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A Study Comparing Two Treatments for Infants With Hydrocephalus

NCT00652470 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2018-09-10

No results posted yet for this study

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.

Conditions

  • Hydrocephalus

Interventions

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.

Sponsors & Collaborators

  • The International Study Group for Neuroendoscopy (ISGNE)

    collaborator UNKNOWN

  • The International Society for Pediatric Neurosurgery

    collaborator OTHER

  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Abhaya Kulkarni, MD · The Hospital for Sick Children, Toronto Canada

  • Shlomi Constantini, MD · Dana Children's Hospital, Tel Aviv Medical Center

  • Spyros Sgouros, MD · Birmingham Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2018-05-01
Completion
2018-05-01

Countries

  • United States
  • Argentina
  • Brazil
  • Canada
  • Germany
  • Hungary
  • India
  • Israel
  • Italy
  • Netherlands
  • Poland
  • Russia
  • Serbia
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00652470 on ClinicalTrials.gov