临床试验/NCT00510016

NCT00510016已完成2 期

Efficacy of Clonidine in the Treatment of Neonatal Abstinence Syndrome: A Prospective, Double Blind, Randomized Controlled Trial

National Institute on Drug Abuse (NIDA)1 个研究点分布在 1 个国家目标入组 80 人开始时间: 2002年7月最近更新: 2017年1月11日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: National Institute on Drug Abuse (NIDA)
入组人数: 80
试验地点: 1
主要终点: Length of treatment for neonatal abstinence syndrome

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To test the hypothesis that the combination of the tincture of opium (DTO) and clonidine will be more effective in treating infants with neonatal abstinence syndrome (opioid withdrawal) than tincture of opium (DTO) alone.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double

入排标准

年龄范围: — 至 14 Days（Child）
性别: All
接受健康志愿者: 否

入选标准

未提供

排除标准

•< 35 weeks gestational age
•Intrauterine growth retardation defined as <5%tile of gestational age
•postnatal treatment with barbiturates or benzodiazepines,
•major congenital anomalies
•major concomitant medical illness requiring oxygen therapy, intravenous fluids or medications.
•breastfed infants

研究组 & 干预措施

Clonidine treatment

Experimental

Infants intrauterine exposed to opioids (heroin or methadone) that demonstrate signs and symptoms of withdrawal with withdrawal scores (modified Finnegan score) greater than 9 on to consecutive scores taken 4 hours apart.

干预措施: Clonidine HCL (Drug)

结局指标

主要结局

Length of treatment for neonatal abstinence syndrome

时间窗: duration of the treatment

次要结局

未报告次要终点

研究者

发起方

National Institute on Drug Abuse (NIDA)

申办方类型

Nih

研究点 (1)

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