NCT01007786|Completed
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Sponsor study identifier
Secondary identifiers
OTHER · HCRN Protocol Number
observational
67
2 countries
4
Study Start
December 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2010
Actual (reported)Study Completion
March 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2011
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2008
Date type not reportedThis date has not been verified as actual or estimated.
November 2, 2009
Actual (reported)November 4, 2009
Actual (reported)February 2010
Actual (reported)March 2011
Actual (reported)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.
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.
Pediatric hydrocephalus patients undergoing first time shunt placement for hydrocephalus.
Children's Hospital of Alabama
Birmingham, Alabama, 35233, United States
Texas Children's Hospital
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
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.
William Whitehead, MD, MPH
HCRN, Texas Children's Hospital
Jay Riva-Cambrin, MD
HCRN, Primary Children's Medical Center
Abhaya Kulkarni, MD, PhD
HCRN, Sick Children's Hospital, Toronto, Ontario
Jay Wellons, MD
HCRN, Children's Hosptial of Alabama
67 participants (actual enrollment reported by the registry).
First Submitted
November 2, 2009
First Posted
November 4, 2009
Study Start
December 2008
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
John Kestle, MD
Chair, Hydrocephalus Clinical Research Network
Primary Completion
February 2010
Actual (reported)Study Completion
March 2011
Actual (reported)Last Updated
June 14, 2012
Record last verified: 2012-06
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Source: ClinicalTrials.gov.
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