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Shunt Outcomes of Post-Hemorrhagic Hydrocephalus (SOPHH)

This study is ongoing, but not recruiting participants.
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
University of Utah Identifier:
First received: November 23, 2011
Last updated: November 14, 2016
Last verified: November 2016
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.

Post-Hemorrhagic Hydrocephalus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Shunt Outcomes of Post-Hemorrhagic Hydrocephalus: A Network Pilot Study

Resource links provided by NLM:

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • 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.

  • 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.

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

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

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

  • 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.

Estimated Enrollment: 146
Study Start Date: January 2011
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
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.

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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01480349

United States, Alabama
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
United States, Missouri
St. Louis Children's Hospital
St. 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)
Study Chair: John C Wellons, III, MD Vanderbilt University Medical Center
Principal Investigator: Chevis N Shannon, MBA, DrPH Vanderbilt University Medical Center
  More Information

Additional Information:
Responsible Party: University of Utah Identifier: NCT01480349     History of Changes
Other Study ID Numbers: 46249
1RC1NS068943-01 ( US NIH Grant/Contract Award Number )
HCRN 005 ( Other Identifier: HCRN Protocol Number )
Study First Received: November 23, 2011
Last Updated: November 14, 2016

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

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases processed this record on April 24, 2017