A Study Comparing Two Treatments for Infants With Hydrocephalus

Hydrocephalus Clinical Trial

Official title:

International Infant Hydrocephalus Study: A Multicentre, Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00652470
• Other study ID #: 1000007601
• Status: Completed
• Phase: Phase 2
• Start date: September 2005
• Est. completion date: May 1, 2018

Study information

• Verified date: September 2018
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: May 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Hydrocephalus

Intervention

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 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.

Locations

Country	Name	City	State
Argentina	Nacional de Pediatria	Buenos Aires
Brazil	Biocor Instituto	Nova Lima
Brazil	UNIFESP	Sao Paulo
Canada	The Hospital for Sick Children	Toronto	Ontario
Germany	University Hospital Gießen and Marburg	Giessen
Hungary	University of Debrecen	Debrecen
India	Sanjay Gandhi Postgraduate Institute of Medical Sciences	Lucknow
India	All India Institute of Medical Sciences	New Delhi
Israel	Dana Children's Hospital, Tel Aviv Medical Center	Tel Aviv
Italy	Giannina Gaslini Hospital	Genova
Italy	Catholic University Medical School Rome	Rome
Netherlands	University Medical Center St Radboud	Nijmegen
Poland	Medical University of Silesia	Katowice
Poland	Polish Mother's Memorial Hospital	Lodz
Poland	Children's Memorial Health Institute	Warsaw
Russian Federation	Burdenko Neurosurgical Institute	Moscow
Serbia	Institute for Neurosurgery	Belgrade
Spain	Hospital Sant Joan de Deu	Barcelona
Turkey	Hacettepe University Hospital	Ankara
United Kingdom	Birmingham Children's Hospital	Birmingham
United Kingdom	Alder Hey Children's Hospital	Liverpool
United States	Children's Medical Center of Dallas	Dallas	Texas

Sponsors (3)

Lead Sponsor	Collaborator
The Hospital for Sick Children	The International Society for Pediatric Neurosurgery, The International Study Group for Neuroendoscopy (ISGNE)

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Canada,  Germany,  Hungary,  India,  Israel,  Italy,  Netherlands,  Poland,  Russian Federation,  Serbia,  Spain,  Turkey,  United Kingdom, 

Outcome

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