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

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

    • Ontario
      • Toronto, Ontario, Canada, M5G1X8
        • Sick Children's Hospital
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Children's Hospital of Alabama
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • St. Louis Children's Hospital
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Children's Hospital of Pittsburgh of UPMC
    • Texas
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84113
        • Primary Children's Hospital
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Children's Hospital

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.
5 years
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.
5 years
Specific Aim 3: Surgery Checklist Scores
Time Frame: 5 years
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
CSF Infection
Time Frame: 5 years
Incidence of CSF infection while on the protocol.
5 years
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.
7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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.

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

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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