HydrocephalusVINOHNCT01797627
Ventricular Size Involvement in Neuropsychological Outcomes in Pediatric Hydrocephalus
An observational study of Hydrocephalus, run by University of Utah at 8 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Hydrocephalus
- How many people
- 78 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Aug 2011to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric, school-aged patients presenting with a first time diagnosis of hydrocephalus.
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.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States7 sites
Children's Hospital of Alabama, University of Alabama
Birmingham, Alabama, 35233
Texas Children's Hospital
Houston, Texas, 77030
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
Primary Children's Hospital
Salt Lake City, Utah, 84118
Seattle Children's Hospital
Seattle, Washington, 98105
St. Louis Children's Hospital
St Louis, Missouri, 63110
About this study
Official title: 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.
Read the 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.
- Conditions
- Hydrocephalus
- Keywords
- Pediatric Hydrocephalus, Ventricular Size, Neuropsychological Outcomes, Quality of Life
- Medical subject headings
- Hydrocephalus
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after initial surgical treatment for hydrocephalus
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 6 months after initial surgical treatment for hydrocephalus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2013 (estimated)
- Study startAug 2011
- Primary completionJul 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydrocephalusStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Hydrocephalus Association
- Responsible party
- Principal investigator, richard holubkov, University of Utah
- Investigators
- Jay Riva-Cambrin, MD, MSc, Study chair, Alberta Children's HospitalRichard Holubkov, Ph.D., Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01797627
- Sponsor's protocol ID
- 49237
- Other IDs
- 1RC1NS068943-01, HCRN 006
- Acronym
- VINOH
- Status last verified
- Jan 2020
- First submitted
- 8 Jun 2012
- Last updated
- 29 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventricular Size Involvement in Neuropsychological Outcomes in Pediatric Hydrocephalus (VINOH)
- ClinicalTrials.gov ID
- NCT01797627
- Acronym / sponsor ID
- VINOH / 49237
- Conditions
- Hydrocephalus
- Keywords
- Pediatric Hydrocephalus, Ventricular Size, Neuropsychological Outcomes, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Hydrocephalus Association
- Study start
- Aug 2011 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 22 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric, school-aged patients presenting with a first time diagnosis of hydrocephalus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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.
3 secondary outcomes
Quality of life
Time frame: 6 months after initial surgical treatment for hydrocephalus
Academic Performance
Time frame: 6 months after initial surgical treatment for hydrocephalus
Presence of additional required hydrocephalus related surgeries
Time frame: 6 months after initial surgical treatment for hydrocephalus
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
- Hydrocephalus Clinical Research Network websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Hydrocephalus
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jay Riva-Cambrin, MD, MSc study chair
Alberta Children's Hospital
Richard Holubkov, Ph.D. principal investigator
University of Utah
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hydrocephalus, run by University of Utah at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between ventricle size and neuropsychological outcome (time frame: 6 months after initial surgical treatment for hydrocephalus). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2020; AzTrials last refreshed its copy on 7 Nov 2026.