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

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

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.

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

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

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

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

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

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

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

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!

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

Choosing a Funding Mechanism

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.

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.

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

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

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

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

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

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.

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

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

Develop with passion and precision………

… help one another get started

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…..

California Dreamin’