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Shunt Outcomes of Post-Hemorrhagic Hydrocephalus (SOPHH)

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ClinicalTrials.gov Identifier: NCT01480349
Recruitment Status : Completed
First Posted : November 28, 2011
Last Update Posted : December 26, 2017
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
University of Utah

Brief Summary:
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.

Condition or disease
Post-Hemorrhagic Hydrocephalus

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
Actual Enrollment : 146 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Shunt Outcomes of Post-Hemorrhagic Hydrocephalus: A Network Pilot Study
Actual Study Start Date : January 10, 2011
Actual Primary Completion Date : May 10, 2016
Actual Study Completion Date : May 10, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hydrocephalus




Primary Outcome Measures :
  1. 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.

  2. Specific Aim 2: Conversion proportion [ Time Frame: 5 years ]
    The proportion of all infants with SGS or RES who met criteria for conversion to permanent shunt.

  3. Specific Aim 3: Surgery Checklist Scores [ Time Frame: 5 years ]
    Surgery checklist scores of individual surgeon performance in standardized procedures.


Secondary Outcome Measures :
  1. Protocol adherence [ Time Frame: 5 years ]
    Protocol adherence by network, center, surgeon, decision rubric, and individual decision data points.

  2. CSF Infection [ Time Frame: 5 years ]
    Incidence of CSF infection while on the protocol.

  3. Neurodevelopmental Outcomes [ Time Frame: 7 years ]
    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.



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Ages Eligible for Study:   up to 180 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01480349


Locations
United States, Alabama
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
United States, Missouri
St. Louis Children's Hospital
Saint Louis, Missouri, United States, 63110
United States, Pennsylvania
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
United States, Utah
Primary Children's Hospital
Salt Lake City, Utah, United States, 84113
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Canada, Ontario
Sick Children's Hospital
Toronto, Ontario, Canada, M5G1X8
Sponsors and Collaborators
University of Utah
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Study Chair: John C Wellons, III, MD Vanderbilt University Medical Center
Principal Investigator: Chevis N Shannon, MBA, DrPH Vanderbilt University Medical Center

Additional Information:
Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT01480349     History of Changes
Other Study ID Numbers: 46249
1RC1NS068943-01 ( U.S. NIH Grant/Contract )
HCRN 005 ( Other Identifier: HCRN Protocol Number )
First Posted: November 28, 2011    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: December 2017

Keywords provided by University of Utah:
Post-Hemorrhagic Hydrocephalus
Intraventricular Hemorrhage
Low Birth Weight Premature Infants

Additional relevant MeSH terms:
Hydrocephalus
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases