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| ID | Type | Description | Link |
|---|---|---|---|
| HCRN 002 | Other Identifier | HCRN Protocol Number | |
| 1RC1NS068943-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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Shunt failure remains a significant problem in pediatric patients with hydrocephalus. If reliable techniques for the accurate placement of ventricular catheters can be developed, shunt survival may improve. The purpose of this study is to assess the efficacy and safety of the ultrasound guided shunt insertion technique in the hands of experienced surgeons. The primary outcome measure is ventricular catheter location determined from post-operative brain images. The study is being conducted by the Hydrocephalus Clinical Research Network (HCRN), a network established to conduct multi-institutional clinical trials on pediatric hydrocephalus. Pediatric neurosurgeons at HCRN centers enrolled in this study will perform either ultrasound guided shunt surgery or a conventional shunt surgery. Patients who undergo conventional shunt surgery will serve as a contemporary control group.
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| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint for the study is ventricular catheter location (VCL) as assessed on the first post-operative scan (US, CT, or MRI brain). | The first post-operative scan will only be used in the study if it occurs within 105 days of shunt insertion. |
| Measure | Description | Time Frame |
|---|---|---|
| Shunt survival will be reported. | Up to one year after the date of shunt placement. | |
| Any complications, intraoperative and postoperative, will be reported. | From the time of surgery until the time the subject is discharged from the hospital. |
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Inclusion Criteria:
Exclusion Criteria:
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Pediatric hydrocephalus patients undergoing first time shunt placement for hydrocephalus.
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| Name | Affiliation | Role |
|---|---|---|
| William Whitehead, MD, MPH | HCRN, Texas Children's Hospital | Study Chair |
| Jay Riva-Cambrin, MD | HCRN, Primary Children's Medical Center | Principal Investigator |
| Abhaya Kulkarni, MD, PhD | HCRN, Sick Children's Hospital, Toronto, Ontario | Principal Investigator |
| Jay Wellons, MD | HCRN, Children's Hosptial of Alabama | Principal Investigator |
| John Kestle, MD | Chair, Hydrocephalus Clinical Research Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Alabama | Birmingham | Alabama | 35233 | United States | ||
| Texas Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24116981 | Derived | Whitehead WE, Riva-Cambrin J, Wellons JC 3rd, Kulkarni AV, Holubkov R, Illner A, Oakes WJ, Luerssen TG, Walker ML, Drake JM, Kestle JR; Hydrocephalus Clinical Research Network. No significant improvement in the rate of accurate ventricular catheter location using ultrasound-guided CSF shunt insertion: a prospective, controlled study by the Hydrocephalus Clinical Research Network. J Neurosurg Pediatr. 2013 Dec;12(6):565-74. doi: 10.3171/2013.9.PEDS1346. Epub 2013 Oct 11. |
| Label | URL |
|---|---|
| Hydrocephalus Clinical Research Network | View source |
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| Houston |
| Texas |
| 77030 |
| United States |
| Primary Children's Medical Center | Salt Lake City | Utah | 84113 | United States |
| Sick Children's Hospital | Toronto | Ontario | M5G 1X8 | Canada |