A Study Comparing Two Treatments for Infants With Hydrocephalus

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Brief Title

A Study Comparing Two Treatments for Infants With Hydrocephalus

Official Title

International Infant Hydrocephalus Study: A Multicentre, Prospective Study

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.
    

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 Phase

Phase 2

Study Type

Interventional


Primary Outcome

Health Status Outcome as measured by the Health Utilities Index - 2

Secondary Outcome

 Death

Condition

Hydrocephalus

Intervention

Endoscopic Third Ventriculostomy

Study Arms / Comparison Groups

 ETV
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

182

Start Date

September 2005

Completion Date

May 1, 2018

Primary Completion Date

May 1, 2018

Eligibility 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
      

Gender

All

Ages

1 Day - 24 Months

Accepts Healthy Volunteers

No

Contacts

Abhaya Kulkarni, MD, , 

Location Countries

Argentina

Location Countries

Argentina

Administrative Informations


NCT ID

NCT00652470

Organization ID

1000007601


Responsible Party

Principal Investigator

Study Sponsor

The Hospital for Sick Children

Collaborators

 The International Study Group for Neuroendoscopy (ISGNE)

Study Sponsor

Abhaya Kulkarni, MD, Principal Investigator, The Hospital for Sick Children, Toronto Canada


Verification Date

September 2018