HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants

Description

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.

Conditions

Hydrocephalus

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Study Overview

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Study Details

Study overview

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.

Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants

HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants

Condition
Hydrocephalus
Intervention / Treatment

-

Contacts and Locations

Birmingham

Children's of Alabama, Birmingham, Alabama, United States, 35233

Los Angeles

Children's Hospital of Los Angeles, Los Angeles, California, United States, 90027

Aurora

Children's Hospital Colorado, Aurora, Colorado, United States, 80045

New Haven

Yale University, New Haven, Connecticut, United States, 06520

Jacksonville

Wolfson Children's Hospital, Jacksonville, Florida, United States, 32207

Orlando

Arnold Palmer Hospital for Children, Orlando, Florida, United States, 32806

Baltimore

Johns Hopkins Children's Center, Baltimore, Maryland, United States, 21287

Saint Louis

St. Louis Children's Hospital, Saint Louis, Missouri, United States, 63110

Columbus

Nationwide Children's Hospital, Columbus, Ohio, United States, 43205

Pittsburgh

Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States, 15224

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Corrected age \<104 weeks and 0 days,
  • 2. Child is ≥ 37 weeks post menstrual age,
  • 3. Child must have symptomatic hydrocephalus, defined as:
  • * 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
  • 4. No prior history of shunt insertion or endoscopic third ventriculostomy (ETV) procedure (previous temporization devices and/or external ventricular drains permissible)
  • 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.

Ages Eligible for Study

1 Day to 104 Weeks

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Utah,

John Kestle, MD, STUDY_CHAIR, University of Utah

Abhaya Kulkarni, MD, PRINCIPAL_INVESTIGATOR, University of Toronto

David Limbrick, MD, PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

Richard Holubkov, PhD, PRINCIPAL_INVESTIGATOR, University of Utah

Study Record Dates

2027-08-31