A Study Comparing Two Treatments for Infants With Hydrocephalus

Completed · Phase 2

Conditions studied: Hydrocephalus

In brief

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.

Key facts

Study ID

NCT00652470

Run by

The Hospital for Sick Children

People needed

182

Starts

2005-09-01

Expected to finish

2018-05-01

Last updated by the study team

2018-09-10

Who can join

Age: 0 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Medical Center of Dallas — Dallas, Texas, United States
• Nacional de Pediatria — Buenos Aires, Argentina
• Biocor Instituto — Nova Lima, Brazil
• UNIFESP — São Paulo, Brazil
• The Hospital for Sick Children — Toronto, Ontario, Canada
• University Hospital Gießen and Marburg — Giessen, Germany
• University of Debrecen — Debrecen, Hungary
• Sanjay Gandhi Postgraduate Institute of Medical Sciences — Lucknow, India
• All India Institute of Medical Sciences — New Delhi, India
• Dana Children's Hospital, Tel Aviv Medical Center — Tel Aviv, Israel
• Giannina Gaslini Hospital — Genova, Italy
• Catholic University Medical School Rome — Rome, Italy
• University Medical Center St Radboud — Nijmegen, Netherlands
• Medical University of Silesia — Katowice, Poland
• Polish Mother's Memorial Hospital — Lodz, Poland
• Children's Memorial Health Institute — Warsaw, Poland
• Burdenko Neurosurgical Institute — Moscow, Russia
• Institute for Neurosurgery — Belgrade, Serbia
• Hospital Sant Joan de Deu — Barcelona, Spain
• Hacettepe University Hospital — Ankara, Turkey (Türkiye)
• Birmingham Children's Hospital — Birmingham, United Kingdom
• Alder Hey Children's Hospital — Liverpool, United Kingdom

Full record on ClinicalTrials.gov

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