HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants
ConditionHydrocephalus
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age1-104
SponsorUniversity of Utah
About this trial
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.
Eligibility criteria
Qualifiers
Corrected age <104 weeks and 0 days,
Child is ≥ 37 weeks post menstrual age,
Head circumference >98th percentile for corrected age with either bulging fontanelle or splayed sutures
Upgaze paresis/palsy (sundowning)
Disqualifiers
Hydrocephalus due to intraventricular hemorrhage in a child born before 37 weeks gestational age; OR
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)
Trial design
Treatments tested in this trial
- Endoscopic Third Ventriculostomy with Choroid Plexus Cauterization (ETV+CPC)
- Ventriculoperitoneal Shunt
Treatment groups
176 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Utah
Lead sponsor
University of Alabama at Birmingham
Collaborator
University of British Columbia
Collaborator
University of Pittsburgh
Collaborator
The Hospital for Sick Children
Collaborator
Seattle Children's Hospital
Collaborator
Vanderbilt University Medical Center
Collaborator
Washington University School of Medicine
Collaborator
Nationwide Children's Hospital
Collaborator
Johns Hopkins University
Collaborator
University of Calgary
Collaborator
University of Colorado, Denver
Collaborator
Children's Hospital Los Angeles
Collaborator
National Institutes of Health (NIH)
Collaborator
Hydrocephalus Association
Collaborator
Penn State University
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Baylor College of Medicine
Collaborator
University of Florida
Collaborator
Orlando Health, Inc.
Collaborator
Virginia Commonwealth University
Collaborator
Trustees of Indiana University
Collaborator
Source ClinicalTrials.gov