1. National Pediatric Critical Care Collaborative Research Network
Carol E. Nicholson, MD
NIH/NICHD/NCMRR
Pediatric Critical Care and Rehabilitation Research

2. Vision
a collaborative pediatric critical care research network of interactive clinical and translational science research groups.

3. Purpose and Vision -I
promote the efficient comparison of novel critical care treatment methods and management strategies of potential benefit for children and who are critically ill and/or injured.

4. Purpose and Vision-II
Fund the infrastructure required for a network of six core clinical centers to perform clinical trials, translational and descriptive research in pediatric critical illness and injury

5. Purpose and Vision- III
Seek descriptive and translational science in the pathophysiology of critical illness in children, especially……

6. In survivors of childhood critical illness….
Linking outcomes (functional and developmental) to critical illness and its management
Minimizing the effect on siblings and families of devastating childhood illness
Reintegration of child into home, school, family as the ultimate goal of critical care practice

7. In the subspecialty….
Understanding the pathophysiology of critical illness, particularly multiple organ system failure (MOSF)
Evaluating practice: our own, other specialties caring for children.
Finding adequate outcome measures of pediatric critical care practice

8. How will the Network be Constituted ?
Up to six core clinical centers
Data Coordinating Center
NICHD assistance
Project Officer
Project Scientist
Steering Committee
Chairman

9. The Money……. Total amount of “set-aside”: $5M (years 2-5)
$1M Data Coordinating Center (separate RFA)
To fund core clinical centers: $4M

10. How much each, for what? Infrastructure operating costs:
Each center: direct costs:
First year $100,000
Years 2-5 $450,000
Full time research nurse
10-15% PI time
Half time data entry /administrative staff

11. To qualify, these centers MUST…..
HAVE STRONG FOLLOWUP of CHILDREN who have devastating illness or injury
Your longer term care colleagues are looking for you….get involved!

12. Governance of the Network
Steering Committee
consists of:
PI’s
NICHD Project Scientist
DCC PI
Chairman (NICHD appointed)

13. Choosing a Funding Mechanism

14. What is a Cooperative Agreement?
Substantial NICHD scientific and/or programmatic involvement with the recipient is anticipated.
An award instrument establishing an "assistance relationship” between the NIH institutes (NICHD) and a recipient.

15. To Clarify, a bit…. NICHD’s purpose in this relationship :
to support and/or stimulate the recipient's activity by involvement in and otherwise facilitating the activity in a "partner" role
avoid a dominant role, direction, or prime responsibility.

16. How will applicants be evaluated?
Three areas
Characteristics of the Proposed Center
Principal Investigator and Identified Research Nurse
Proposed Science

17. Review of Applications
CRITERIA include:
Significance
Approach
Investigator
Environment
Additional Review Criteria in RFA…

18. The review will be by a “SEP”
Special Emphasis Panel, convened by NICHD just for this purpose.
The Scientific Review Administrator will select and invite the review committee members
Not all members of the review group will be intensivists

19. Looking at the three aspects of the application to be submitted
A paradigm: preparing to board the train
Is it the right train for you?
Don’t get on the train to New York if you want to get to Kansas City

20. Characteristics of the Center
A table of the characteristics of your pediatric critical care service:
# of patients in each category
Institutional personnel and services

21. Principal Investigator and Research Nurse
Evidence of commitment to research
Evidence of commitment to collaboration
Research Nurse must be identified at the time of application
Each Principal Investigator must be a fully qualified pediatric intensivist.

22. Don’t let the timing bother you….
Publication: April, 2004
Applications due August 9, 2004
Anticipated funding Spring, 2005

23. …..Summer, 2004 Due date August, 2004
start now, so that summer is peaceful, and the Network applications begin to………

24. Develop with passion and precision………

25. … help one another get started

26. Things to do first!
Identify research nurse and princicpal investigator
Get buy-in at your institution….is this the right train for you? Ask the neos…
Identify the science you will propose and begin the SEVEN STEPS…make your notebook
You will need to know ages and diagnostic categories of PICU patients…..

27. California Dreamin’