Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Time From Initiation of Adjunctive Therapy Until Hospital Discharge
研究概览
简要总结
The purpose of this study is to compare clonidine versus phenobarbital as adjunctive therapy in those infants who have failed monotherapy with morphine sulfate for neonatal abstinence syndrome (NAS).
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
- None
入排标准
- 年龄范围
- 35 Weeks 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants greater than or equal to 35 weeks gestation age
- •Admitted to the neonatal intensive care unit
- •Failed monotherapy with morphine sulfate therapy
排除标准
- •Neonatal abstinence syndrome due to iatrogenic causes
- •Unable to take oral medications at any point during their treatment
- •Infants in the custody of the Department of Child Protective Services with no legal guardian identified at the time of enrollment
研究组 & 干预措施
Phenobarbital
Phenobarbital loading dose 20mg/kg in 2 divided doses, then 5 mg/kg/day divided every 12 hours. Phenobarbital continued throughout the infants hospitalization.
干预措施: Phenobarbital (Drug)
Clonidine
Clonidine 5 mcg/kg/day divided every 3 hours. Clonidine will be continued to achieve control of NAS symptoms. Clonidine may be weaned after successful discontinuation of oral morphine sulfate. Infants will not be discharged on clonidine.
干预措施: Clonidine (Drug)
结局指标
主要结局
Time From Initiation of Adjunctive Therapy Until Hospital Discharge
时间窗: From date of randomization until hospital discharge, up to 4 months
Number of days from initiation of adjunctive therapy until hospital discharge
次要结局
- Readmission Rate(From date of randomization until 30 days after hospital discharge or discontinuation of phenobarbital, up to 6 months)
- Length of Stay(From date of randomization until hospital discharge, up to 4 months)
- Length of Oral Morphine Sulfate Therapy(From date of randomization until hospital discharge, up to 4 months)
- Number of Patients Requiring Triple Therapy(From date of randomization until hospital discharge, up to 4 months)