Clinical Trial

HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants

Study acronym: ESTHI
Recruiting Phase 3
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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.
Protocol Amendment History 12 amendments
This ClinicalTrials.gov record has been amended 12 times since 2019-11-22; most recent amendment 2025-06-05.
Status change: Not Yet Recruiting → Recruiting 2020-09-14
Trial Details
NCT Number NCT04177914
Lead Sponsor University of Utah
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
Conditions Hydrocephalus
Enrollment 176 participants
Start Date 2020-07-21
Primary Completion 2027-05-30 (estimated)
Study Completion 2027-08-31 (estimated)
Updated on ClinicalTrials.gov 2025-06-11