The Strategies for Mitigating Anesthesia-Related neuroTotxicity in Tots (SmartTots) Public-Private Partnership (PPP) is developing, implementing, and managing an administrative and a scientific infrastructure to support the creation and execution of a strategic series of research projects aligned with the Pediatric Anesthesia Safety Initiative (PASI). Objectives SmartTots 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). This governance board aims to ensure appropriate implementation, management, and oversight for all scientific projects under the PPP. The objectives of SmartTots are as follows: 1) continue to develop and execute a strategy to identify and establish relationships with key experts in the fields of anesthesia and sedation, including stakeholders from professional organizations, industry, and academia;2) coordinate scientific workshops in collaboration with the Food and Drug Administration (FDA) and with multiple stakeholders;and 3) coordinate the development and publication of articles in support of educational and outreach activities with FDA and other partners. Methods To 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 and its stakeholders in developing and implementing a strategy to achieve the goals of the PASI Initiative, including the planning of and participation in workshops, development of a strategic plan, and providing recommendations for organizing the FDA and other stakeholder team(s);and 3) select, fund, and oversee multiple research studies, as agreed to by the PPP SAB and SC. Funded studies will support strategic goals and will provide 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.

National Institute of Health (NIH)
Food and Drug Administration (FDA)
Research Project--Cooperative Agreements (U01)
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International Anesthesia Resear/ Society
San Francisco
United States
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