Topiramate as an Adjuvant to Therapeutic Hypothermia for Infants With Hypoxic Ischemic Encephalopathy
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Number of Patients With Seizures
研究概览
简要总结
The goal is to see whether topiramate (an anti-epileptic agent) improves the outcome of babies with neonatal hypoxic encephalopathy who are receiving whole body cooling.
详细描述
Hypoxic ischemic encephalopathy (HIE) is a devastating and unexpected disease in newborns that affects 1.5-2.6 per 1000 live births. Hypoxic ischemic encephalopathy has a mortality rate of up to 30% and survivors are at significant risk for adverse long-term outcomes, including seizures, cerebral palsy, and developmental delay. The investigators propose a randomized controlled study comparing therapeutic hypothermia alone, or therapeutic hypothermia combined with topiramate. The investigators hypothesize that adjuvant therapy with topiramate will reduce short term severity of HIE including seizures (the primary outcome), a composite HIE severity score, and reduce the time of normalization of the amplitude integrated EEG (aEEG). The investigators further hypothesize, that it will improve longer term outcomes such as developmental outcome. The primary hypothesis is that seizures before hospital discharge (or before 4 weeks post-natal age (which ever is earlier)) will be significantly reduced in the topiramate group compared to the control group
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 6 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In order to be eligible for cooling the baby must meet all three of the following sets of criteria
- •Be near term (typically ≥34wks gestation) and be aged < 6h old
- •Have signs of early perinatal depression (EITHER 10 minute Apgar score < 5, OR pH < 7.00 within 60mins of age, OR Base Excess < -12 within 60mins of age, OR need respiratory support at 10min of age due to respiratory depression)
- •Have signs of moderate or severe encephalopathy based on either clinical examination or on amplitude integrated aEEG assessment
排除标准
- •Known congenital myopathy
- •Known congenital neuropathy
研究组 & 干预措施
Placebo
Subjects will receive the standard of care intervention for HIE at our institution (whole body cooling for 72h followed by gradual rewarming)
干预措施: Placebo (Drug)
Topiramate
In addition to whole body cooling, infants assigned to the topiramate group will receive 5mg/kg of topiramate daily enterally for a total of 5 doses. The first dose will be administered as soon as possible on admission.
干预措施: Topiramate (Drug)
结局指标
主要结局
Number of Patients With Seizures
时间窗: At 4 weeks post-natal age or the time of hospital discharge (whichever is earlier)
Clinical or electrical seizures occuring before hospital discharge or before 4w post-natal age (which ever is earlier) will be compared between the topiramate and control groups.
次要结局
未报告次要终点
研究者
Kristin R Hoffman
Assistant Professor of Clinical Pediatrics
University of California, Davis