A Public-Private Partnership to support the investigation of anesthesia-related neurotoxicity in the pediatric population through non-clinical and clinical studies.

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PROJECT SUMMARY Laboratory animals exposed to most anesthetic and sedative drugs early in life show changes to the brain and nervous system that can interfere with memory, learning, and behavior. Accumulating clinical data in young children suggest alterations in behavior but not cognition in single and multiple exposures, but more data is needed to further answer the questions related to anesthetic neurotoxicity. This one-year project will continue the work in progress to advance the knowledge and understanding of the effects of anesthetics on the developing brain, including identifying and supporting studies, both preclinical and clinical, that will address current unknowns. It will also provide a steady stream of information for healthcare providers and the public on new developments and research findings in this area and the implications for clinical practice and public health. The FDA is considering ending the SmartTots PPP at the conclusion of the 2021-22 federal fiscal year and merging SmartTots with the ACTTION PPP. A key element of this one-year project will be to map the areas of overlap with the current ACTTION program and identify strategies to continue the forward movement of the SmartTots work in the event of a merger with ACTTION. SmartTots and ACTTION have begun discussions to explore possibilities for working together to carry out their shared mission. The project is designed to accomplish the following objectives of supporting and assisting the FDA and its stakeholders in achieving the goals of the SmartTots PPP, including but not limited to: 1. Maintain and further develop the administrative and scientific infrastructure to support the creation and execution of a series of projects under the auspices of the FDA Pediatric Anesthesia Safety Initiative (PASI). 2. Develop plans for the conduct of identified research projects, as agreed to by the FDA, including identifying, securing, and leveraging other resources for the identified projects, disseminating project results and recommendations, and proposing related studies. 3. Collaborate, coordinate, and communicate with key experts in the fields of anesthesia and neuroscience, including stakeholders from professional organizations, academia, government, and industry, through scientific workshops, publications, advocacy, and other activities. 4. Coordinate the translation of research outcomes for future studies, clinical practice, and an understanding of the implications for public health.