Assessing CSF Flow Dynamics in Pediatric Hemorrhagic Hydrocephalus
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of participants 1-2 weeks of age who present with continuing ventriculomegaly after CSF diversion as assessed by the clinical MRI examination
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of ventricular microdosing of indocyanine green (ICG) in order to assess cerebrospinal fluid (CSF) ventricular dynamics and extracranial CSF outflow using fluorescent Cap-based Transcranial Optical Tomography (fCTOT) and Near-InfraRed Fluorescent (NIRF) imaging and to evaluate inflammation markers of the CSF and to correlate with CSF ventricular dynamics, extracranial outflow into the lymphatics, ventriculomegaly, and patient's clinical outcome in order to understand how inflammation may impact that status of extracranial outflow.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children born premature currently in the NICU with a diagnosis of PHH who have undergone ventricular reservoir placement.
- •For the first four study subjects, we will attempt for the child to undergo CT cisternography when clinically stable 3-4 weeks after reservoir placement.
排除标准
- •Parents who do not consent for procedure on their child
- •Children who are deemed clinically unstable or unsuitable for imaging by clinical staff as defined by the subject's level of intensive care (e.g. can the subject be repositioned without compromise to the level of care needed or condition)
- •Children known or suspected to have allergy to iodine or ICG
- •Children who do not have a subcutaneous reservoir for CSF diversion from the lateral ventricle
研究组 & 干预措施
fCTOT and NIRF imaging with ICG
干预措施: fCTOT cap (Device)
fCTOT and NIRF imaging with ICG
干预措施: NIRF planar imaging (Device)
fCTOT and NIRF imaging with ICG
干预措施: ICG (Drug)
结局指标
主要结局
Number of participants 1-2 weeks of age who present with continuing ventriculomegaly after CSF diversion as assessed by the clinical MRI examination
时间窗: end of study (about 10 days form baseline)
Number of participants 1-2 months of age who present with elevated ventriculomegaly after Endoscopic Third Ventriculostomy (ETV)/Choroid Plexus Cauterization (CPC) as assessed by the clinical MRI examination
时间窗: end of study (about 10 days form baseline)
Number of participants 1-6 months of age who present with continuing ventriculomegaly after ETV/CPC as assessed by the clinical MRI examination
时间窗: end of study (about 10 days form baseline)
次要结局
- Amount of pro-inflammatory cytokines measured in pg/ml(end of study (about 10 days form baseline))
研究者
Eva Sevick
Professor
The University of Texas Health Science Center, Houston