Status:
COMPLETED
A Study Comparing Two Treatments for Infants With Hydrocephalus
Lead Sponsor:
The Hospital for Sick Children
Collaborating Sponsors:
The International Study Group for Neuroendoscopy (ISGNE)
The International Society for Pediatric Neurosurgery
Conditions:
Hydrocephalus
Eligibility:
All Genders
1-24 years
Phase:
PHASE2
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 ve...
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 intracran...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2018
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT00652470
Start Date
September 1 2005
End Date
May 1 2018
Last Update
September 10 2018
Active Locations (22)
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1
Children's Medical Center of Dallas
Dallas, Texas, United States, 75235
2
Nacional de Pediatria
Buenos Aires, Argentina
3
Biocor Instituto
Nova Lima, Brazil
4
UNIFESP
São Paulo, Brazil