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| Sponsored by: |
University of Utah |
|---|---|
| Information provided by: | University of Utah |
| ClinicalTrials.gov Identifier: | NCT00670735 |
Purpose
The Hydrocephalus Clinical Research Network (HCRN) has been established by philanthropic funding to conduct multi-institutional research (clinical trials and observational studies) on pediatric hydrocephalus. The HCRN consists of four Clinical Centers and the Data Coordinating Center (DCC). The HCRN Core Data Project will obtain data about all neurosurgical hydrocephalus events from the network Clinical Centers, and create a database to be used by HCRN investigators. The ongoing maintenance of the Core Data Project serves two main purposes: (1) ) it will help investigators understand the variability, progression, and current treatment practices for hydrocephalus in children, with an ultimate goal of better guiding and assessing therapeutic intervention and providing recommendations on patient care and; (2 it will provide pilot and descriptive data necessary for hypothesis generation and study design (i.e. preliminary power analyses, recruitment projections) for studies under development by the HCRN This multi-institutional database will be maintained throughout the lifetime of the HCRN, and may be useful for tracking trends in pediatric hydrocephalus over time. The Core Data Project will be an invaluable resource to the HCRN and will help stimulate new research protocols, identify potential need for future expansion of the network to incorporate additional patient populations, and provide a descriptive understanding of children with hydrocephalus cared for within the network.
| Condition |
|---|
|
Pediatric Hydrocephalus |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | HCRN Core Data Project: Characterizing Patient Populations in the Hydrocephalus Clinical Research Network (HCRN) |
| Estimated Enrollment: | 1400 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | December 2020 |
| Estimated Primary Completion Date: | December 2020 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | up to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Pediatric Hydrocephalus patients.
Inclusion Criteria:
Information for all neurosurgical hydrocephalus patient events will be obtained from each HCRN Clinical Center and will be placed continuously into the Core Data Project. The first calendar year will be 2008, and data collection will continue for the duration of the existence of the HCRN. Neurosurgical hydrocephalus patient events include any operation for the treatment of documented hydrocephalus including the following:
Exclusion Criteria:
The following temporary CSF diversion procedures will not be included in the Core Date Project:
Contacts and Locations| Contact: Marcie Langley | 801-662-5364 | marcie.langley@hsc.utah.edu |
| United States, Alabama | |
| Children's Hospital of Alabama, University of Alabama | Recruiting |
| Birmingham, Alabama, United States, 35233 | |
| Contact: Chevis Shannon, MBA, MPH 205-939-5838 Chevis.Shannon@chsys.org | |
| Principal Investigator: Jay Wellons, MD | |
| United States, Texas | |
| Texas Children's Hospital | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Sheila Nguyen, MPH, CCRP 832-822-4074 sxnguyen@texaschildrenshospital.org | |
| Principal Investigator: William Whitehead, MD | |
| United States, Utah | |
| Primary Children's Medical Center | Recruiting |
| Salt Lake City, Utah, United States, 84118 | |
| 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 | Not yet recruiting |
| Seattle, Washington, United States, 98105 | |
| Contact: Samuel R. Browd, M.D., Ph.D. 206-987-2544 samuel.browd@seattlechildrens.org | |
| Principal Investigator: Samuel R. Browd, M.D., Ph.D. | |
| Canada, Ontario | |
| Sick Children's Hospital | Recruiting |
| Toronto, Ontario, Canada | |
| Contact: Lindsay O'Connor, MSc 416-813-6456 lindsay.oconnor@sickkids.ca | |
| Principal Investigator: Abhaya Kulkarni, MD | |
| Study Chair: | Jay Riva-Cambrin, MD | Primary Children's Medical Center |
| Principal Investigator: | William Whitehead, MD | Texas Children's Hospital |
| Principal Investigator: | Jay Wellons, MD | Children's Hospital of Alabama, University of Alabama |
| Principal Investigator: | Abhaya Kulkarni, MD | Sick Children's Hospital, Toronto, Ontario |
| Principal Investigator: | Samuel R. Browd, M.D., Ph.D. | Seattle Children's Hospital |
More Information
| Responsible Party: | Hydrocephalus Clinical Research Network ( John Kestle, MD ) |
| Study ID Numbers: | 27896, HCRN 001 |
| Study First Received: | April 30, 2008 |
| Last Updated: | March 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00670735 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Pediatric Hydrocephalus |
|
Pseudotumor Cerebri Infant, Newborn, Diseases Central Nervous System Diseases Hydrocephalus |
Brain Diseases Intracranial Hypertension Hypertension |
|
Nervous System Diseases Infant, Newborn, Diseases Central Nervous System Diseases |
Hydrocephalus Brain Diseases Intracranial Hypertension |