A Study Comparing Two Treatments for Infants With Hydrocephalus - Full Text View

Sponsors and Collaborators:	The Hospital for Sick Children The International Study Group for Neuroendoscopy (ISGNE) The International Society for Pediatric Neurosurgery (ISPN)
Information provided by:	The Hospital for Sick Children
ClinicalTrials.gov Identifier:	NCT00652470

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 II

MedlinePlus related topics: Endoscopy Hydrocephalus

Drug Information available for: Baysilon Polydimethylsiloxane

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	International Infant Hydrocephalus Study: A Multicentre, Prospective Study

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 2011
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
ETV: Active Comparator	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.
CSF Shunt: Active Comparator	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 (ISPN)

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

Responsible Party:	The Hospital for Sick Children ( Abhaya Kulkarni )
Study ID Numbers:	1000007601
Study First Received:	March 31, 2008
Last Updated:	April 3, 2008
ClinicalTrials.gov Identifier:	NCT00652470
Health Authority:	Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:

infants
Hydrocephalus
Cerebrospinal Fluid Shunt
Ventriculostomy
neurosurgery

Study placed in the following topic categories:

Pseudotumor cerebri
Pseudotumor Cerebri
Infant, Newborn, Diseases
Central Nervous System Diseases

Hydrocephalus
Brain Diseases
Intracranial Hypertension
Hypertension

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009