Status:
COMPLETED
Ventricular Size Involvement in Neuropsychological Outcomes in Pediatric Hydrocephalus
Lead Sponsor:
University of Utah
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Hydrocephalus Association
Conditions:
Hydrocephalus
Eligibility:
All Genders
5-17 years
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 larg...
Detailed Description
The current literature is inconclusive regarding the direct association between large ventricle size and poorer cognitive outcomes. This uncertainty stems from relatively few studies, problems with st...
Eligibility Criteria
Inclusion
- Patients will be eligible for enrollment if they:
- 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.
Exclusion
- Patients will be ineligible for enrollment if ANY of the following is true or anticipated:
- 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.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT01797627
Start Date
August 1 2011
End Date
August 1 2016
Last Update
January 29 2020
Active Locations (8)
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1
Children's Hospital of Alabama, University of Alabama
Birmingham, Alabama, United States, 35233
2
St. Louis Children's Hospital
St Louis, Missouri, United States, 63110
3
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
4
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States, 37232