Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants

Status: Recruiting
Location: See all (21) locations...
Intervention Type: Procedure, Device
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 day
Maximum Age: 2
Healthy Volunteers: f
View:

• 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)

Locations
United States
Alabama
Children's of Alabama
RECRUITING
Birmingham
Arizona
Phoenix Children's Hospital
NOT_YET_RECRUITING
Phoenix
California
Children's Hospital of Los Angeles
RECRUITING
Los Angeles
Colorado
Children's Hospital Colorado
RECRUITING
Aurora
Connecticut
Yale University
ACTIVE_NOT_RECRUITING
New Haven
Florida
Wolfson Children's Hospital
RECRUITING
Jacksonville
Arnold Palmer Hospital for Children
RECRUITING
Orlando
Indiana
Trustees of Indiana University
NOT_YET_RECRUITING
Indianapolis
Maryland
Johns Hopkins Children's Center
RECRUITING
Baltimore
Missouri
St. Louis Children's Hospital
RECRUITING
St Louis
Ohio
Nationwide Children's Hospital
RECRUITING
Columbus
Pennsylvania
Children's Hospital of Pittsburgh of UPMC
RECRUITING
Pittsburgh
The Pennsylvania State University
ACTIVE_NOT_RECRUITING
University Park
Tennessee
Monroe Carell Jr. Children's Hospital at Vanderbilt
RECRUITING
Nashville
Texas
Texas Children's Hospital
RECRUITING
Houston
Utah
Primary Children's Hospital
RECRUITING
Salt Lake City
Virginia
Virginia Commonwealth University
ACTIVE_NOT_RECRUITING
Richmond
Washington
Seattle Children's Hospital
RECRUITING
Seattle
Other Locations
Canada
Alberta Children's Hospital
RECRUITING
Calgary
The Hospital for Sick Children
RECRUITING
Toronto
British Columbia Children's Hospital
RECRUITING
Vancouver
Contact Information
Primary
Nichol Nunn
nichol.nunn@hsc.utah.edu
801-458-6593
Backup
Jason Clawson
jason.clawson@hsc.utah.edu
Time Frame
Start Date: 2020-07-21
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 176
Treatments
Active_comparator: ETV+CPC
Subjects randomized to this arm will undergo an ETV+CPC procedure for treatment of Hydrocephalus
Active_comparator: Ventriculoperitoneal Shunt
Subjects randomized to this arm will undergo a Ventriculoperitoneal Shunt procedure for treatment of Hydrocephalus
Related Therapeutic Areas
Sponsors
Collaborators: Washington University School of Medicine, Nationwide Children's Hospital, University of Florida, Vanderbilt University Medical Center, Seattle Children's Hospital, University of British Columbia, University of Pittsburgh, Trustees of Indiana University, University of Calgary, National Institute of Neurological Disorders and Stroke (NINDS), Virginia Commonwealth University, Hydrocephalus Association, Children's Hospital Los Angeles, Johns Hopkins University, National Institutes of Health (NIH), University of Alabama at Birmingham, Orlando Health, Inc., Penn State University, Baylor College of Medicine, University of Colorado, Denver, The Hospital for Sick Children
Leads: University of Utah

This content was sourced from clinicaltrials.gov