Pediatric HydrocephalusNCT00670735
HCRN Core Data Project: Characterizing Patient Populations in the Hydrocephalus Clinical Research Network (HCRN)
An observational study of Pediatric Hydrocephalus, run by University of Utah at 14 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Pediatric Hydrocephalus
- How many people
- 1,400 participants
- Where
- 14 sitesin 2 countries
- Study dates
- Apr 2008to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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.
Who may be able to join
- 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:
- Ventriculoperitoneal shunt
- Ventriculoatrial shunt
- Ventriculopleural shunt
- Arachnoid cyst shunts
- Subdural shunts
Show all 13Show fewer
- Lumboperitoneal shunts
- Shunts replaced after treatment of infection
- Shunts exposed during an operations but not revised
- Endoscopic third ventriculostomies
- Ommaya reservoir(s)
- Ventricular access devices/reservoirs
- Subgaleal shunts.
Who cannot join
- The following temporary cerebrospinal fluid (CSF) diversion procedures will not be included in the Core Date Project:
- External ventricular drain(s)
Trial locations and contacts
14 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
14 sites in 2 countries
United States11 sites, 11 recruiting
- Recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045
Susan Staulcup, 303-724-5935, SUSAN.STAULCUP@UCDENVER.EDU
Todd Hankinson, MD
- Not yet recruiting
Johns Hopkins Children's Center
Baltimore, Maryland, 21287
Adam Loudermilk, 410-502-4031, alouder1@jhmi.edu
Edward Ahn, MD
- Recruiting
Children's Hospital of Alabama, University of Alabama
Birmingham, Alabama, 35233
Anastasia Arynchyna, MPH, 205-638-5018, arynch@uab.edu
Curtis J Rozzelle, MD
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Adrienne Boczar, MPH, 614-722-8786, Adrienne.Boczar@nationwidechildrens.org
Jonathan Pindrik, MD
- Recruiting
Texas Children's Hospital
Houston, Texas, 77030
Sheila Martinez, BS, 832-822-0653, srmarti2@texaschildrens.org
William Whitehead, MD
- Recruiting
Children's Hospital of Los Angeles
Los Angeles, California, 90027
Christina Artime, BSN, MSHCM, 323-361-7757, cartime@chla.usc.edu
Mark Krieger, MD
- Recruiting
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
Deonte Dawson, BS, 615-343-3251, deonte.dawson@vanderbilt.edu
John C Wellons, III, MD, MSPH
- Recruiting
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
Kimberly Diamond, BS, BA, 412-692-9965, Kldiamond@pitt.edu
Mandeep S Tamber, MD, PhD
- Recruiting
Primary Children's Hospital
Salt Lake City, Utah, 84118
Jason Clawson, BA, 801-662-5369, jason.clawson@hsc.utah.edu
John Kestle, MD
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Gloria Bowen, MA, 206-987-5916, gloria.bowen@seattlechildrens.org
Amy Anderson, BSN, RN, 206-987-5916, amy.anderson2@seattlechildrens.org
- Recruiting
St. Louis Children's Hospital
St Louis, Missouri, 63110
Mohamed Gabir, 314-454-5498, mgabir@wustl.edu
David Limbrick, MD, PhD
Canada3 sites, 3 recruiting
- Recruiting
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
Salim Ahmed, MSc, 403-955-5738, salahmed@ucalgary.ca
Jay Riva-Cambrin, MD
- Recruiting
Sick Children's Hospital
Toronto, Ontario
Homa Ashrafpour, 416-813-7654 ext. 328771, homa.ashrafpour@sickkids.ca
Abhaya Kulkarni, MD, PhD
- Recruiting
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4
Alexander Cheong, BSc, 604-875-2345 ext. 7132, alexander.cheong@cw.bc.ca
Patrick McDonald, MD
About this study
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. In addition to philanthropic funding, the HCRN has also received an NIH NINDS Challenge Grant to support the network infrastructure which allows for the conduct of this and other network studies. The HCRN consists of multiple 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.
- Conditions
- Pediatric Hydrocephalus
- Keywords
- Pediatric Hydrocephalus
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe the number and characteristics of neurosurgical hydrocephalus patient events to HCRN Clinical Centers such as patient demographics, etiology of hydrocephalus, diagnostic information, as well as surgical and medical management decisions.
Measured: 5+ years
Secondary outcomes (1)
To provide this data to HCRN investigators to support hypothesis generation and study design development for clinical trials and observational studies to be carried out by the HCRN.
Measured: 5+ years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2008 (estimated)
- Study startApr 2008
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, richard holubkov, University of Utah
- Investigators
- Jay Riva-Cambrin, MD, Study chair, Alberta Children's HospitalAbhaya Kulkarni, MD, PhD, Principal investigator, Sick Children's Hospital, Toronto, OntarioTamara D Simon, MD, MSPH, Principal investigator, University of Washington / Seattle Children's HospitalRichard Holubkov, Ph.D., Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00670735
- Sponsor's protocol ID
- 27896
- Other IDs
- HCRN 001, 1RC1NS068943-01
- Status last verified
- May 2026
- First submitted
- 30 Apr 2008
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HCRN Core Data Project: Characterizing Patient Populations in the Hydrocephalus Clinical Research Network (HCRN)
- ClinicalTrials.gov ID
- NCT00670735
- Acronym / sponsor ID
- 27896
- Conditions
- Pediatric Hydrocephalus
- Keywords
- Pediatric Hydrocephalus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Apr 2008
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 2 May 2008 (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.
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. In addition to philanthropic funding, the HCRN has also received an NIH NINDS Challenge Grant to support the network infrastructure which allows for the conduct of this and other network studies. The HCRN consists of multiple 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.
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.
Key inclusion criteria (13 listed)
- 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:
- Ventriculoperitoneal shunt
- Ventriculoatrial shunt
- Ventriculopleural shunt
- Arachnoid cyst shunts
Key exclusion criteria (2 listed)
- The following temporary cerebrospinal fluid (CSF) diversion procedures will not be included in the Core Date Project:
- External ventricular drain(s)
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
To describe the number and characteristics of neurosurgical hydrocephalus patient events to HCRN Clinical Centers such as patient demographics, etiology of hydrocephalus, diagnostic information, as well as surgical and medical management decisions.
Time frame: 5+ years
1 secondary outcome
To provide this data to HCRN investigators to support hypothesis generation and study design development for clinical trials and observational studies to be carried out by the HCRN.
Time frame: 5+ years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Hydrocephalus Clinical Research NetworkLink provided by the sponsor.
Related trials for Pediatric Hydrocephalus
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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.
Jay Riva-Cambrin, MD study chair
Alberta Children's Hospital
Abhaya Kulkarni, MD, PhD principal investigator
Sick Children's Hospital, Toronto, Ontario
Tamara D Simon, MD, MSPH principal investigator
University of Washington / Seattle Children's Hospital
14 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 14 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 13 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marcie Langley (801-662-5364, marcie.langley@hsc.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To describe the number and characteristics of neurosurgical hydrocephalus patient events to HCRN Clinical Centers such as patient demographics, etiology of hydrocephalus, diagnostic information, as well as surgical and medical management decisions. (time frame: 5+ years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2026.