Pediatric HydrocephalusNCT01007786
The Ventricular Catheter Placement Study: Assessment of Efficacy and Safety of an Ultrasound Guided Shunt Insertion Technique
An observational study of Pediatric Hydrocephalus, run by University of Utah at 4 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Pediatric Hydrocephalus
- How many people
- 67 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Dec 2008to Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric hydrocephalus patients undergoing first time shunt placement for hydrocephalus.
Who may be able to join
- Patients must have clinical and radiographic evidence of hydrocephalus as determined by a pediatric neurosurgeon and require a ventriculoperitoneal shunt (atrial, pleural, gallbladder and other shunt systems are excluded)
- Patients can have no prior history of shunt insertion for hydrocephalus. A history of an external ventricular drain, subgaleal reservoir-catheter, or subgaleal shunt is permissible
- Patients must be less than 18 years of age at the time of shunt insertion
Who cannot join
- Active CSF or abdominal infection
- Spread of tumor in the subarachnoid space documented on enhanced imaging (CT or MRI) of the head or spine
- CSF leak without hydrocephalus
- Pseudotumor cerebri
- Dandy-Walker malformation or arachnoid cyst as a cause of hydrocephalus
- Loculations within the ventricular system
Show all 9Show fewer
- Hydranencephaly, alobar holoprosencephaly or any other congenital anomaly of the brain that severely distorts the ventricular anatomy such that ventricular catheter location cannot be determined
- Other systemic disorders that would preclude the insertion/revision of a ventricular shunt
- Other difficulties that would preclude follow-up at one year (e.g. terminal illness with life expectancy less than 1 year)
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Children's Hospital of Alabama
Birmingham, Alabama, 35233
Texas Children's Hospital
Houston, Texas, 77030
Primary Children's Medical Center
Salt Lake City, Utah, 84113
About this study
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.
- Conditions
- Pediatric Hydrocephalus
- Keywords
- Pediatric Hydrocephalus, Ultrasound Guided Surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint for the study is ventricular catheter location (VCL) as assessed on the first post-operative scan (US, CT, or MRI brain).
Measured: The first post-operative scan will only be used in the study if it occurs within 105 days of shunt insertion.
Secondary outcomes (2)
Shunt survival will be reported.
Measured: Up to one year after the date of shunt placement.
Any complications, intraoperative and postoperative, will be reported.
Measured: From the time of surgery until the time the subject is discharged from the hospital.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2009 (estimated)
- Study startDec 2008
- Primary completionFeb 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric HydrocephalusStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Whitehead, MD, MPH, Study chair, HCRN, Texas Children's HospitalJay Riva-Cambrin, MD, Principal investigator, HCRN, Primary Children's Medical CenterAbhaya Kulkarni, MD, PhD, Principal investigator, HCRN, Sick Children's Hospital, Toronto, OntarioJay Wellons, MD, Principal investigator, HCRN, Children's Hosptial of AlabamaJohn Kestle, MD, Principal investigator, Chair, Hydrocephalus Clinical Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01007786
- Sponsor's protocol ID
- 32371
- Other IDs
- HCRN 002, 1RC1NS068943-01
- Status last verified
- Jun 2012
- First submitted
- 2 Nov 2009
- Last updated
- 14 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24116981
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ventricular Catheter Placement Study: Assessment of Efficacy and Safety of an Ultrasound Guided Shunt Insertion Technique
- ClinicalTrials.gov ID
- NCT01007786
- Acronym / sponsor ID
- 32371
- Conditions
- Pediatric Hydrocephalus
- Keywords
- Pediatric Hydrocephalus, Ultrasound Guided Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Dec 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 4 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric hydrocephalus patients undergoing first time shunt placement for hydrocephalus.
Key inclusion criteria (3 listed)
- Patients must have clinical and radiographic evidence of hydrocephalus as determined by a pediatric neurosurgeon and require a ventriculoperitoneal shunt (atrial, pleural, gallbladder and other shunt systems are excluded)
- Patients can have no prior history of shunt insertion for hydrocephalus. A history of an external ventricular drain, subgaleal reservoir-catheter, or subgaleal shunt is permissible
- Patients must be less than 18 years of age at the time of shunt insertion
Key exclusion criteria (9 listed)
- Active CSF or abdominal infection
- Spread of tumor in the subarachnoid space documented on enhanced imaging (CT or MRI) of the head or spine
- CSF leak without hydrocephalus
- Pseudotumor cerebri
- Dandy-Walker malformation or arachnoid cyst as a cause of hydrocephalus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary endpoint for the study is ventricular catheter location (VCL) as assessed on the first post-operative scan (US, CT, or MRI brain).
Time frame: The first post-operative scan will only be used in the study if it occurs within 105 days of shunt insertion.
2 secondary outcomes
Shunt survival will be reported.
Time frame: Up to one year after the date of shunt placement.
Any complications, intraoperative and postoperative, will be reported.
Time frame: From the time of surgery until the time the subject is discharged from the hospital.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2012.
- Derived from this study: PubMed 24116981Whitehead 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.
- Hydrocephalus Clinical Research NetworkLink provided by the sponsor.
Related trials for Pediatric Hydrocephalus
Not yet recruiting
Ultrasound and Photoacoustic Imaging of Hydrocephalus in Pediatric Patients
Hydrocephalus in Infants, Hydrocephalus in Children
Not yet recruitingObservational study
Bedside Cranial Ultrasound for Risk-Stratified Imaging in Pediatric Acute Brain Injury
Acute Brain Injury, Traumatic Brain Injury
Not yet recruiting
Role of Endoscopic Third Ventriculostomy Imanagement of Hydrocephalus in Pediatric Age Group; Clinical and Surgical Outcome
Hydrocephalus
RecruitingObservational study
HCRN Core Data Project: Characterizing Patient Populations in the Hydrocephalus Clinical Research Network (HCRN)
Pediatric Hydrocephalus
Not yet recruitingPhase 4
Efficacy and Cost-Effectiveness of Topical Vancomycin Powder in Preventing Pediatric Ventriculoperitoneal Shunt Infections Across Different Etiologies
Hydrocephalus, Ventriculoperitoneal Shunt Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Whitehead, MD, MPH study chair
HCRN, Texas Children's Hospital
Jay Riva-Cambrin, MD principal investigator
HCRN, Primary Children's Medical Center
Abhaya Kulkarni, MD, PhD principal investigator
HCRN, Sick Children's Hospital, Toronto, Ontario
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Hydrocephalus, run by University of Utah at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint for the study is ventricular catheter location (VCL) as assessed on the first post-operative scan (US, CT, or MRI brain). (time frame: The first post-operative scan will only be used in the study if it occurs within 105 days of shunt insertion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01007786, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2012.