National National Pediatric Critical Care Pediatric Critical Care Collaborative Research NetworkCollaborative Research Network

Carol E. Nicholson, MDNIH/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 In survivors of childhood critical

illness….illness…. Linking outcomes (functional and Linking outcomes (functional and

developmental) to critical illness developmental) to critical illness and its managementand its management

Minimizing the effect on siblings Minimizing the effect on siblings and families of devastating and families of devastating childhood illnesschildhood illness

Reintegration of child into home, Reintegration of child into home, school, family as the ultimate goal school, family as the ultimate goal of critical care practiceof critical care practice

In the subspecialty….In the subspecialty….

Understanding the pathophysiology Understanding the pathophysiology of critical illness, particularly multiple of critical illness, particularly multiple organ system failure (MOSF)organ system failure (MOSF)

Evaluating practice: our own, other Evaluating practice: our own, other specialties caring for children.specialties caring for children.

Finding adequate outcome measures Finding adequate outcome measures of pediatric critical care practiceof 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…….The Money……. Total amount of Total amount of

“set-aside”: $5M “set-aside”: $5M (years 2-5)(years 2-5)

$1M Data $1M Data Coordinating Center Coordinating Center (separate RFA)(separate RFA)

To fund core clinical To fund core clinical centers: $4Mcenters: $4M

How much each, for what?How much each, for what?

Infrastructure operating costs:Infrastructure operating costs: Each center: direct costs:Each center: direct costs: First year $100,000First year $100,000 Years 2-5 $450,000Years 2-5 $450,000

Full time research nurseFull time research nurse 10-15% PI time10-15% PI time Half time data entry /administrative Half time data entry /administrative

staffstaff

To qualify, these To qualify, these centers centers MUST…..MUST…..

HAVE STRONG HAVE STRONG FOLLOWUPFOLLOWUP of of CHILDREN who CHILDREN who have devastating have devastating illness or injuryillness or injury

Your longer term Your longer term care colleagues care colleagues are looking for are looking for you….you….get get involved!involved!

Governance of the Governance of the NetworkNetwork

Steering Steering CommitteeCommittee

consists of:consists of: PI’s PI’s NICHD Project NICHD Project

ScientistScientist DCC PIDCC PI Chairman (NICHD Chairman (NICHD

appointed)appointed)

Choosing a Funding Choosing a Funding MechanismMechanism

What is a Cooperative Agreement?

Substantial NICHD scientific Substantial NICHD scientific and/or programmatic involvement and/or programmatic involvement with the recipient is with the recipient is anticipatedanticipated..

An award instrument establishing An award instrument establishing an "assistance relationship” an "assistance relationship” between the NIH institutes between the NIH institutes (NICHD) and a recipient.(NICHD) and a recipient.

To Clarify, a bit….To Clarify, a bit….

NICHD’s purpose in this NICHD’s purpose in this relationship :relationship :

to support and/or stimulate the to support and/or stimulate the recipient's activity by recipient's activity by involvement in and otherwise involvement in and otherwise facilitating the activity in a facilitating the activity in a "partner" role"partner" role

avoid a dominant role, direction, avoid a dominant role, direction, or prime responsibility.or prime responsibility.

How will applicants be How will applicants be evaluated?evaluated?

Three areasThree areas Characteristics of the Proposed Characteristics of the Proposed

CenterCenter Principal Investigator and Principal Investigator and

Identified Research NurseIdentified Research Nurse Proposed ScienceProposed Science

Review of ApplicationsReview of Applications

CRITERIACRITERIA include: include:

SignificanceSignificance ApproachApproach InvestigatorInvestigator EnvironmentEnvironment

Additional Review Criteria in Additional Review Criteria in RFA…RFA…

The review will be by a The review will be by a “SEP”“SEP”

Special Emphasis Panel, convened Special Emphasis Panel, convened by NICHD just for this purpose.by NICHD just for this purpose.

The Scientific Review The Scientific Review Administrator will select and invite Administrator will select and invite the review committee membersthe review committee members

Not all members of the review Not all members of the review group will be intensivistsgroup will be intensivists

Looking at the three aspects of Looking at the three aspects of

thethe application to be submittedapplication to be submitted

A paradigm: A paradigm: preparing to preparing to board the trainboard the train

Is it the right train Is it the right train for you?for you?

Don’t get on the Don’t get on the train to New York train to New York if you want to get if you want to get to Kansas Cityto Kansas City

Characteristics of the Characteristics of the CenterCenter

A table of the A table of the characteristics of characteristics of your pediatric your pediatric critical care critical care service:service:

# of patients in # of patients in each categoryeach category

Institutional Institutional personnel and personnel and servicesservices

Principal Investigator and Principal Investigator and Research NurseResearch Nurse

Evidence of commitment to researchEvidence of commitment to research Evidence of commitment to Evidence of commitment to

collaborationcollaboration Research Nurse must be identified at Research Nurse must be identified at

the time of applicationthe time of application Each Principal Investigator must be a Each Principal Investigator must be a

fully qualified pediatric intensivist.fully qualified pediatric intensivist.

Don’t let the timing bother Don’t let the timing bother you….you….

Publication: April, Publication: April, 20042004

Applications due Applications due August 9, 2004August 9, 2004

Anticipated Anticipated funding Spring, funding Spring, 20052005

……..Summer, 2004..Summer, 2004 Due date August, Due date August,

20042004 start now, so that start now, so that

summer is summer is peaceful, and the peaceful, and the Network Network applications begin applications begin to………to………

Develop with passion Develop with passion and precision………and precision………

… … help one another get help one another get startedstarted

Things to do first!Things to do first!

Identify research nurse and princicpal Identify research nurse and princicpal investigatorinvestigator

Get buy-in at your institution….is this Get buy-in at your institution….is this the right train for you? Ask the neos…the right train for you? Ask the neos…

Identify the science you will propose Identify the science you will propose and begin the SEVEN STEPS…make your and begin the SEVEN STEPS…make your notebooknotebook

You will need to know ages and You will need to know ages and diagnostic categories of PICU diagnostic categories of PICU patients…..patients…..

California Dreamin’California Dreamin’