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Sponsors and Collaborators: |
The Hospital for Sick Children The International Study Group for Neuroendoscopy (ISGNE) The International Society for Pediatric Neurosurgery (ISPN) |
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Information provided by: | The Hospital for Sick Children |
ClinicalTrials.gov Identifier: | NCT00652470 |
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.
Condition | Intervention | Phase |
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Hydrocephalus |
Procedure: Endoscopic Third Ventriculostomy Procedure: CSF Shunt Insertion |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | International Infant Hydrocephalus Study: A Multicentre, Prospective Study |
Estimated Enrollment: | 182 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | September 2011 |
Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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ETV: Active Comparator |
Procedure: Endoscopic Third Ventriculostomy
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.
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CSF Shunt: Active Comparator |
Procedure: CSF Shunt Insertion
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.
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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:
Ages Eligible for Study: | up to 24 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Abhaya Kulkarni, MD | 416-813-6427 | abhaya.kulkarni@sickkids.ca |
Contact: Shlomi Constanti, MD |
Principal Investigator: | Abhaya Kulkarni, MD | The Hospital for Sick Children, Toronto Canada |
Principal Investigator: | Shlomi Constantini, MD | Dana Children's Hospital, Tel Aviv Medical Center |
Principal Investigator: | Spyros Sgouros, MD | Birmingham Children's Hospital |
Responsible Party: | The Hospital for Sick Children ( Abhaya Kulkarni ) |
Study ID Numbers: | 1000007601 |
Study First Received: | March 31, 2008 |
Last Updated: | April 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00652470 |
Health Authority: | Canada: Ethics Review Committee |
infants Hydrocephalus Cerebrospinal Fluid Shunt Ventriculostomy neurosurgery |
Pseudotumor cerebri Pseudotumor Cerebri Infant, Newborn, Diseases Central Nervous System Diseases |
Hydrocephalus Brain Diseases Intracranial Hypertension Hypertension |
Nervous System Diseases |