HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants

Recruiting now · Phase 3

Conditions studied: Hydrocephalus

In brief

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.

Key facts

Study ID

NCT04177914

Run by

University of Utah

People needed

176

Starts

2020-07-21

Expected to finish

2027-08-31

Last updated by the study team

2025-06-11

Who can join

Age: 0 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Corrected age <104 weeks and 0 days,
• AND
• Child is ≥ 37 weeks post menstrual age,
• AND
• 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
• No prior history of shunt insertion or endoscopic third ventriculostomy (ETV) procedure (previous temporization devices and/or external ventricular drains permissible)

You may not qualify if…

• Hydrocephalus due to intraventricular hemorrhage in a child born before 37 weeks gestational age; OR
• 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
• Underlying condition with a high chance of mortality within 12 months; OR
• Hydrocephalus with loculated CSF compartments; OR
• Peritoneal cavity not suitable for distal shunt placement; OR
• Active CSF infection; OR
• Hydranencephaly; OR
• Child requires an intraventricular procedure (e.g. endoscopic biopsy) in addition to the initial first-time permanent procedure for the treatment of hydrocephalus.

Where it is running

• The Hospital for Sick Children — Toronto, Ontario, Canada (enrolling)
• Primary Children's Hospital — Salt Lake City, Utah, United States (enrolling)
• Seattle Children's Hospital — Seattle, Washington, United States (enrolling)
• Alberta Children's Hospital — Calgary, Alberta, Canada (enrolling)
• British Columbia Children's Hospital — Vancouver, British Columbia, Canada (enrolling)
• Children's of Alabama — Birmingham, Alabama, United States (enrolling)
• Children's Hospital of Los Angeles — Los Angeles, California, United States (enrolling)
• Children's Hospital Colorado — Aurora, Colorado, United States (enrolling)
• Wolfson Children's Hospital — Jacksonville, Florida, United States (enrolling)
• Arnold Palmer Hospital for Children — Orlando, Florida, United States (enrolling)
• Johns Hopkins Children's Center — Baltimore, Maryland, United States (enrolling)
• St. Louis Children's Hospital — St Louis, Missouri, United States (enrolling)
• Nationwide Children's Hospital — Columbus, Ohio, United States (enrolling)
• Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States (enrolling)
• Monroe Carell Jr. Children's Hospital at Vanderbilt — Nashville, Tennessee, United States (enrolling)
• Texas Children's Hospital — Houston, Texas, United States (enrolling)
• Phoenix Children's Hospital — Phoenix, Arizona, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• Trustees of Indiana University — Indianapolis, Indiana, United States
• Yale University — New Haven, Connecticut, United States
• The Pennsylvania State University — University Park, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.