Ventricular Size Involvement in Neuropsychological Outcomes in Pediatric Hydrocephalus (VINOH)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
Hydrocephalus Association Mentored Young Investigator Award
Information provided by (Responsible Party):
richard holubkov, University of Utah
ClinicalTrials.gov Identifier:
NCT01797627
First received: June 8, 2012
Last updated: January 7, 2016
Last verified: January 2016
  Purpose
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.

Condition
Hydrocephalus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ventricular Size Involvement in Neuropsychological Outcomes in Pediatric Hydrocephalus (VINOH)

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Association between ventricle size and neuropsychological outcome [ Time Frame: 6 months after initial surgical treatment for hydrocephalus ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Quality of life [ Time Frame: 6 months after initial surgical treatment for hydrocephalus ] [ Designated as safety issue: No ]
    The Hydrocephalus Outcome Questionnaire (HOQ) will be administered at approximately 6 months. The HOQ is a validated measure of quality of life specific to the pediatric hydrocephalus population.

  • Academic Performance [ Time Frame: 6 months after initial surgical treatment for hydrocephalus ] [ Designated as safety issue: No ]
    Parents will be asked to provide a picture of their child's current academic performance. If available, the child's most recent grade point average (GPA) will be obtained.

  • Presence of additional required hydrocephalus related surgeries [ Time Frame: 6 months after initial surgical treatment for hydrocephalus ] [ Designated as safety issue: No ]
    Shunt and ETV revisions or infections will be examined for any correlations with cognitive neuropsychological testing at 6 months from the initial surgical intervention.


Estimated Enrollment: 62
Study Start Date: August 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
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 study design (possible confounding factors), varying study populations of hydrocephalus, and conflicting evidence. If the association is proven then aggressive strategies must be developed to maximally decrease ventricular size in these children to preserve long-term cognitive functioning. However, if the association is disproven then previous reservations for procedures such as Endoscopic Third Ventriculostomy (ETV) or higher-resistance shunting to prevent overdrainage complications will be further minimized. Either finding has a major potential to further improve the quality of life in our pediatric hydrocephalus patients. This study is unique as it will include pediatric patients presenting with hydrocephalus from a wide range of etiologies. This study is also unique in that we propose to conduct a brief pre-operative neuropsychological examination to act as internal controls along with the outcomes obtained at a more extensive neuropsychological examination at six months after initial hydrocephalus treatment surgery.
  Eligibility

Ages Eligible for Study:   5 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric, school-aged patients presenting with a first time diagnosis of hydrocephalus.
Criteria

Inclusion Criteria: 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 Criteria: 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01797627

Locations
United States, Alabama
Children's Hospital of Alabama, University of Alabama
Birmingham, Alabama, United States, 35233
United States, Missouri
St. Louis Children's Hospital
St. Louis, Missouri, United States, 63110
United States, Pennsylvania
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
United States, Tennessee
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States, 37232
United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
United States, Utah
Primary Children's Hospital
Salt Lake City, Utah, United States, 84118
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Canada, Ontario
Sick Children's Hospital
Toronto, Ontario, Canada
Sponsors and Collaborators
University of Utah
National Institute of Neurological Disorders and Stroke (NINDS)
Hydrocephalus Association Mentored Young Investigator Award
Investigators
Study Chair: Jay Riva-Cambrin, MD, MSc Alberta Children's Hospital
Principal Investigator: Richard Holubkov, Ph.D. University of Utah
  More Information

Additional Information:
No publications provided

Responsible Party: richard holubkov, Ph.D., University of Utah
ClinicalTrials.gov Identifier: NCT01797627     History of Changes
Other Study ID Numbers: 49237  1RC1NS068943-01  HCRN 006 
Study First Received: June 8, 2012
Last Updated: January 7, 2016
Health Authority: United States: Institutional Review Board
Canada: Research Ethics Board

Keywords provided by University of Utah:
Pediatric Hydrocephalus
Ventricular Size
Neuropsychological Outcomes
Quality of Life

Additional relevant MeSH terms:
Hydrocephalus
Brain Diseases
Central Nervous System Diseases
Intracranial Hypertension
Nervous System Diseases

ClinicalTrials.gov processed this record on February 09, 2016