Pharmacokinetics and Safety of IV Levetiracetam (Keppra) in Full Term and Preterm Neonates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Pharmacokinetic profile
研究概览
简要总结
The primary objective of this study is to determine the pharmacokinetic profile of a loading dose of intravenous levetiracetam, given for clinical reasons, in term and late preterm infants with seizures. Secondary objectives are to evaluate the safety and efficacy of levetiracetam in term and preterm infants with seizures.
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
- 1 Day 至 30 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age ≥ 32 weeks
- •Postnatal age ≤ 30 days
- •Birth weight ≥ 2000 grams
- •Admitted to the NICU at Cincinnati Children's Hospital or Good Samaritan Hospital
- •Clinical or electrographic seizures of any etiology
- •Seizures or seizure prophylaxis requiring treatment with levetiracetam
- •Parental consent obtained
排除标准
- •Infants with renal insufficiency indicated by serum creatinine > 2.0 at any time
- •Infants who have previously received levetiracetam
- •Parents refuse consent
- •Attending physician does not wish the infant to be enrolled in the study
- •Infants who are currently receiving an investigational drug
研究组 & 干预措施
Infants with seizures
干预措施: levetiracetam (Drug)
结局指标
主要结局
Pharmacokinetic profile
时间窗: 24 hours after dose
Blood specimens for quantitation of levetiracetam and its metabolite L057 will be obtained from an indwelling vascular catheter not used for study drug infusion or by heel stick in three different sampling schedules: Group 1 (n=6): at times 2-15 minutes after the end of infusion, 1-2 hours, and 12 hours post start of infusion Group 2 (n=6): at times 2-15 minutes after the end of infusion, 2-4 hours, and 18 hours post start of infusion Group 3 (n=6): at times 2-15 minutes after the end of infusion, 4-8 hours, and 20-24 hours post start of infusion
次要结局
- Change in vital sign baseline(24 hours)
- Number of participants with adverse events(24 hours)