Ventricular Size Involvement in Neuropsychological Outcomes in Pediatric Hydrocephalus (VINOH)
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Purpose
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 |
|---|
|
Hydrocephalus |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Ventricular Size Involvement in Neuropsychological Outcomes in Pediatric Hydrocephalus (VINOH) |
- Association between ventricle size and neuropsychological outcome [ Time Frame: 6 months after initial surgical treatment for hydrocephalus ] [ Designated as safety issue: No ]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.
- Quality of life [ Time Frame: 6 months after initial surgical treatment for hydrocephalus ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Shunt and ETV revisions or infections will be examined for any correlations with cognitive neuropsychological testing at 6 months from the initial surgical intervention.
| Estimated Enrollment: | 62 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | November 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 5 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Contacts and Locations| Contact: Marcie Langley | 801-662-5364 | marcie.langley@hsc.utah.edu |
| United States, Alabama | |
| Children's Hospital of Alabama | Recruiting |
| Birmingham, Alabama, United States, 35233 | |
| Contact: Amita Bey, MPH 205-939-3474 amita.bey@childrensal.org | |
| Sub-Investigator: Curtis Rozzelle, MD | |
| United States, Missouri | |
| St. Louis Children's Hospital | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Contact: Deanna Mercer 314-454-5498 mercerd@wudosis.wustl.edu | |
| Sub-Investigator: David Limbrick, MD, PhD | |
| United States, Pennsylvania | |
| Children's Hospital of Pittsburgh of UPMC | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15224 | |
| Contact: Arlene M Luther, BS, RN 412-692-9965 luthera@upmc.edu | |
| Sub-Investigator: Mandeep S Tamber, MD, PhD | |
| United States, Texas | |
| Texas Children's Hospital | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Sheila Ryan, MPH, JD 832-822-4074 slryan@texaschildrens.org | |
| Sub-Investigator: William Whitehead, MD | |
| United States, Utah | |
| Primary Children's Medical Center | Recruiting |
| Salt Lake City, Utah, United States, 84113 | |
| Contact: Tracey Bach, BS 801-662-5344 tracey.bach@hsc.utah.edu | |
| Principal Investigator: Jay Riva-Cambrin, MD | |
| United States, Washington | |
| Seattle Children's Hospital | Recruiting |
| Seattle, Washington, United States, 98105 | |
| Contact: Amy Anderson, BS RN 206-987-5916 amy.anderson2@seattlechildrens.org | |
| Sub-Investigator: Samuel R Browd, MD, PhD | |
| Sub-Investigator: Tamara D Simon, MD, MSPH | |
| Canada, Ontario | |
| Sick Children's Hospital | Recruiting |
| Toronto, Ontario, Canada, M5G1X8 | |
| Contact: Brittany Aziz 416-813-7600 ext 28771 brittany.aziz@sickkids.ca | |
| Contact: Maria Lamberti-Pasculli 416-813-6456 maria.lamberti-pasculli@sickkids.ca | |
| Sub-Investigator: Abhaya Kulkarni, MD, PhD | |
| Study Chair: | Jay Riva-Cambrin, MD, MSc | Primary Children's Medical Center |
| Principal Investigator: | Kulkarni Abhaya, MD, PhD | Sick Children's Hospital |
| Principal Investigator: | Curtis Rozzelle, MD | Children's Hospital of Alabama |
| Principal Investigator: | William E Whitehead, MD, MPH | Texas Children's Hospital |
| Principal Investigator: | Samuel R Browd, PhD | Seattle Children's Hospital |
| Principal Investigator: | Tamara D Simon, MD, MSPH | Seattle Children's Hospital |
| Principal Investigator: | David Limbrick, MD, PhD | St. Louis Children's Hospital |
| Principal Investigator: | Mandeep S Tamber, MD, PhD | Children's Hospital of Pittsburgh of UPMC |
| Principal Investigator: | John Kestle, MD | Chair, Hydrocephalus Clinical Research Network |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of Utah |
| ClinicalTrials.gov Identifier: | NCT01797627 History of Changes |
| Other Study ID Numbers: | 49237, 1RC1NS068943-01, HCRN 006 |
| Study First Received: | June 8, 2012 |
| Last Updated: | February 20, 2013 |
| Health Authority: | United States: Institutional Review Board Canada: Research Ethics Board |
Keywords provided by University of Utah:
|
Pediatric Hydrocephalus Ventricular Size Neuropsychological Outcomes Quality of Life |
Additional relevant MeSH terms:
|
Hydrocephalus Brain Diseases Central Nervous System Diseases Nervous System Diseases Intracranial Hypertension |
ClinicalTrials.gov processed this record on May 16, 2013