Actively Recruiting
HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants
Led by University of Utah · Updated on 2025-06-11
176
Participants Needed
21
Research Sites
371 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
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.
CONDITIONS
Official Title
HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Corrected age less than 104 weeks (about 2 years)
- Child is at least 37 weeks post menstrual age
- Child has symptomatic hydrocephalus defined by ventriculomegaly on MRI and at least one related symptom like large head size, bulging fontanelle, eye movement issues, CSF leak, papilledema, tense fluid collections, vomiting, irritability, bradycardia, apnea, or elevated intracranial pressure
- No prior shunt insertion or endoscopic third ventriculostomy (ETV) procedure (temporary devices or external drains allowed)
You will not qualify if you...
- Hydrocephalus caused by intraventricular hemorrhage in a child born before 37 weeks gestation
- Brain anatomy unsuitable for ETV+CPC or anterior shunt placement due to moderate to severe adhesions, closed foramina of Monro, thick or narrow third ventricle, or lesions preventing shunt placement
- Underlying condition with high risk of death within 12 months
- Hydrocephalus with loculated cerebrospinal fluid compartments
- Peritoneal cavity unsuitable for shunt placement
- Active cerebrospinal fluid infection
- Hydranencephaly
- Need for additional intraventricular procedures beyond the first permanent treatment for hydrocephalus
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
J
Jason Clawson
CONTACT
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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