A Study Comparing Two Treatments for Infants With Hydrocephalus
- Conditions
- Hydrocephalus
- Interventions
- Procedure: CSF Shunt InsertionProcedure: Endoscopic Third Ventriculostomy
- Registration Number
- NCT00652470
- Lead Sponsor
- The Hospital for Sick Children
- Brief Summary
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
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 182
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CSF Shunt CSF Shunt Insertion - ETV Endoscopic Third Ventriculostomy -
- Primary Outcome Measures
Name Time Method Health Status Outcome as measured by the Health Utilities Index - 2 At 5 years of age
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (22)
Nacional de Pediatria
🇦🇷Buenos Aires, Argentina
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Sanjay Gandhi Postgraduate Institute of Medical Sciences
🇮🇳Lucknow, India
Medical University of Silesia
🇵🇱Katowice, Poland
All India Institute of Medical Sciences
🇮🇳New Delhi, India
Dana Children's Hospital, Tel Aviv Medical Center
🇮🇱Tel Aviv, Israel
Children's Memorial Health Institute
🇵🇱Warsaw, Poland
Institute for Neurosurgery
🇷🇸Belgrade, Serbia
UNIFESP
🇧🇷Sao Paulo, Brazil
Biocor Instituto
🇧🇷Nova Lima, Brazil
University Hospital Gießen and Marburg
🇩🇪Giessen, Germany
Hacettepe University Hospital
🇹🇷Ankara, Turkey
Hospital Sant Joan de Deu
🇪🇸Barcelona, Spain
Polish Mother's Memorial Hospital
🇵🇱Lodz, Poland
Giannina Gaslini Hospital
🇮🇹Genova, Italy
University of Debrecen
🇭🇺Debrecen, Hungary
University Medical Center St Radboud
🇳🇱Nijmegen, Netherlands
Alder Hey Children's Hospital
🇬🇧Liverpool, United Kingdom
Birmingham Children's Hospital
🇬🇧Birmingham, United Kingdom
Children's Medical Center of Dallas
🇺🇸Dallas, Texas, United States
Burdenko Neurosurgical Institute
🇷🇺Moscow, Russian Federation
Catholic University Medical School Rome
🇮🇹Rome, Italy