Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Dallas, Texas 75235


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.


Study summary:

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).


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


Study is Available At:


Original ID:

1000007601


NCT ID:

NCT00652470


Secondary ID:


Study Acronym:


Brief Title:

A Study Comparing Two Treatments for Infants With Hydrocephalus


Official Title:

International Infant Hydrocephalus Study: A Multicentre, Prospective Study


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

N/A


Maximum Age:

24 Months


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

The Hospital for Sick Children


Oversight Authority:

Canada: Ethics Review Committee


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

182


Enrollment Type:

Anticipated


Overall Contact Information

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

Study Dates

Start Date:September 2005
Completion Date:May 1, 2018
Completion Type:Actual
Primary Completion Date:May 1, 2018
Primary Completion Type:Actual
Verification Date:September 2018
Last Changed Date:September 7, 2018
First Received Date:March 31, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Ventricular size and the existence of flow void (ETV group)assessed through radiological evaluation
Time Frame:3 years of age
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Complications such as CNS infection, focal neurological deficit, significant hemorrhage, seizures requiring medication
Time Frame:Duration of the Study
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Need for repeat radiological scans
Time Frame:Duration of the Study
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Hospitalization Time
Time Frame:5 years post-operation
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Incidence of failure of initial intervention
Time Frame:Duration of the Study
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Surgical Morbidity
Time Frame:Duration of the Study
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Number of Subsequent Hydrocephalus-Related Operations
Time Frame:Duration of the Study
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Health status outcome using the Hydrocephalus Outcome Questionnaire
Time Frame:At 5 years of Age
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Neurodevelopment as measured by the Denver Developmental Screening Test
Time Frame:Up to 3 years of Age
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Death
Time Frame:Duration of the Study
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Health Status Outcome as measured by the Health Utilities Index - 2
Time Frame:At 5 years of age
Safety Issues:False

Study Interventions

Intervention Type:Procedure
Name:Endoscopic Third Ventriculostomy
Description: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.
Arm Name:ETV
Intervention Type:Procedure
Name:CSF Shunt Insertion
Description: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.
Arm Name:CSF Shunt

Study Arms

Study Arm Type:Active Comparator
Arm Name:CSF Shunt
Study Arm Type:Active Comparator
Arm Name:ETV

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:The Hospital for Sick Children
Agency Class:Other
Agency Type:Collaborator
Agency Name:The International Study Group for Neuroendoscopy (ISGNE)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.