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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University of Utah
Sponsor:
Collaborators:
Hydrocephalus Association Mentored Young Investigator Award
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT01797627
First received: June 8, 2012
Last updated: February 20, 2013
Last verified: February 2013

June 8, 2012
February 20, 2013
August 2011
April 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01797627 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
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Ventricular Size Involvement in Neuropsychological Outcomes in Pediatric Hydrocephalus
Ventricular Size Involvement in Neuropsychological Outcomes in Pediatric Hydrocephalus (VINOH)

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Pediatric, school-aged patients presenting with a first time diagnosis of hydrocephalus.

Hydrocephalus
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
62
November 2014
April 2014   (final data collection date for primary outcome measure)

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.
Both
5 Years to 17 Years
No
Contact: Marcie Langley 801-662-5364 marcie.langley@hsc.utah.edu
United States,   Canada
 
NCT01797627
49237, 1RC1NS068943-01, HCRN 006
No
University of Utah
University of Utah
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • Hydrocephalus Association Mentored Young Investigator Award
Study Chair: Jay Riva-Cambrin, MD, MSc Primary Children's Hospital
Principal Investigator: Kulkarni Abhaya, MD, PhD Sick Children's Hospital
Principal Investigator: Curtis Rozzelle, MD Children's Hospital of Alabama
Principal Investigator: William E Whitehead, MD, MPH Texas Children's Hospital
Principal Investigator: Samuel R Browd, PhD Seattle Children's Hospital
Principal Investigator: Tamara D Simon, MD, MSPH Seattle Children's Hospital
Principal Investigator: David Limbrick, MD, PhD St. Louis Children's Hospital
Principal Investigator: Mandeep S Tamber, MD, PhD Children's Hospital of Pittsburgh of UPMC
Principal Investigator: John Kestle, MD Chair, Hydrocephalus Clinical Research Network
University of Utah
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP