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

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.

Study Overview

• Status: Completed
• Conditions: Hydrocephalus

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.

• Study Type: Observational
• Enrollment (Actual): 78

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • Sick Children's Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Children's Hospital of Alabama, University of Alabama
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • St. Louis Children's Hospital
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • Children's Hospital of Pittsburgh of UPMC
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Monroe Carell Jr. Children's Hospital at Vanderbilt
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital
  • Utah
    • Salt Lake City, Utah, United States, 84118
      • Primary Children's Hospital
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	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.	6 months after initial surgical treatment for hydrocephalus
Academic Performance	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.	6 months after initial surgical treatment for hydrocephalus
Presence of additional required hydrocephalus related surgeries	Shunt and ETV revisions or infections will be examined for any correlations with cognitive neuropsychological testing at 6 months from the initial surgical intervention.	6 months after initial surgical treatment for hydrocephalus

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS); Hydrocephalus Association
• Investigators: Study Chair: Jay Riva-Cambrin, MD, MSc, Alberta Children's Hospital

Publications and helpful links

Helpful Links

• Hydrocephalus Clinical Research Network website

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2011
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: June 8, 2012
• First Submitted That Met QC Criteria: February 20, 2013
• First Posted (Estimate): February 22, 2013

Study Record Updates

• Last Update Posted (Actual): January 29, 2020
• Last Update Submitted That Met QC Criteria: January 27, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Quality of Life; Pediatric Hydrocephalus; Ventricular Size; Neuropsychological Outcomes
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hydrocephalus
• Other Study ID Numbers: 49237; 1RC1NS068943-01 (U.S. NIH Grant/Contract); HCRN 006 (Other Identifier: HCRN Protocol Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No