Clinical Trial: A Study Comparing Two Treatments for Infants With Hydrocephalus

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief 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 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).

Sponsor: The Hospital for Sick Children

Current Primary Outcome: Health Status Outcome as measured by the Health Utilities Index - 2 [ Time Frame: At 5 years of age ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: The Hospital for Sick Children

Dates:
Date Received: March 31, 2008
Date Started: September 2005
Date Completion: December 2019
Last Updated: April 24, 2017
Last Verified: April 2017