Dose Optimization of Caffeine in Neonates With Hypoxic-Ischemic Encephalopathy
概览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 3
- 主要终点
- Apparent Caffeine Clearance
概览
简要总结
This is a phase Ib, open-label, dose-validating and safety study of caffeine in neonates with hypoxic-ischemic encephalopathy (HIE) undergoing therapeutic hypothermia.
详细描述
In a previous phase I trial (NCT03913221), the investigators characterized the pharmacokinetics (PK) of caffeine in the setting of HIE and therapeutic hypothermia using a population PK model. This is an open-label study of caffeine citrate in neonates with HIE to validate the population PK model and determine optimal dosing for HIE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 24 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented informed consent from parent or guardian
- •≥ 36 weeks gestational age at birth
- •Receiving therapeutic hypothermia for a diagnosis of HIE
- •Intravenous (IV) access
- •Postnatal age \< 24 hours
排除标准
- •Receiving \> 1 anti-epileptic drug for seizures
- •Sustained (\>4 hours) heart rate \> 180 beats per minute
- •Known major congenital anomaly
研究组 & 干预措施
Higher loading dose (30 mg/kg)
Within 24 hours after delivery, participants will receive a loading dose of 30 mg/kg caffeine citrate IV.
干预措施: Caffeine citrate 30 mg/kg (Drug)
Lower loading dose (20 mg/kg)
Within 24 hours after delivery, participants will receive a loading dose of 20 mg/kg caffeine citrate IV.
干预措施: Caffeine citrate 20 mg/kg (Drug)
结局指标
主要结局
Apparent Caffeine Clearance
时间窗: 7 samples will be collected after the first dose of study drug and up to 72 hours after final dose of study drug
Clearance is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Caffeine concentrations will be used to calculate population estimates of caffeine clearance, with inter-individual variabilty and residual variabilty .
Volume of Distribution of Caffeine
时间窗: 7 samples will be collected after the first dose of study drug and up to 72 hours after final dose of study drug
Caffeine concentrations will be used to calculate population estimates of volume of distribution with inter-individual variability and residual variability.
次要结局
- Number of Participants with Pre-Specified Adverse Events(From the first dose of caffeine to 7 days following the final dose.)
- Number of Participants with Abnormal MRI Brain Finding Score(During initial hospitalization, typically 3-5 postnatal days)
- Number of Participants with Death or Neurodevelopmental Impairment(18-24 months of age)