- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01480349
Shunt Outcomes of Post-Hemorrhagic Hydrocephalus (SOPHH)
December 21, 2017 updated by: University of Utah
Shunt Outcomes of Post-Hemorrhagic Hydrocephalus: A Network Pilot Study
This multicenter, prospective pilot study will compare the effectiveness of two established procedures used in the treatment of post-hemorrhagic hydrocephalus in very low birth weight infants, specifically ventricular reservoirs and subgaleal shunts.
The study is being conducted by the Hydrocephalus Clinical Research Network (HCRN), a network established to conduct multi-institutional clinical trials on pediatric hydrocephalus.
Study Overview
Status
Completed
Conditions
Detailed Description
Intraventricular hemorrhage and post-hemorrhagic hydrocephalus remain a leading cause of mortality and long-term morbidity in premature infants.
The two most common temporary cerebrospinal fluid (CSF) diversion procedures are the ventriculosubgaleal shunt (SGS) and an implanted ventricular reservoir (RES) for intermittent CSF removal.
These methods are physiologically very different and their comparative effectiveness in treating hydrocephalus and possibly reducing the need for an eventual permanent CSF shunt is currently not known.
The goal of this pilot study is to obtain information critical for planning and executing a future randomized trial comparing SGS and RES.
Specifically, this pilot study will establish inclusion criteria, define the primary outcome, and standardize the interventions in preparation for initiating a comparative trial between the SGS and RES procedures.
In addition, the importance of examining the neurodevelopmental outcomes for these patients has been recognized within the neurosurgical and neuropsychological settings.
Therefore, the scope of this study has been extended to include an examination of the neurodevelopmental outcomes at 18 to 22 months and at 36 to 42 months in patients who undergo BSID-III testing at their clinical centers.
Study Type
Observational
Enrollment (Actual)
146
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G1X8
- Sick Children's Hospital
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Alabama
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Birmingham, Alabama, United States, 35233
- Children's Hospital of Alabama
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Missouri
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Saint Louis, Missouri, United States, 63110
- St. Louis Children's Hospital
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15224
- Children's Hospital of Pittsburgh of UPMC
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Texas
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Houston, Texas, United States, 77030
- Texas Children's Hospital
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Utah
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Salt Lake City, Utah, United States, 84113
- Primary Children's Hospital
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Washington
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Seattle, Washington, United States, 98105
- Seattle Children's Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 5 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All premature neonates with grade III or IV intraventricular hemorrhage who primarily present or are referred prior to surgical intervention for post hemorrhagic hydrocephalus to HCRN Clinical Centers.
Description
Inclusion Criteria:
- premature neonates with birth weights less than 1500 grams
- Grade III or IV intraventricular hemorrhage
- Fronto-occipital horn ratio greater than or equal to 0.50
Exclusion Criteria:
- Less than 72 hour life expectancy from other medical problems
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Specific Aim I: Proportion of temporization
Time Frame: 5 years
|
The proportion of all infants entering the study who meet the criteria for surgical temporization.
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5 years
|
Specific Aim 2: Conversion proportion
Time Frame: 5 years
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The proportion of all infants with SGS or RES who met criteria for conversion to permanent shunt.
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5 years
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Specific Aim 3: Surgery Checklist Scores
Time Frame: 5 years
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Surgery checklist scores of individual surgeon performance in standardized procedures.
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Protocol adherence
Time Frame: 5 years
|
Protocol adherence by network, center, surgeon, decision rubric, and individual decision data points.
|
5 years
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CSF Infection
Time Frame: 5 years
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Incidence of CSF infection while on the protocol.
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5 years
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Neurodevelopmental Outcomes
Time Frame: 7 years
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Subscores from the Bayley Scales of Infant Development, version III (BSID-III) to include cognitive, language and motor subtests will be obtained for patients undergoing BSID-III testing at 18-22 and 36-42 months of age.
|
7 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: John C Wellons, III, MD, Vanderbilt University Medical Center
- Principal Investigator: Chevis N Shannon, MBA, DrPH, Vanderbilt University Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 10, 2011
Primary Completion (Actual)
May 10, 2016
Study Completion (Actual)
May 10, 2016
Study Registration Dates
First Submitted
November 23, 2011
First Submitted That Met QC Criteria
November 23, 2011
First Posted (Estimate)
November 28, 2011
Study Record Updates
Last Update Posted (Actual)
December 26, 2017
Last Update Submitted That Met QC Criteria
December 21, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 46249
- 1RC1NS068943-01 (U.S. NIH Grant/Contract)
- HCRN 005 (Other Identifier: HCRN Protocol Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Post-Hemorrhagic Hydrocephalus
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Umeå UniversityCompleted
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