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U.S. Department of Health and Human Services

Medical Devices

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Pediatric Assessments of Neurological and Neurocognitive Function for Cardiovascular Devices Workshop, March 25, 2010

Overview

Workshop Objective and Format:

The purpose of this workshop is to explore strategies for the standardization of pediatric neurological function and neurocognitive assessments in pediatric mechanical circulatory support devices.

The meeting will begin with introductory presentations to provide background on the current state of neurological and neurocognitive assessments and the need for more information to safely and effectively assess patients implanted with medical devices. Attendees will then split into workgroups focused on: 1) neurological, or 2) neurocognitive function. Each workgroup will be tasked with developing a summary of recommendations in designing and conducting pediatric assessments for brain function. There will be summary presentations by each workgroup with Q&A.

This workshop was organized to discuss the following objectives:

  • To review the importance of assessing neurological functional in children undergoing pediatric mechanical circulatory support
  • To review currently available strategies/tools to assess pediatric neurological and neurocognitive function
  • To review the limitations of performing neurological testing in a critically ill population of children with severe cardiac dysfunction over a wide age range
  • To develop a standardized approach to neurological testing that is both feasible and meaningful for drawing inferences about device safety for the clinical and regulatory communities.

To develop a (2-year) plan to address remaining challenges (validation of instruments, future workshops, guidance, and/or publications)

Date, Time and Location

The meeting will be held on March 25 (7:30 a.m. to 5:00 p.m.) at the following location:

Food and Drug Administration
Building 2, Room 2047
10903 New Hampshire Ave.
Silver Spring, MD 20993

Agenda

7:30AM Arrive at White Oak (security screening)
Registration
8:15 AM Welcome and Introduction from Co-Chairs/Logistics
  • Sonna Patel-Raman, Ph.D.
    Biomedical Engineer, Scientific Reviewer
    Division of Cardiovascular Devices
    Center for Devices and Radiological Health (CDRH)
    US Food and Drug Administration (FDA)
  • Chris Almond, M.D.
    Pediatric Cardiologist
    Children’s Hospital Boston
8:20 AM Importance of Pediatric Assessments from a Regulatory Perspective
  • Sonna Patel-Raman, Ph.D.
8:30 AM Current State of the Field – What we know and what we don’t; why are we here
  • David Bellinger, Ph.D.

Session 1 : Introduction to Patient Population

8:45 AM Introduction to the Patient Population - Baseline and On-Device Assessments; Importance of family understanding real risks and benefits
  • David Rosenthal, M.D.
    Pediatric Cardiologist
    Lucile Packard Children’s Hospital
    Palo Alto, CA
8:55 AM Surgical Perspective – A Case Study
  • Peter Wearden, M.D., Ph.D.
    Associate Professor of Cardiothoracic Surgery, Congenital Cardiothoracic Surgeon
    Children’s Hospital of Pittsburgh

Session 2: Current Practices in Pediatric Neurological, Neurocognitive and Quality of Life Assessments

9:05 AM Imaging Assessments
  • Tae Chang, M.D.
    Pediatric Neurologist
    Children’s National Medical Center
9:25 AM Neurological Assessments - Review of the library of tests to choose from)
  • Rebecca Ichord, M.D.
    Pediatric Neurologist
    Children’s Hospital of Philadelphia
9:45 AM Neurocognitive/Neurodevelopmental Assessments -
  • David Bellinger, Ph.D.
    Professor of Neurology
    Children’s Hospital Boston
10:05AM Quality of Life
  • Karen Uzark
  • Cincinnati Children’s Hospital
10:25 AM Break

Session 3: Challenges and Limitations

10:45AM Landscape of Adult Neurological Assessments – Development of the field - Challenges and Limitations –What is the vision for pediatric patients?
  • Ralph Petrucci, Ed.D.
    Clinical Professor, Neuropsychology
    Drexel University College of Medicine
11:00AM Availability of Assessments - Economics, Risk, and Benefit
  • Janice Ware, Ph.D.
    Assistant Professor, Developmental Medicine
    Children’s Hospital Boston
11:15 AM Industry Framework - What is reasonable, what are the challenges and limitations?
  • John Marks
    Director of Clinical Research
    Levitronix, LLC
11:30AM Given Challenges, Now What? - Putting it All Together
  • Chris Almond, M.D.
    Pediatric Cardiologist
    Children’s Hospital Boston
11:45 AM Lunch
12:45 PM Meet in Main Room for directions regarding breakout sessions Breakout Sessions (Room 2047 East and West, front, back) Objective: Recommendations for testing and frequency (ideally want clinical and industry representation in each group)
  • Group #1 (East, front) – Imaging (Leader: Tae Chang)
  • Group #2 (East, back) – Neurological Exam (Leader: Rebecca Ichord)
  • Group #3 (West, front) – Neurofunction/Neurocognitive (Leader: David Bellinger)
  • Group #4 (West, back) – QOL (TBD)
2:15 PM Break
2:30 PM Summary – Group Leaders 1, 2, 3, 4 (20 minutes each)
3:30 PM Recommendations – Fill in the chart
4:00 PM Action Items/Future Work
4:30 PM Questions/Wrap-Up
5:00 PM Adjourn

Registration

To register, use our online registration system. Please only submit one registration. Note that no confirmation letter will be sent.

There is no registration fee to attend the meeting, but attendees must register in advance. Please submit registration early in order to reserve a space, as space is limited. You may register on-line until March 19, 2010. If you require special accommodations due to a disability, please contact Shreya Mehta, (301) 796-0750 at least 7 days prior to the meeting.

Contact Us

The workshop organizer may be contacted at:

Shreya Mehta
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue WO-66-1543
Silver Spring, MD 20993
Phone: 301-796-0750
email: shreya.mehta@fda.hhs.gov