Skip to main content
OpenTrials
Completed

NCT Number: NCT00652470

A Study Comparing Two Treatments for Infants With Hydrocephalus

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

1 day–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nacional de Pediatria, Buenos Aires, Argentina

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic third ventriculostomy

Procedure

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.

CSF Shunt Insertion

Procedure

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.

Primary outcomes

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

    Time frame: At 5 years of age

Secondary outcomes

  1. Death

    Time frame: Duration of the Study

  2. Neurodevelopment as measured by the Denver Developmental Screening Test

    Time frame: Up to 3 years of Age

  3. Health status outcome using the Hydrocephalus Outcome Questionnaire

    Time frame: At 5 years of Age

  4. 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

  5. Number of Subsequent Hydrocephalus-Related Operations

    Time frame: Duration of the Study

  6. Surgical Morbidity

    Time frame: Duration of the Study

  7. Incidence of failure of initial intervention

    Time frame: Duration of the Study

  8. Hospitalization Time

    Time frame: 5 years post-operation

  9. Need for repeat radiological scans

    Time frame: Duration of the Study

  10. Complications such as CNS infection, focal neurological deficit, significant hemorrhage, seizures requiring medication

    Time frame: Duration of the Study

  11. Ventricular size and the existence of flow void (ETV group)assessed through radiological evaluation

    Time frame: 3 years of age

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • The International Society for Pediatric Neurosurgery
  • The International Study Group for Neuroendoscopy (ISGNE)

Registry information

Official study title

International Infant Hydrocephalus Study: A Multicentre, Prospective Study

Important dates

Study start
2005
Primary completion
2018
Study completion
2018
First posted
Apr 3, 2008
Registry last updated
Sep 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.