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Shunt Outcomes of Post-Hemorrhagic Hydrocephalus (SOPHH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University of Utah
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT01480349
First received: November 23, 2011
Last updated: February 21, 2013
Last verified: February 2013

November 23, 2011
February 21, 2013
January 2011
January 2018   (final data collection date for primary outcome measure)
  • Specific Aim I: Proportion of temporization [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    The proportion of all infants entering the study who meet the criteria for surgical temporization.
  • Specific Aim 2: Conversion proportion [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Surgery checklist scores of individual surgeon performance in standardized procedures.
  • Specific Aim I: Proportion of temporization [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    The proportion of all infants entering the study who meet the criteria for surgical temporization.
  • Specific Aim 2: Conversion proportion [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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: 18 months ] [ Designated as safety issue: No ]
    Surgery checklist scores of individual surgeon performance in standardized procedures.
Complete list of historical versions of study NCT01480349 on ClinicalTrials.gov Archive Site
  • Protocol adherence [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Protocol adherence by network, center, surgeon, decision rubric, and individual decision data points.
  • CSF Infection [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Incidence of CSF infection while on the protocol.
  • Neurodevelopmental Outcomes [ Time Frame: 7 years ] [ Designated as safety issue: No ]
    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 months of age.
  • Protocol adherence [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Protocol adherence by network, center, surgeon, decision rubric, and individual decision data points.
  • Bayley Scales [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Bayley Scales of Infant Development III scores (6 months of age, corrected)
  • CSF Infection [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Incidence of CSF infection while on the protocol.
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Shunt Outcomes of Post-Hemorrhagic Hydrocephalus
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.

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 in patients who undergo BSID-III testing at their clinical centers.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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.

Post-Hemorrhagic Hydrocephalus
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
325
August 2020
January 2018   (final data collection date for primary outcome measure)

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
Both
up to 180 Days
No
Contact: Marcie Langley 801-662-5364 marcie.langley@hsc.utah.edu
United States,   Canada
 
NCT01480349
46249, 1RC1NS068943-01, HCRN 005
No
University of Utah
University of Utah
National Institute of Neurological Disorders and Stroke (NINDS)
Study Chair: John C Wellons, III, MD Vanderbilt University
Principal Investigator: Jay Riva-Cambrin, MD, MSc Primary Children's Hospital
Principal Investigator: William E Whitehead, MD, MPH Texas Children's Hospital
Principal Investigator: Abhaya Kulkarni, MD, PhD Sick Children's Hospital
Principal Investigator: Samuel R Browd, MD, PhD Seattle Children's Hospital
Principal Investigator: Tamara D Simon, MD, MSPH Seattle Children's Hospital
Principal Investigator: David Limbrick, MD, PhD St. Louis Children's Hospital
Principal Investigator: Mandeep S Tamber, MD, PhD Children's Hospital of Pittsburgh of UPMC
Principal Investigator: John Kestle, MD Chair, Hydrocephalus Clinical Research Network
Principal Investigator: Chevis N Shannon, MBA, DrPH Vanderbilt University
Principal Investigator: Curtis Rozzelle, MD Children's Hospital of Alabama
University of Utah
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP