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NCT04177914PHASE3Recruiting

HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants

University of Utah

Start Date

7/21/2020

Completion Date

8/31/2027

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.

Detailed Description

The ESTHI Trial is a multi-center randomized controlled trial (RCT) comparing endoscopic third ventriculostomy with choroid plexus cauterization (ETV+CPC) and shunt in infants with hydrocephalus. The study will leverage the infrastructure of the Hydrocephalus Clinical Research Network (HCRN), a committed group of 14 leading North American pediatric neurosurgical centers with a long track-record of successful collaborative clinical research and RCTs in hydrocephalus. Optimal cognitive outcome is the primary concern of families and will, therefore, be the primary outcome. Assessment of dMRI, a validated, non-invasive method of measuring white matter microstructural integrity and structural connectivity in the developing brain, will provide further insight into the developmental consequences of these two treatments. The results of the RCT will help families determine the optimal treatment of hydrocephalus for their child.

Eligibility Criteria

Age Range: No minimum to No maximum

Inclusion Criteria: 1. Corrected age \<104 weeks and 0 days, AND 2. Child is ≥ 37 weeks post menstrual age, AND 3. Child must have symptomatic hydrocephalus, defined as: Ventriculomegaly on MRI (frontal-occipital horn ratio (FOR) \>0.45, which approximates "moderate ventriculomegaly"), and at least one of the following: * Head circumference \>98th percentile for corrected age with either bulging fontanelle or splayed sutures * Upgaze paresis/palsy (sundowning) * CSF leak * Papilledema * Tense pseudomeningocele or tense fluid along a track * Vomiting or irritability, with no other attributable cause * Bradycardias or apneas, with no other attributable cause * Intracranial pressure (ICP) monitoring showing persistent elevation of pressure with or without plateau waves AND 4. No prior history of shunt insertion or endoscopic third ventriculostomy (ETV) procedure (previous temporization devices and/or external ventricular drains permissible) Exclusion Criteria: 1. Hydrocephalus due to intraventricular hemorrhage in a child born before 37 weeks gestational age; OR 2. Anatomy not suitable for ETV+CPC or anteriorly placed ventriculoperitoneal shunt defined as: * Moderate to severe prepontine adhesions on steady state free precession (SSFP) or T2 weighted fast (turbo) spin echo (FSE/TSE) MRI, which includes the following sequences: FIESTA, FIESTA-C, TrueFISP, CISS, Balanced FFE (bFFE), CUBE, SPACE, VISTA, IsoFSE, and 3D MVOX * Closure of one or both foramina of Monro * Thick floor of third ventricle (≥ 3mm) * Narrow third ventricle (\<5mm) * Presence of scalp, bone, or ventricular lesions that make placement of an anterior shunt impracticable; OR 3. Underlying condition with a high chance of mortality within 12 months; OR 4. Hydrocephalus with loculated CSF compartments; OR 5. Peritoneal cavity not suitable for distal shunt placement; OR 6. Active CSF infection; OR 7. Hydranencephaly; OR 8. Child requires an intraventricular procedure (e.g. endoscopic biopsy) in addition to the initial first-time permanent procedure for the treatment of hydrocephalus.

Interventions

PROCEDURE

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

DEVICE

Ventriculoperitoneal Shunt

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Conditions

Hydrocephalus

Locations

Children's of Alabama

Birmingham, Alabama 35233

United States

Phoenix Children's Hospital

Phoenix, Arizona 85016

United States

Children's Hospital of Los Angeles

Los Angeles, California 90027

United States

Children's Hospital Colorado

Aurora, Colorado 80045

United States

Yale University

New Haven, Connecticut 06520

United States

Wolfson Children's Hospital

Jacksonville, Florida 32207

United States

Arnold Palmer Hospital for Children

Orlando, Florida 32806

United States

Trustees of Indiana University

Indianapolis, Indiana 46202

United States

Johns Hopkins Children's Center

Baltimore, Maryland 21287

United States

St. Louis Children's Hospital

St Louis, Missouri 63110

United States

Nationwide Children's Hospital

Columbus, Ohio 43205

United States

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania 15224

United States

The Pennsylvania State University

University Park, Pennsylvania 16802

United States

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee 37232

United States

Texas Children's Hospital

Houston, Texas 77030

United States

Primary Children's Hospital

Salt Lake City, Utah 84118

United States

Virginia Commonwealth University

Richmond, Virginia 23284

United States

Seattle Children's Hospital

Seattle, Washington 98105

United States

Alberta Children's Hospital

Calgary, Alberta T3B 6A8

Canada

British Columbia Children's Hospital

Vancouver, British Columbia V6H 3V4

Canada

The Hospital for Sick Children

Toronto, Ontario M5G 1X8

Canada