A Study Comparing Two Treatments for Infants With Hydrocephalus

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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International Infant Hydrocephalus Study: A Multicentre, Prospective Study

Conditions
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Hydrocephalus

Intervention / Treatment
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* Procedure: Endoscopic Third Ventriculostomy
* Procedure: CSF Shunt Insertion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ETV<br> | Procedure: Endoscopic Third Ventriculostomy<br>* A standard frontal burr hole will be made and an endoscopic camera used to visualize the floor of the third ventricle. A ventriculostomy will be created in the floor of the third using the surgeon's own preferred method of perforation.<br>|
| Active Comparator: CSF Shunt<br> | Procedure: CSF Shunt Insertion<br>* The procedure involves creating a burr hole in the frontal or occipital regions and cannulating the ventricle with a silastic catheter. This is then attached to a valve mechanism and distal silastic tubing which runs subcutaneously in the peritoneal cavity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Status Outcome as measured by the Health Utilities Index - 2 |  | At 5 years of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death |  | Duration of the Study | 
| Neurodevelopment as measured by the Denver Developmental Screening Test |  | Up to 3 years of Age | 
| Health status outcome using the Hydrocephalus Outcome Questionnaire |  | At 5 years of Age | 
| 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 | 
| Number of Subsequent Hydrocephalus-Related Operations |  | Duration of the Study | 
| Surgical Morbidity |  | Duration of the Study | 
| Incidence of failure of initial intervention |  | Duration of the Study | 
| Hospitalization Time |  | 5 years post-operation | 
| Need for repeat radiological scans |  | Duration of the Study | 
| Complications such as CNS infection, focal neurological deficit, significant hemorrhage, seizures requiring medication |  | Duration of the Study | 
| Ventricular size and the existence of flow void (ETV group)assessed through radiological evaluation |  | 3 years of age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infants, Hydrocephalus, Cerebrospinal Fluid Shunt, Ventriculostomy, neurosurgery