Methadone, Buprenorphine and Fetal Neurobehavior
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- fetal heart rate
研究概览
简要总结
This project examines fetal neurobehavior and maternal physiology in poly-drug dependent women. This study also evaluates infant neonatal abstinence syndrome, infant neurobehavior and vagal tone in the post-partum period.
详细描述
Little is known about the link between maternal physiology, fetal neurobehavior and neonatal abstinence syndrome in multiply drug-dependent women. Previous research by this group of investigators has found that the severity of neonatal abstinence syndrome in methadone exposed infants is related to maternal vagal tone changes in response to methadone during pregnancy. While previous research has focused on drug abstinent, methadone maintained women, most drug dependent pregnant women are poly-substance abusers who also use prescription psychiatric medications, alcohol and nicotine. This protocol seeks to further our understanding of the effects of multiple drugs on the fetus, including the co-variate effects of maternal psychological status. Infant neurobehavior and vagal tone will also be evaluated. This research will extend our knowledge of fetal neurobehavioral development and neonatal abstinence syndrome in a realistic population of poly-drug dependent women, potentially altering the way in which these women are evaluated and their infants monitored and treated for neonatal abstinence syndrome.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 41 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18-41
- •Single intrauterine fetus
- •Free of significant maternal or fetal significant health complications
排除标准
- •Development of significant maternal or fetal health complications
- •Significant maternal psychopathology that would preclude informed consent
- •Unwilling or unable to receive methadone at prescribed times
结局指标
主要结局
fetal heart rate
时间窗: 120 minutes
fetal movement
时间窗: 120 minutes
次要结局
- neonatal abstinence syndrome(4 days)
研究者
Lauren M. Jansson
Associate Professor of Pediatrics Johns Hopkins University School of Medicine
National Institute on Drug Abuse (NIDA)
