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
  Purpose

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
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 ] [ 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 325
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 in patients who undergo BSID-III testing at their clinical centers.

  Eligibility

Ages Eligible for Study:   up to 180 Days
Genders Eligible for Study:   Both
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
  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 ClinicalTrials.gov identifier: NCT01480349

Contacts
Contact: Marcie Langley 801-662-5364 marcie.langley@hsc.utah.edu

Locations
United States, Alabama
Children's Hospital of Alabama Recruiting
Birmingham, Alabama, United States, 35233
Contact: Amita Bey, MPH    205-939-9474    Amita.Bey@childrensal.org   
Principal Investigator: Curtis Rozzelle, MD         
United States, Missouri
St. Louis Children's Hospital Recruiting
St. Louis, Missouri, United States, 63110
Contact: Deanna Mercer    314-454-5498    mercerd@wudosis.wustl.edu   
Sub-Investigator: David Limbrick, MD, PhD         
United States, Pennsylvania
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Arlene M Luther, BS, RN    412-692-9965    luthera@upmc.edu   
Sub-Investigator: Mandeep S Tamber, MD, PhD         
United States, Texas
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Sheila Ryan, MPH, JD    832-822-4074    slryan@texaschildrens.org   
Sub-Investigator: William Whitehead, MD         
United States, Utah
Primary Children's Medical Center Recruiting
Salt Lake City, Utah, United States, 84113
Contact: Tracey Bach, BS    801-662-5344    tracey.bach@hsc.utah.edu   
Sub-Investigator: Jay Riva-Cambrin, MD         
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Amy Anderson, BSN, RN    206-987-5916    amy.anderson2@seattlechildrens.org   
Sub-Investigator: Samuel R Browd, MD, PhD         
Sub-Investigator: Tamara D Simon, MD, MSPH         
Canada, Ontario
Sick Children's Hospital Recruiting
Toronto, Ontario, Canada, M5G1X8
Contact: Brittany Aziz    416-813-7600 ext 28771    brittany.aziz@sickkids.ca   
Contact: Maria Lamberti-Pasculli    416-813-6456      
Sub-Investigator: Abhaya Kulkarni, MD, PhD         
Sponsors and Collaborators
University of Utah
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT01480349     History of Changes
Other Study ID Numbers: 46249, 1RC1NS068943-01, HCRN 005
Study First Received: November 23, 2011
Last Updated: February 21, 2013
Health Authority: United States: Institutional Review Board
Canada: Research Ethics Board

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
Intracranial Hypertension

ClinicalTrials.gov processed this record on August 21, 2014