Fetal and Infant Neurobehavioral Effects of maternal Buprenorphine Treatment

母体丁丙诺啡治疗对胎儿和婴儿神经行为的影响

• 批准号: 8153652
• 负责人: LAUREN M JANSSON
• 金额: $ 51.41万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-08-01 至 2016-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8153652
• 关键词: Affect; Age-Months; Birth; Buprenorphine; Clinical; Clinical Research; Complex; Cross-Sectional Studies; Data; Data Collection; Dependency; Development; Digestive Signs and Symptoms; Dose; Exhibits; Fetus; Functional disorder; Gestational Age; Goals; Guidelines; Incidence; Infant; Infant autonomic nervous system; Knowledge; Maintenance; Mediating; Methadone; Mothers; Neonatal; Neonatal Abstinence Syndrome; Nervous system structure; Neurobiology; Newborn Infant; Opiates; Opioid; Outcome; Patients; Perinatal; Pharmaceutical Preparations; Physiological; Population; Pregnancy; Pregnant Women; Problem behavior; Provider; Recruitment Activity; Research; Research Personnel; Research Project Grants; Respiratory System; Safety; Schedule; Second Pregnancy Trimester; Severities; Study Subject; Symptoms; Techniques; Third Pregnancy Trimester; Time; Withdrawal; Woman; Work; cohort; experience; fetal; improved; in utero; interest; neonate; neurobehavior; neurobehavioral; pregnant; research facility

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. PUBLIC HEALTH RELEVANCE: Recent research has suggested the optimality of buprenorphine as compared to methadone for the treatment of opioid dependency during pregnancy principally due to improved neonatal outcomes, but there is no understanding of the effects of this medication on the developing fetus and infant. This proposal seeks to identify the longitudinal neurobehavioral effects of buprenorphine exposure on the developing fetus and newborn to adequately determine its safety for use during pregnancy and to fill critical gaps in knowledge. Information gained from this study can be used to fully inform clinical and FDA guidelines for the prescription of buprenorphine during pregnancy.

描述（由申请人提供）：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，目前人们对此知之甚少。婴儿表现出一系列变化很大的生理和行为问题，具有未知的病理生理学，并且以神经调节功能的显着缺陷为特征。该团队的研究表明，美沙酮会对妊娠晚期胎儿的神经行为产生负面影响，而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，妊娠期间丁丙诺啡维持治疗具有最佳性，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妊娠期间阿片类药物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。这组研究人员的初步数据表明，与暴露于美沙酮的胎儿相比，丁丙诺啡在妊娠中期和晚期表现出更佳的胎儿功能。通过这个拟议的研究项目，我们打算追踪暴露于丁丙诺啡的胎儿在整个妊娠期至 1 个月大期间的纵向神经行为发育，以确定妊娠期间使用该药物的安全性，以及由于妊娠期间母体生理变化之间的关系。丁丙诺啡给药和新生儿功能，并确定可预测 NAS 表达和婴儿神经行为结果的潜在胎儿神经行为标志物。将与美沙酮暴露妊娠的类似项目的结果进行比较。该提案旨在改进我们对阿片类药物依赖妇女在怀孕期间及其婴儿出生后的治疗的通知方式。 公共健康相关性：最近的研究表明，与美沙酮相比，丁丙诺啡在治疗妊娠期间阿片类药物依赖方面具有最佳效果，主要是因为改善了新生儿结局，但尚不清楚这种药物对发育中的胎儿和婴儿的影响。该提案旨在确定丁丙诺啡暴露对发育中的胎儿和新生儿的纵向神经行为影响，以充分确定其在怀孕期间使用的安全性并填补关键的知识空白。从这项研究中获得的信息可用于为怀孕期间丁丙诺啡处方的临床和 FDA 指南提供充分的信息。