Ventricular Size Involvement in Neuropsychological Outcomes in Pediatric Hydrocephalus
VINOH
3 other identifiers
observational
78
2 countries
8
Brief Summary
This multicenter, prospective study of children with hydrocephalus will examine whether or not ventricle size is associated with poor cognitive outcomes. It is expected that results will indicate larger ventricular size at 6 months after surgery for the initial treatment of hydrocephalus will relate to poorer cognitive outcomes. This study is being conducted by the Hydrocephalus Clinical Research Network (HCRN), a network established to conduct multi-institutional clinical trials on pediatric hydrocephalus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2011
Longer than P75 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 8, 2012
CompletedFirst Posted
Study publicly available on registry
February 22, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedJanuary 29, 2020
January 1, 2020
4.9 years
June 8, 2012
January 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Association between ventricle size and neuropsychological outcome
Ventricle size, measured as fronto-occipital horn ratio (FOR), as well as neuropsychological outcomes at 6 months post-surgical intervention for initial treatment of hydrocephalus will be compared.
6 months after initial surgical treatment for hydrocephalus
Secondary Outcomes (3)
Quality of life
6 months after initial surgical treatment for hydrocephalus
Academic Performance
6 months after initial surgical treatment for hydrocephalus
Presence of additional required hydrocephalus related surgeries
6 months after initial surgical treatment for hydrocephalus
Eligibility Criteria
Pediatric, school-aged patients presenting with a first time diagnosis of hydrocephalus.
You may qualify if:
- are 5 years of age or older; and
- have been newly diagnosed with hydrocephalus to be managed surgically with either a cerebrospinal fluid (CSF) shunt or an ETV; and
- have one of the following etiologies for hydrocephalus: aqueductal stenosis, supratentorial and posterior fossa tumors both benign and malignant, post-traumatic, myelomeningocele, tectal gliomas, post-infectious, and following spontaneous intraventricular hemorrhage (IVH). Malignant tumors have been included as the neuropsychological deficits secondary to adjuvant chemotherapy and radiation have not been demonstrated within the proposed study's 6 month window.
You may not qualify if:
- present with a Glasgow Coma Scale (GCS) score of less than 14/15, cerebellar mutism, or cognitive deficits so severe as to make neuropsychological testing impossible; OR
- have etiologies of diffuse intrinsic pontine glioma, atypical teratoid rhabdoid tumor, or any tumor with cerebral or spinal metastases (these patients' clinical course and survival are highly unpredictable); OR
- are not expected to survive for 6 months; OR
- are unable or unwilling to participate in the study and with the neuropsychological exam; OR
- due to limitations of neuropsychological testing, blind and deaf children will be excluded. Children for whom English is not their primary language will be included if they have attended 1 or more years of English language based schooling.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Utahlead
- National Institute of Neurological Disorders and Stroke (NINDS)collaborator
- Hydrocephalus Associationcollaborator
Study Sites (8)
Children's Hospital of Alabama, University of Alabama
Birmingham, Alabama, 35233, United States
St. Louis Children's Hospital
St Louis, Missouri, 63110, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224, 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
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Sick Children's Hospital
Toronto, Ontario, Canada
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jay Riva-Cambrin, MD, MSc
Alberta Children's Hospital
- PRINCIPAL INVESTIGATOR
Richard Holubkov, Ph.D.
University of Utah
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ph.D.
Study Record Dates
First Submitted
June 8, 2012
First Posted
February 22, 2013
Study Start
August 1, 2011
Primary Completion
July 1, 2016
Study Completion
August 1, 2016
Last Updated
January 29, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share