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Shunt Outcomes of Post-Hemorrhagic Hydrocephalus

NCT ID: NCT01480349

Last Updated: 2017-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

146 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-10

Study Completion Date

2016-05-10

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Post-Hemorrhagic Hydrocephalus

Keywords

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Post-Hemorrhagic Hydrocephalus Intraventricular Hemorrhage Low Birth Weight Premature Infants

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Maximum Eligible Age

180 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John C Wellons, III, MD

Role: STUDY_CHAIR

Vanderbilt University Medical Center

Chevis N Shannon, MBA, DrPH

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

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Children's Hospital of Alabama

Birmingham, Alabama, United States

Site Status

St. Louis Children's Hospital

St Louis, Missouri, United States

Site Status

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, United States

Site Status

Texas Children's Hospital

Houston, Texas, United States

Site Status

Primary Children's Hospital

Salt Lake City, Utah, United States

Site Status

Seattle Children's Hospital

Seattle, Washington, United States

Site Status

Sick Children's Hospital

Toronto, Ontario, Canada

Site Status

Countries

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United States Canada

Related Links

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http://hcrn.org

Hydrocephalus Clinical Research Network website

Other Identifiers

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1RC1NS068943-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HCRN 005

Identifier Type: OTHER

Identifier Source: secondary_id

46249

Identifier Type: -

Identifier Source: org_study_id