The Strategies for Mitigating Anesthesia-Related neuroTotxicity in Tots (SmartTots)Public-Private Partnership (PPP) is developing, implementing, and managing anadministrative and a scientific infrastructure to support the creation and execution of astrategic series of research projects aligned with the Pediatric Anesthesia SafetyInitiative (PASI).ObjectivesSmartTots will continue to coordinate and develop an overall governance board,including a Steering Committee (SC), Executive Board (EB), Scientific Advisory Board(SAB), Affiliate Advisory Council (AAC), and Industry Advisory Council (IAC). Thisgovernance board aims to ensure appropriate implementation, management, andoversight for all scientific projects under the PPP. The objectives of SmartTots are asfollows: 1) continue to develop and execute a strategy to identify and establishrelationships with key experts in the fields of anesthesia and sedation, includingstakeholders from professional organizations, industry, and academia; 2) coordinatescientific workshops in collaboration with the Food and Drug Administration (FDA) andwith multiple stakeholders; and 3) coordinate the development and publication of articlesin support of educational and outreach activities with FDA and other partners.MethodsTo support and assist the FDA and its stakeholders in achieving the goals of PASI,SmartTots will: 1) plan and organize work effort to support PASI; 2) assist the FDA andits stakeholders in developing and implementing a strategy to achieve the goals of thePASI Initiative, including the planning of and participation in workshops, development ofa strategic plan, and providing recommendations for organizing the FDA and otherstakeholder team(s); and 3) select, fund, and oversee multiple research studies, asagreed to by the PPP SAB and SC. Funded studies will support strategic goals and willprovide results and recommendations in alignment with the objectives of PASI.

Public Health Relevance

Children do not undergo surgery requiring anesthesia unless that procedure is essential to their health. It is therefore generally not an option to delay surgery until the child is older than four years. Thus, it is vital that doctors possess the most current information with regards to the safe use of available anesthetics in pediatric patients. The SmartTots initiative aims to improve the safety of anesthetic use for neonatal and infant patients by undertaking the following: 1) establish which of the anesthetics currently in common use are safest for children younger than four years;2) establish the safest effective dosage, treatment time, and allowable number of doses for each anesthetic;3) utilize this information to create new guidelines for doctors;and 4) release all data and conclusions into the public domain.

Agency
National Institute of Health (NIH)
Institute
Food and Drug Administration (FDA)
Type
Research Project--Cooperative Agreements (U01)
Project #
1U01FD004184-01
Application #
8263010
Study Section
Special Emphasis Panel (ZFD1-SRC (99))
Project Start
2011-09-15
Project End
2016-08-31
Budget Start
2011-09-15
Budget End
2012-08-31
Support Year
1
Fiscal Year
2011
Total Cost
Indirect Cost
Name
International Anesthesia Resear/ Society
Department
Type
DUNS #
097625685
City
San Francisco
State
CA
Country
United States
Zip Code
94111