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| ID | Type | Description | Link |
|---|---|---|---|
| 1RC1NS068943-01 | U.S. NIH Grant/Contract | View source | |
| HCRN 006 | Other Identifier | HCRN Protocol Number |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
| Hydrocephalus Association | OTHER |
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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.
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.
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| 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 |
| 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 |
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Inclusion Criteria: Patients will be eligible for enrollment if they:
Exclusion Criteria: Patients will be ineligible for enrollment if ANY of the following is true or anticipated:
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Pediatric, school-aged patients presenting with a first time diagnosis of hydrocephalus.
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| Name | Affiliation | Role |
|---|---|---|
| Jay Riva-Cambrin, MD, MSc | Alberta Children's Hospital | Study Chair |
| Richard Holubkov, Ph.D. | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Alabama, University of Alabama | Birmingham | Alabama | 35233 | United States | ||
| St. Louis Children's Hospital |
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| Label | URL |
|---|---|
| Hydrocephalus Clinical Research Network website | View source |
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| ID | Term |
|---|---|
| D006849 | Hydrocephalus |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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 |
| St Louis |
| Missouri |
| 63110 |
| United States |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | United States |
| Monroe Carell Jr. Children's Hospital at Vanderbilt | Nashville | Tennessee | 37232 | United States |
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
| Primary Children's Hospital | Salt Lake City | Utah | 84118 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| Sick Children's Hospital | Toronto | Ontario | Canada |