NCT04177914 · University of Utah
HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants
(ESTHI)
What this study is about
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.
View original scientific 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.
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.
Primary outcome measures
Bayley Scale of Infant Development-IV (Bayley-IV) Cognitive Scale score
Time frame: 12 months post randomized surgical intervention
The primary objective is to determine, in infants \<104 weeks corrected age, with hydrocephalus requiring treatment at tertiary care pediatric neurosurgery centers in North America, if treatment with ETV+CPC compared to shunt results in non-inferior cognitive outcome at 12 months from surgery, as measured by Bayley-IV Cognitive Scale score with a non-inferiority margin of 1.5. Scaled scores range from 1-19. Higher scores indicate better outcomes. Scores will also be obtained at 3 and 5 years of age.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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)
- 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) Exclusio
Where
- Birmingham, Alabama
- Phoenix, Arizona
- Los Angeles, California
- Aurora, Colorado
- New Haven, Connecticut
- Jacksonville, Florida
- Orlando, Florida
- Indianapolis, Indiana
- Baltimore, Maryland
- St Louis, Missouri
- Columbus, Ohio
- Pittsburgh, Pennsylvania
And 6 more locations — see the full list below.
Collaborators
University of Alabama at Birmingham, University of British Columbia, University of Pittsburgh, The Hospital for Sick Children, Seattle Children's Hospital, Vanderbilt University Medical Center, Washington University School of Medicine, Nationwide Children's Hospital, Johns Hopkins University, University of Calgary, University of Colorado, Denver, Children's Hospital Los Angeles, National Institutes of Health (NIH), Hydrocephalus Association, Penn State University, National Institute of Neurological Disorders and Stroke (NINDS), Baylor College of Medicine, University of Florida, Orlando Health, Inc., Virginia Commonwealth University, Trustees of Indiana University
Related conditions & keywords
Frequently asked questions
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Data: ClinicalTrials.gov · synced Jun 11, 2025 · Source of record for eligibility and locations