A Study Comparing Two Treatments for Infants With Hydrocephalus
Tracking Information| Start Date ICMJE | September 2005 |
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| Estimated Primary Completion Date | September 2011 (final data collection date for primary outcome measure) |
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Current Primary Outcome Measures ICMJE
(submitted: March 31, 2008) | Health Status Outcome as measured by the Health Utilities Index - 2 [ Time Frame: At 5 years of age ] [ Designated as safety issue: Yes ] |
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| Original Primary Outcome Measures ICMJE | Same as current |
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| Change History | Complete list of historical versions of study NCT00652470 on ClinicalTrials.gov Archive Site |
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Current Secondary Outcome Measures ICMJE
(submitted: March 31, 2008) | - Death [ Time Frame: Duration of the Study ] [ Designated as safety issue: Yes ]
- Neurodevelopment as measured by the Denver Developmental Screening Test [ Time Frame: Up to 3 years of Age ] [ Designated as safety issue: Yes ]
- Health status outcome using the Hydrocephalus Outcome Questionnaire [ Time Frame: At 5 years of Age ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
- Number of Subsequent Hydrocephalus-Related Operations [ Time Frame: Duration of the Study ] [ Designated as safety issue: Yes ]
- Surgical Morbidity [ Time Frame: Duration of the Study ] [ Designated as safety issue: Yes ]
- Incidence of failure of initial intervention [ Time Frame: Duration of the Study ] [ Designated as safety issue: Yes ]
- Hospitalization Time [ Time Frame: 5 years post-operation ] [ Designated as safety issue: No ]
- Need for repeat radiological scans [ Time Frame: Duration of the Study ] [ Designated as safety issue: No ]
- Complications such as CNS infection, focal neurological deficit, significant hemorrhage, seizures requiring medication [ Time Frame: Duration of the Study ] [ Designated as safety issue: Yes ]
- Ventricular size and the existence of flow void (ETV group)assessed through radiological evaluation [ Time Frame: 3 years of age ] [ Designated as safety issue: Yes ]
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| Original Secondary Outcome Measures ICMJE | Same as current |
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Descriptive Information| Brief Title ICMJE | A Study Comparing Two Treatments for Infants With Hydrocephalus |
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| Official Title ICMJE | International Infant Hydrocephalus Study: A Multicentre, Prospective Study |
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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. |
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| 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).
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| Study Phase | Phase II |
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| Study Type ICMJE | Interventional |
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| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
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| Condition ICMJE | Hydrocephalus |
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| Intervention ICMJE | - 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. - 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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| Study Arms / Comparison Groups | |
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Recruitment Information| Estimated Enrollment ICMJE | 182 |
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| Estimated Completion Date | September 2011 |
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| Estimated Primary Completion Date | September 2011 (final data collection date for primary outcome measure) |
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| Eligibility Criteria ICMJE | 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
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| Gender | Both |
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| Ages | up to 24 Months |
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| Accepts Healthy Volunteers | No |
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| Contacts ICMJE | |
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| Location Countries ICMJE | United States, Argentina, Brazil, Canada, Former Serbia and Montenegro, Germany, Hungary, India, Israel, Italy, Netherlands, Poland, Russian Federation, Spain, Turkey, United Kingdom |
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Administrative Information| NCT ID ICMJE | NCT00652470 |
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| Responsible Party | Abhaya Kulkarni, The Hospital for Sick Children |
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| Study ID Numbers ICMJE | 1000007601 |
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| Study Sponsor ICMJE | The Hospital for Sick Children |
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| Collaborators ICMJE | - The International Study Group for Neuroendoscopy (ISGNE)
- The International Society for Pediatric Neurosurgery (ISPN)
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| Investigators ICMJE | | 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 | |
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| Information Provided By | The Hospital for Sick Children |
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