A Study Comparing Two Treatments for Infants With Hydrocephalus

This study is currently recruiting participants.
Verified September 2013 by The Hospital for Sick Children
Sponsor:
Collaborators:
The International Study Group for Neuroendoscopy (ISGNE)
The International Society for Pediatric Neurosurgery
Information provided by (Responsible Party):
Abhaya Kulkarni, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00652470
First received: March 31, 2008
Last updated: September 6, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Hydrocephalus
Procedure: Endoscopic Third Ventriculostomy
Procedure: CSF Shunt Insertion
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: International Infant Hydrocephalus Study: A Multicentre, Prospective Study

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Health Status Outcome as measured by the Health Utilities Index - 2 [ Time Frame: At 5 years of age ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Death [ Time Frame: Duration of the Study ] [ Designated as safety issue: Yes ]
  • Neurodevelopment as measured by the Denver Developmental Screening Test [ Time Frame: Up to 3 years of Age ] [ Designated as safety issue: Yes ]
  • Health status outcome using the Hydrocephalus Outcome Questionnaire [ Time Frame: At 5 years of Age ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Number of Subsequent Hydrocephalus-Related Operations [ Time Frame: Duration of the Study ] [ Designated as safety issue: Yes ]
  • Surgical Morbidity [ Time Frame: Duration of the Study ] [ Designated as safety issue: Yes ]
  • Incidence of failure of initial intervention [ Time Frame: Duration of the Study ] [ Designated as safety issue: Yes ]
  • Hospitalization Time [ Time Frame: 5 years post-operation ] [ Designated as safety issue: No ]
  • Need for repeat radiological scans [ Time Frame: Duration of the Study ] [ Designated as safety issue: No ]
  • Complications such as CNS infection, focal neurological deficit, significant hemorrhage, seizures requiring medication [ Time Frame: Duration of the Study ] [ Designated as safety issue: Yes ]
  • Ventricular size and the existence of flow void (ETV group)assessed through radiological evaluation [ Time Frame: 3 years of age ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 182
Study Start Date: September 2005
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ETV Procedure: Endoscopic Third Ventriculostomy
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.
Active Comparator: CSF Shunt Procedure: CSF Shunt Insertion
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.

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).
  Eligibility

Ages Eligible for Study:   up to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00652470

Contacts
Contact: Abhaya Kulkarni, MD 416-813-6427 abhaya.kulkarni@sickkids.ca
Contact: Shlomi Constanti, MD

  Show 22 Study Locations
Sponsors and Collaborators
The Hospital for Sick Children
The International Study Group for Neuroendoscopy (ISGNE)
The International Society for Pediatric Neurosurgery
Investigators
Principal Investigator: Abhaya Kulkarni, MD The Hospital for Sick Children, Toronto Canada
Principal Investigator: Shlomi Constantini, MD Dana Children's Hospital, Tel Aviv Medical Center
Principal Investigator: Spyros Sgouros, MD Birmingham Children's Hospital
  More Information

No publications provided

Responsible Party: Abhaya Kulkarni, Staff neurologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00652470     History of Changes
Other Study ID Numbers: 1000007601
Study First Received: March 31, 2008
Last Updated: September 6, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
infants
Hydrocephalus
Cerebrospinal Fluid Shunt
Ventriculostomy
neurosurgery

Additional relevant MeSH terms:
Hydrocephalus
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Intracranial Hypertension

ClinicalTrials.gov processed this record on April 16, 2014