A Study Comparing Two Treatments for Infants With Hydrocephalus

Hydrocephalus Clinical Trial

Official title: International Infant Hydrocephalus Study: A Multicentre, Prospective Study

Status Completed

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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Hydrocephalus

• NCT number: NCT00652470
• Study type: Interventional
• Source: The Hospital for Sick Children
• Status: Completed
• Phase: Phase 2
• Start date: September 2005
• Completion date: May 1, 2018