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RECRUITING
NCT04177914
PHASE3

HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants

Sponsor: University of Utah

View on ClinicalTrials.gov

Summary

Hydrocephalus is a potentially debilitating neurological condition that primarily affects babies under a year of age and has traditionally been treated by inserting a shunt between the brain and the abdomen. A newer endoscopic procedure offers hope of shunt- free treatment that may reduce complications over a child's life, but it is not clear if the endoscopic procedure results in similar intellectual outcome as shunt. Therefore, the investigators propose a randomized trial to compare intellectual outcome and brain structural integrity between these two treatments, to help families make the best treatment decision for their baby.

Official title: Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants

Key Details

Gender

All

Age Range

1 Day - 104 Weeks

Study Type

INTERVENTIONAL

Enrollment

176

Start Date

2020-07-21

Completion Date

2027-08-31

Last Updated

2025-06-11

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

Endoscopic Third Ventriculostomy with Choroid Plexus Cauterization (ETV+CPC)

Since the early 1990s, ETV has become the main alternative to shunting for hydrocephalus. This procedure involves placing an endoscopic camera into the ventricles of the brain and creating a hole in the floor of the third ventricle to act as an internal bypass for obstructed CSF. The cauterization of choroid plexus (CPC) involves the use of a device to burn or cauterize tissue from the choroid plexus. The choroid plexus of the brain exists in the lateral ventricles, the third ventricle, and the fourth ventricle. Its main role is the production of CSF. The success of ETV alone is poor in infants, but when combined with CPC, improved results have been observed and ETV+CPC has become a safe viable option for these children.

DEVICE

Ventriculoperitoneal Shunt

The most common treatment for hydrocephalus has been the insertion of a ventriculoperitoneal shunt, which has been in popular use for over 50 years. This consists of silastic tubing attached to a valve mechanism that runs subcutaneously from the head to the abdomen. It is one of the most common procedures performed by pediatric neurosurgeons.

Locations (21)

Children's of Alabama

Birmingham, Alabama, United States

Phoenix Children's Hospital

Phoenix, Arizona, United States

Children's Hospital of Los Angeles

Los Angeles, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Yale University

New Haven, Connecticut, United States

Wolfson Children's Hospital

Jacksonville, Florida, United States

Arnold Palmer Hospital for Children

Orlando, Florida, United States

Trustees of Indiana University

Indianapolis, Indiana, United States

Johns Hopkins Children's Center

Baltimore, Maryland, United States

St. Louis Children's Hospital

St Louis, Missouri, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, United States

The Pennsylvania State University

University Park, Pennsylvania, United States

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, United States

Texas Children's Hospital

Houston, Texas, United States

Primary Children's Hospital

Salt Lake City, Utah, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Seattle Children's Hospital

Seattle, Washington, United States

Alberta Children's Hospital

Calgary, Alberta, Canada

British Columbia Children's Hospital

Vancouver, British Columbia, Canada

The Hospital for Sick Children

Toronto, Ontario, Canada