VINOH: Ventricular Size Involvement in Neuropsychological Outcomes in Pediatric Hydrocephalus

Sponsor

University of Utah (Other)

Overall Status

Completed

CT.gov ID

NCT01797627

Collaborator

National Institute of Neurological Disorders and Stroke (NINDS) (NIH), Hydrocephalus Association (Other)

Enrollment

Locations

Actual Duration (Months)

9.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Actual Enrollment :

78 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 1, 2011

Actual Primary Completion Date :

Jul 1, 2016

Actual Study Completion Date :

Aug 1, 2016

Outcome Measures

Primary Outcome Measures

Association between ventricle size and neuropsychological outcome [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.

Secondary Outcome Measures

Quality of life [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital of Alabama, University of Alabama	Birmingham	Alabama	United States	35233
2	St. Louis Children's Hospital	Saint 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
5	Texas Children's Hospital	Houston	Texas	United States	77030
6	Primary Children's Hospital	Salt Lake City	Utah	United States	84118
7	Seattle Children's Hospital	Seattle	Washington	United States	98105
8	Sick Children's Hospital	Toronto	Ontario	Canada