Clinical trial NCT01797627: Ventricular Size Involvement in Neuropsychological Outcomes in Pediatric Hydrocephalus
Official title: Ventricular Size Involvement in Neuropsychological Outcomes in Pediatric Hydrocephalus (VINOH)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hydrocephalus
Keywords: Pediatric Hydrocephalus
Ventricular Size
Neuropsychological Outcomes
Quality of Life
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: Hydrocephalus Association
First posted: 2013-02-22
Enrollment: 78
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric, school-aged patients presenting with a first time diagnosis of hydrocephalus.

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 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 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.

Primary outcomes:
measure: Association between ventricle size and neuropsychological outcome
timeFrame: 6 months after initial surgical treatment for hydrocephalus
Secondary outcomes:
measure: Quality of life
timeFrame: 6 months after initial surgical treatment for hydrocephalus
measure: Academic Performance
timeFrame: 6 months after initial surgical treatment for hydrocephalus
measure: Presence of additional required hydrocephalus related surgeries
timeFrame: 6 months after initial surgical treatment for hydrocephalus
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Children's Hospital of Alabama, University of Alabama
state: Alabama
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh of UPMC
state: Pennsylvania
city: Nashville
country: United States
facility: Monroe Carell Jr. Children's Hospital at Vanderbilt
state: Tennessee
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Salt Lake City
country: United States
facility: Primary Children's Hospital
state: Utah
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Toronto
country: Canada
facility: Sick Children's Hospital
state: Ontario
Study officials:
affiliation: Alberta Children's Hospital
name: Jay Riva-Cambrin, MD, MSc
role: STUDY_CHAIR
affiliation: University of Utah
name: Richard Holubkov, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: