NCT00652470

A Study Comparing Two Treatments for Infants With Hydrocephalus

International Infant Hydrocephalus Study: A Multicentre, Prospective Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 182 (estimated)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 1 Day – 24 Months
• Healthy volunteers: Not accepted

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.

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).

Conditions

• Hydrocephalus

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2005-09-01
• Primary completion: 2018-05-01
• Completion: 2018-05-01
• First posted: 2008-04-03
• Last updated: 2018-09-10

Locations

22 sites across 16 countries: United States, Argentina, Brazil, Canada, Germany, Hungary, India, Israel, Italy, Netherlands, Poland, Russia, Serbia, Spain, Turkey (Türkiye), United Kingdom