Pharmacokinetics and Safety of 50 mg/kg IV Levetiracetam (Keppra) in Full Term and Preterm Neonates
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 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 50 mg/kg loading dose of intravenous levetiracetam (LEV) in term and late preterm infants with seizures. Secondary objectives are to evaluate the safety and efficacy of a 50 mg/kg loading dose of levetiracetam in term and preterm infants with seizures, and to obtain data on steady state drug levels of levetiracetam in neonates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 Neonatal Intensive Care Unit at Cincinnati Children's 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
结局指标
主要结局
Pharmacokinetic Profile
时间窗: 5-20 minutes after the dose, 1-2 hours after the dose, 6-10 hours after the dose, and possibly 4-7 days after loading dose (if infants remained on maintenance doses)
3 levels for levetiracetam and its metabolite L057 will be drawn: at 5-20 minutes after the dose, 1-2 hours after the dose, and 6-10 hours after the dose. In infants who remain on maintenance doses of the medication, a steady state level will be drawn 4-7 days after the loading dose. Outcome reported is clearance. The median maximum clearance rate was measured in each participant and determined by evaluating the levels of levetiracetam at each time point using MW Pharm.
次要结局
未报告次要终点
研究者
Stephanie Merhar, MD
Assistant Professor
Children's Hospital Medical Center, Cincinnati