Clinical Trial: Ventricular Size Involvement in Neuropsychological Outcomes in Pediatric Hydrocephalus

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: Ventricular Size Involvement in Neuropsychological Outcomes in Pediatric Hydrocephalus (VINOH)

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.

Detailed Summary: 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.
Sponsor: University of Utah

Current Primary Outcome: Association between ventricle size and neuropsychological outcome [ Time Frame: 6 months after initial surgical treatment for hydrocephalus ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Quality of life [ Time Frame: 6 months after initial surgical treatment for hydrocephalus ]
    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 ]
    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 ]
    Shunt and ETV revisions or infections will be examined for any correlations with cognitive neuropsychological testing at 6 months from the initial surgical intervention.


Original Secondary Outcome: Same as current

Information By: University of Utah

Dates:
Date Received: June 8, 2012
Date Started: August 2011
Date Completion: December 2017
Last Updated: November 18, 2016
Last Verified: November 2016