Actively Recruiting
Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants
Led by University of Utah · Updated on 2025-06-11
176
Participants Needed
21
Research Sites
13 weeks
Total Duration
On this page
Sponsors
U
University of Utah
Lead Sponsor
U
University of Alabama at Birmingham
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating two treatments for hydrocephalus in infants under two years old, a condition where fluid builds up in the brain. This study compares the traditional shunt procedure with a newer endoscopic approach combined with choroid plexus cauterization (ETV+CPC). The goal is to understand which treatment leads to better brain development and intellectual outcomes for babies with this condition. Participants will be randomly assigned to receive either the ETV+CPC procedure, which uses a camera to create an internal bypass and burns tissue producing cerebrospinal fluid, or a ventriculoperitoneal shunt, which places tubing to drain fluid from the brain to the abdomen. Both are performed as surgical procedures. The study leverages a network of pediatric neurosurgical centers to carry out this comparison. Families and researchers will monitor the child's development over 12 months after surgery using the Bayley Scale of Infant Development-IV to measure cognitive, language, and motor skills. Brain scans using diffusion MRI will assess white matter integrity and structural connectivity. This research aims to provide clear information to help families choose the best treatment for their child. Participation lasts at least one year following the surgical intervention.
CONDITIONS
Brief Title
HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Child is younger than 104 weeks corrected age (under 2 years old)
- Child is at least 37 weeks post menstrual age at birth
- Child has symptomatic hydrocephalus confirmed by MRI and clinical signs such as enlarged head circumference, bulging fontanelle, upgaze palsy, CSF leak, papilledema, tense fluid collections, vomiting, irritability, bradycardias, apneas, or elevated intracranial pressure
- No prior history of shunt insertion or endoscopic third ventriculostomy (ETV) procedure
You will not qualify if you...
- Hydrocephalus caused by intraventricular hemorrhage in babies born before 37 weeks gestation
- Brain anatomy unsuitable for ETV+CPC or anterior ventriculoperitoneal shunt due to specific MRI findings or lesions
- High risk of death within 12 months from underlying condition
- Hydrocephalus with loculated cerebrospinal fluid compartments
- Peritoneal cavity not suitable for shunt placement
- Active cerebrospinal fluid infection
- Hydranencephaly
- Need for additional intraventricular procedures beyond the initial permanent surgery for hydrocephalus
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery and immediate recovery period
Participants receive either the Endoscopic Third Ventriculostomy with Choroid Plexus Cauterization (ETV+CPC) procedure or the Ventriculoperitoneal Shunt procedure as treatment for hydrocephalus.
1 surgery visit and several immediate post-operative visits
Duration - Up to 12 months post surgery
Participants are monitored through follow-up visits to assess recovery and treatment outcomes up to 12 months after surgery.
Multiple follow-up visits during the 12 months
Trial Site Locations
Total: 21 locations
1
Children's of Alabama
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
Not Yet Recruiting
3
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
4
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
5
Yale University
New Haven, Connecticut, United States, 06520
Active, Not Recruiting
6
Wolfson Children's Hospital
Jacksonville, Florida, United States, 32207
Actively Recruiting
7
Arnold Palmer Hospital for Children
Orlando, Florida, United States, 32806
Actively Recruiting
8
Trustees of Indiana University
Indianapolis, Indiana, United States, 46202
Not Yet Recruiting
9
Johns Hopkins Children's Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
10
St. Louis Children's Hospital
St Louis, Missouri, United States, 63110
Actively Recruiting
11
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
12
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
13
The Pennsylvania State University
University Park, Pennsylvania, United States, 16802
Active, Not Recruiting
14
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States, 37232
Actively Recruiting
15
Texas Children's Hospital
Houston, Texas, United States, 77030
Actively Recruiting
16
Primary Children's Hospital
Salt Lake City, Utah, United States, 84118
Actively Recruiting
17
Virginia Commonwealth University
Richmond, Virginia, United States, 23284
Active, Not Recruiting
18
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
19
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8
Actively Recruiting
20
British Columbia Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Actively Recruiting
21
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Actively Recruiting
Research Team
N
Nichol Nunn
J
Jason Clawson
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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