RECRUITING

HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants

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Conditions

HydrocephalusInfantsVentriculoperitoneal ShuntETV+CPCendoscopic third ventriculostomychoroid plexus cauterization

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants

Quick Facts

Study Start:2020-07-21
Study Completion:2027-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04177914

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Day to 104 Weeks
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Corrected age \<104 weeks and 0 days,
  2. 2. Child is ≥ 37 weeks post menstrual age,
  3. 3. Child must have symptomatic hydrocephalus, defined as:
  4. * Head circumference \>98th percentile for corrected age with either bulging fontanelle or splayed sutures
  5. * Upgaze paresis/palsy (sundowning)
  6. * CSF leak
  7. * Papilledema
  8. * Tense pseudomeningocele or tense fluid along a track
  9. * Vomiting or irritability, with no other attributable cause
  10. * Bradycardias or apneas, with no other attributable cause
  11. * Intracranial pressure (ICP) monitoring showing persistent elevation of pressure with or without plateau waves
  12. 4. No prior history of shunt insertion or endoscopic third ventriculostomy (ETV) procedure (previous temporization devices and/or external ventricular drains permissible)
  1. 1. Hydrocephalus due to intraventricular hemorrhage in a child born before 37 weeks gestational age; OR
  2. 2. Anatomy not suitable for ETV+CPC or anteriorly placed ventriculoperitoneal shunt defined as:
  3. * 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
  4. * Closure of one or both foramina of Monro
  5. * Thick floor of third ventricle (≥ 3mm)
  6. * Narrow third ventricle (\<5mm)
  7. * Presence of scalp, bone, or ventricular lesions that make placement of an anterior shunt impracticable; OR
  8. 3. Underlying condition with a high chance of mortality within 12 months; OR
  9. 4. Hydrocephalus with loculated CSF compartments; OR
  10. 5. Peritoneal cavity not suitable for distal shunt placement; OR
  11. 6. Active CSF infection; OR
  12. 7. Hydranencephaly; OR
  13. 8. Child requires an intraventricular procedure (e.g. endoscopic biopsy) in addition to the initial first-time permanent procedure for the treatment of hydrocephalus.

Contacts and Locations

Study Contact

Nichol Nunn
CONTACT
801-458-6593
nichol.nunn@hsc.utah.edu
Jason Clawson
CONTACT
jason.clawson@hsc.utah.edu

Principal Investigator

John Kestle, MD
STUDY_CHAIR
University of Utah
Abhaya Kulkarni, MD
PRINCIPAL_INVESTIGATOR
University of Toronto
David Limbrick, MD
PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Richard Holubkov, PhD
PRINCIPAL_INVESTIGATOR
University of Utah

Study Locations (Sites)

Children's of Alabama
Birmingham, Alabama, 35233
United States
Children's Hospital of Los Angeles
Los Angeles, California, 90027
United States
Children's Hospital Colorado
Aurora, Colorado, 80045
United States
Yale University
New Haven, Connecticut, 06520
United States
Wolfson Children's Hospital
Jacksonville, Florida, 32207
United States
Arnold Palmer Hospital for Children
Orlando, Florida, 32806
United States
Johns Hopkins Children's Center
Baltimore, Maryland, 21287
United States
St. Louis Children's Hospital
Saint Louis, Missouri, 63110
United States
Nationwide Children's Hospital
Columbus, Ohio, 43205
United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
United States
The Pennsylvania State University
University Park, Pennsylvania, 16802
United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
United States
Texas Children's Hospital
Houston, Texas, 77030
United States
Primary Children's Hospital
Salt Lake City, Utah, 84118
United States
Virginia Commonwealth University
Richmond, Virginia, 23284
United States
Seattle Children's Hospital
Seattle, Washington, 98105
United States

Collaborators and Investigators

Sponsor: University of Utah

  • John Kestle, MD, STUDY_CHAIR, University of Utah
  • Abhaya Kulkarni, MD, PRINCIPAL_INVESTIGATOR, University of Toronto
  • David Limbrick, MD, PRINCIPAL_INVESTIGATOR, Washington University School of Medicine
  • Richard Holubkov, PhD, PRINCIPAL_INVESTIGATOR, University of Utah

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-07-21
Study Completion Date2027-08-31

Study Record Updates

Study Start Date2020-07-21
Study Completion Date2027-08-31

Terms related to this study

Keywords Provided by Researchers

  • Hydrocephalus
  • Infants
  • Ventriculoperitoneal Shunt
  • ETV+CPC
  • endoscopic third ventriculostomy
  • choroid plexus cauterization

Additional Relevant MeSH Terms

  • Hydrocephalus