Seeking Support From the Seeking Support From the NIH for Pediatric Critical NIH for Pediatric Critical

Care ResearchCare ResearchCarol E. Nicholson, MD, MS,FAAP

NIH/NICHD/NCMRR

National National InstitutesInstitutesof Health of Health Bethesda, MDBethesda, MD

NIH consists of 27 Institutes and Centers

= Extramural only

NEI

NCI

NHLBI

NLM NINDS

NIMH

NIAMS

NINR

NCCAM

CIT

CC

NHGRI

NIANIAAA

NIAIDNICHD

NIDCD

NIDCR

NIDDK

NIDA

NIEHSOD

NIGMSNCRR

NIBIBNCMHD

FIC CSR

Advanced Technologies – New approaches to studying protein structure and function will bring great insights into the study of diseases and the design of new drugs

What will the future hold for PCCM Research?

And, Brought to you by NICHD…….• The National

Center for Medical Rehabilitation Research

• Program for Program for Pediatric Pediatric Critical Care Critical Care and and RehabilitationRehabilitation

ResearchResearch PCCRPCCR

Research Grants71%

All Other 6%

Research Management and Support 3%

IntramuralResearch

10%R&D

Contracts

7%ResearchTraining

3%

NIHNIH(FY 2001 $20.3 billion)

Over 80% of NIH funds support extramural research

www.nih.gov

The Future for Pediatric The Future for Pediatric Acute Care ResearchAcute Care Research

NIH is our Federal Government’s primary agency for support of Biomedical Research.

Funding Mechanisms

• Most $ go to investigator –Most $ go to investigator –initiated proposalsinitiated proposals

• Training• Career Development• Research Grants • Contracts

NICHD Priorities for Research

• Cells to Selves• Developmental Biology• Biobehavioral Development• Reproductive Health• Genetics of Disease Susceptiblity• Health Disparities

Relating NICHD Research Priorities• To the acutely ill and injured child who is

an outpatient: Pediatric Emergency Pediatric Emergency MedicineMedicine

• To the acutely ill and injured child who is an inpatient: Pediatric Critical Care Pediatric Critical Care MedicineMedicine

• To the increasing number of children with special needs beyond acute care:Pediatric Pediatric Rehabilitation and Physical MedicineRehabilitation and Physical Medicine

ALL pediatric subspecialties fit into the PCCR research program

• Linking what we do to outcomes for children

• Mortality is not an adequate outcome measure, in pediatric research

Cells to Selves-ICells to Selves-I• Neuroplasticity after traumatic or

asphyxial brain injury: what acute and rehabilitation strategies will:– Maximize neurodevelopmental

outcome for every child– Ensure families of injured children are

supported and not exploited

Cells to Selves-IICells to Selves-IIMaximizing Outcomes:• Breaking the guilt/blame/family

breakup cycle

Developmental BiologyDevelopmental Biology• Mechanisms of age related responses to :

– DrugsDrugs (pressors, inotropes)– SepsisSepsis (SIRS , genomics may change with

development)– VentilationVentilation (susceptibility to infection in

special needs kids)- - Ischemia and AnoxiaIschemia and Anoxia (prognosis in the

young? Rehabilitation?)– Trauma Trauma (neuroplasticity after brain injury)

Biobehavioral Development-IBiobehavioral Development-I• High Risk Behaviors: Our

adolescent trauma victims: manipulation of the young by marketing, exploitation by criminal and legitimate enterprise.

Biobehavioral Development-IIBiobehavioral Development-II• Line sepsis:Line sepsis: Compliance with complex

regimes in outpatient management of serious illness: realistic in special needs kids?

• Child Abuse and Neglect:Child Abuse and Neglect: 826,000 826,000 children were victims in 1999! Our physical findings and conclusions are constantly attacked due to inadequate supporting research.

* Child Maltreatment 1999: DHHS

Health Disparities:Health Disparities:Bridging the Gap-IBridging the Gap-I• PICU’s and ER’sPICU’s and ER’s continue to be

disproportionately populated by the poorest and sickest of children.

• Could we identify 5 diagnosesCould we identify 5 diagnoses that bring most of them to our understaffed units? Using this data to seek the assistance of policymakers.

Health Disparities;Health Disparities;Bridging the Gap-IIBridging the Gap-II• Culturally Sensitive Care: Culturally Sensitive Care: Can we

prove it reduces morbidity and mortality?

Reproductive Health for the Reproductive Health for the 2121stst Century Century• Infertility;Infertility; etiologies? Risk factors

related to health/illness events in early life?

• Maternal Lifestyle Parameters:Maternal Lifestyle Parameters: age, physical parameters, comorbidities, demographics of situations which are risk predictors for serious childhood illness and injury.

Genetics and Fetal Antecedents Genetics and Fetal Antecedents of Disease Susceptiblityof Disease Susceptiblity• Genetic polymorphisms in critical Genetic polymorphisms in critical

illness:illness: Sepsis and trauma: IL-6 responses now characterized by a polymorphism in a promoter gene:How should therapy be designed, how should triage be affected by genotype?

Heeson, Critical Care Medicine March, 2002

Targeting Sudden Infant Death Targeting Sudden Infant Death SyndromeSyndrome• Preventive StrategiesPreventive Strategies: dramatic

incidence decline initially• Pathophysiology:Pathophysiology: still poorly

understood. Genomics? • Targeted Education/Outreach:Targeted Education/Outreach:

Could the incidence be reduced to zero through preventive strategies? If not, why not?

Six Topics linking PCCM with Rehabilitation Medicine• Resuscitation Outcomes• ICU Myopathy• Near Drowning• Respiratory Failure• Shock, hypoperfusion states• Triage of Critically Ill Children

Research Project Award: R01

• Focus on specific set of aims• Investigator-initiated applications ,

usually…many exceptions• Research plan hypothesis driven• Budget: typically $150-250,000 per

year• May request up to 5 years• Renewable

Small Grants: R03 and R21

• Pilot studies; planning and feasibility; innovative, high-risk approaches

• Development of new methodology or technology

• New investigators especially encouraged

R03’s and R21’s • Not renewable• Can’t be used to supplement funded

projects• Budget: R03: $50,000/yr R21: $275,00/2 years• Please contact program staff before you

choose a funding mechanism!

SBIR/STTR in Pediatric SBIR/STTR in Pediatric Critical Care ResearchCritical Care Research

• We are proud We are proud to be gadget to be gadget freaks in the freaks in the PICU, OR, ED PICU, OR, ED or wherever or wherever the kids need the kids need innovation !innovation !

Small Business Technology Transfer (STTR, R41/42) and Small Business Innovation Research (SBIR, R43, R44)

•STTR: Phase I: $100,000 (1 year)

• Phase II: $500,000 (2 years)

•SBIR: Phase I: $100,000 (6 months)

•Phase II: $750,000 (2 years

Training and Career Development

• Individual FellowshipsGraduate students (F31) or Postdoc (F32)

• Institutional Training Grants (T32) Support graduate training, postdocs,

fellows in clinical and basic science investigation

• Career Development MechanismsEmerging basic science and clinical

investigatorsFully trained clinicians now entering

research

Loan Repayment• http://www.lrp.nih.gov/NIHLRP/

about/index.htm

Special Research Initiatives

• Request for Applications (RFA)

• Program Announcements (PA)

• Request for Proposals (RFP)

Useful NIH Websites:

• NIH Home page: www.nih.gov

• CRISP (searchable database of all

NIH-funded grants):www.commons.cit.nih.gov/crisp/

Useful NIH Websites:

• Center for Scientific Review (study section descriptions and

rosters):www.csr.nih.gov

• NIH Guide (research initiatives, policy announcements):

www.grants.nih.gov/grants/guide/index.html

What happens if……….

• My RFA responsive Application is not funded?

• The NIH Guide doesn’t solicit the kind of research I want to do?

Proposal may be resubmitted !

• As an investigator initiated proposal, new number, new or modified clock!

• Discuss with program staff: policy not yet published!

•Progress in Medicine Progress in Medicine Depends on Depends on YourYour Vision; Vision; Don’t stop making things Don’t stop making things better, EVER….better, EVER….

For Many in Acute Care Medicine, this is a New Journey

• Every journey begins with a single step

• Contact me for “Seven Steps”

• PCCR’s availability to you: “Walk Together.”

NIH/NICHD….NIH/NICHD….• Welcome your projects in the

clinical and basic sciences!• Contact us often….you will make

our day!• Carol E. Nicholson, MD, MS,

FAAP 301-435-6843 Nicholca@mail.nih.gov

California Dreamin’