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A Study Comparing Two Treatments for Infants With Hydrocephalus

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ClinicalTrials.gov Identifier: NCT00652470
Recruitment Status : Completed
First Posted : April 3, 2008
Last Update Posted : September 10, 2018
Sponsor:
Collaborators:
The International Study Group for Neuroendoscopy (ISGNE)
The International Society for Pediatric Neurosurgery
Information provided by (Responsible Party):
Abhaya Kulkarni, The Hospital for Sick Children

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hydrocephalus Procedure: Endoscopic Third Ventriculostomy Procedure: CSF Shunt Insertion Phase 2

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: International Infant Hydrocephalus Study: A Multicentre, Prospective Study
Study Start Date : September 2005
Actual Primary Completion Date : May 1, 2018
Actual Study Completion Date : May 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hydrocephalus

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: ETV 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.
Active Comparator: CSF Shunt 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.


Outcome Measures
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Primary Outcome Measures :
  1. Health Status Outcome as measured by the Health Utilities Index - 2 [ Time Frame: At 5 years of age ]

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

Eligibility Criteria
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Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00652470


Locations
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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
Investigators
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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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Abhaya Kulkarni, Staff neurosurgeon, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00652470    
Other Study ID Numbers: 1000007601
First Posted: April 3, 2008    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018
Keywords provided by Abhaya Kulkarni, The Hospital for Sick Children:
infants
Hydrocephalus
Cerebrospinal Fluid Shunt
Ventriculostomy
neurosurgery
Additional relevant MeSH terms:
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Hydrocephalus
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases