A Study Comparing Two Treatments for Infants With Hydrocephalus
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 9/12/2018 |
| Start Date: | September 2005 |
| End Date: | May 1, 2018 |
International Infant Hydrocephalus Study: A Multicentre, Prospective Study
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.
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.
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).
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).
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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Children's Medical Center of Dallas Children's Medical Center is private, not-for-profit, and is the fifth-largest...
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