建议旨在推进我们对怀孕期间的阿片依赖妇女及其出生后的婴儿的治疗方式。

DESCRIPTION (provided by applicant): The population of opioid dependent pregnant women and their fetuses and infants are a highly vulnerable and complex group that are currently poorly understood. Infants display a range of physiologic and behavioral problems that are widely variable, have unknown pathophysiology, and are characterized by significant deficits in neuroregulatory functioning. Research by this team has shown that methadone negatively affects fetal neurobehaviors in late gestation, and that severity of newborn neuroregulatory dysfunction is related to maternal and infant autonomic nervous system activity. New research has shown the optimality of buprenorphine maintenance during pregnancy as compared to methadone, principally due to improved neonatal outcomes, which is likely to result in increased numbers of providers and patients seeking this medication for treatment of opioid dependency during pregnancy. However, little information regarding the effects of buprenorphine on the developing fetus and infant exists. Pilot data from this group of investigators has suggested that buprenorphine, as compared to methadone-exposed fetuses, exhibit more optimal fetal functioning in the second and third trimesters of gestation. With this proposed research project, we intend to track the longitudinal neurobehavioral development of the buprenorphine-exposed fetus across gestation through 1 month of age in an effort to determine the safety of this medication for use during gestation, the relationship between maternal physiologic changes due to buprenorphine administration and newborn functioning, and to determine potential fetal neurobehavioral markers that may predict NAS expression and infant neurobehavioral outcome. Comparisons to results from a similar project in methadone-exposed pregnancies will be made. This proposal seeks to advance the way we inform the treatment of the opioid dependent woman during pregnancy and her infant after birth.