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临床试验/NCT00653692
NCT00653692已完成不适用

Methadone, Buprenorphine and Fetal Neurobehavior

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2007年5月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lauren M. Jansson

Associate Professor of Pediatrics Johns Hopkins University School of Medicine

National Institute on Drug Abuse (NIDA)

研究点 (1)

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Fetal Neurobehavior in Poly-drug Dependent Women | 临床试验