International Infant Hydrocephalus Study: A Multicentre, Prospective Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 182
- 试验地点
- 24
- 主要终点
- Health Status Outcome as measured by the Health Utilities Index - 2
研究概览
简要总结
The purpose of this study is to study whether infants with triventricular hydrocephalus (TVH) have a better long-term outcome at 5 years when they are treated with a new procedure, endoscopic third ventriculostomy (ETV), than infants treated with the more traditional treatment, insertion of a cerebrospinal fluid (CSF) shunt.
详细描述
TVH is a relatively uncommon condition in infants, in which CSF accumulates in the brain's ventricles due to a blockage in outflow at the level of cerebral aqueduct. This can cause increased intracranial pressure, with adverse effect on brain development. The causes of this include congenital aqueductal stensois or acquired aqueductal stenosis from previous brain hemorrhage or infection.
TVH is currently treated through one of the following two approaches:
- Extra-cranial CSF diversion through ventricular shunts. Extra-cranial shunting has been the standard approach over the past few decades, since functional shunts were first developed and inserted successfully.
- Intra-cranial internal CSF diversion using endoscopic techniques. The principles of internal diversion were clear from the time neurosurgeons first understood the nature of hydrocephalus. However, internal diversion was never really practical or successful on a large scale until the more recent development of neuroendoscopy. There is currently a revived interest in diversionary hydrocephalus treatment through neuroendoscopic surgical techniques, with the primary focus on endoscopic third ventriculostomy (ETV).
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
- None
入排标准
- 年龄范围
- 1 Day 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic TVH requiring treatment.
- •No previous treatment for TVH
- •Under 24 months of age at time of surgery
- •Full-term pregnancy (>36 weeks)
- •Mandatory pre-operative MRI that includes mid-sagittal T1 & T2 scans which show: Tri-ventricular pattern of hydrocephalus; proof of no flow through aqueduct; presence of CSF collection over the convexity and/or inter-hemispheric fissure is acceptable; configuration of third ventricle floor could vary; deformed tectal plate is acceptable; posterior fossa fluid collections may be included as long as: aqueduct is closed; vermis preserved (complete Dandy Walker Syndrome excluded); questionable flow in aqueduct acceptable as long as TVH exists
- •History or suggestion of intra-ventricular bleed (intra-uterine or post-natal) or intracranial infection qualifies (excluding intraventricular hemorrhage of prematurity).
- •Ability to participate in followup for at least 5 years
排除标准
- •Open Spina Bifida
- •Complete Dandy Walker syndrome (vermian agenesis / dysgenesis)
- •Prematurity
- •Perinatal asphyxia
- •Severe dysmorphic anatomical features or known chromos (e.g. agenesis of corpus callosum, heterotopias, large cysts)
- •intracranial tumor
研究组 & 干预措施
ETV
干预措施: Endoscopic Third Ventriculostomy (Procedure)
CSF Shunt
干预措施: CSF Shunt Insertion (Procedure)
结局指标
主要结局
Health Status Outcome as measured by the Health Utilities Index - 2
时间窗: At 5 years of age
次要结局
- Complications such as CNS infection, focal neurological deficit, significant hemorrhage, seizures requiring medication(Duration of the Study)
- Death(Duration of the Study)
- In-depth Evaluation of Neurodevelopment, Functioning and Intelligence, as mesured by the Weschler Intelligence Scale for Children or Weschler Preschool and Primary Scale of Intelligence(At 5 years of Age)
- Surgical Morbidity(Duration of the Study)
- Health status outcome using the Hydrocephalus Outcome Questionnaire(At 5 years of Age)
- Neurodevelopment as measured by the Denver Developmental Screening Test(Up to 3 years of Age)
- Incidence of failure of initial intervention(Duration of the Study)
- Number of Subsequent Hydrocephalus-Related Operations(Duration of the Study)
- Need for repeat radiological scans(Duration of the Study)
- Ventricular size and the existence of flow void (ETV group)assessed through radiological evaluation(3 years of age)
- Hospitalization Time(5 years post-operation)
研究者
Abhaya Kulkarni
Staff neurosurgeon
The Hospital for Sick Children