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

项目总结 实验动物在生命早期接触到大多数麻醉剂和镇静剂药物后会发生变化 会干扰记忆、学习和行为的大脑和神经系统。 在幼儿身上积累的临床数据表明行为有改变，但认知没有改变 在单次和多次曝光中，但需要更多数据来进一步回答这些问题 与麻醉剂神经毒性有关。 这个为期一年的项目将继续进行中的工作，以促进知识和 了解麻醉剂对发育中的大脑的影响，包括识别和 支持临床前和临床研究，以解决当前的未知问题。它还将 为医疗保健提供者和公众提供稳定的信息流 这一领域的发展和研究成果以及对临床实践和 公共卫生。 FDA正在考虑在2021-22年联邦政府结束时结束SmartTots PPP 财政年度，并将SmartTots与ACTTION PPP合并。这一年课程的一个关键要素 该项目将绘制与当前ACTTION计划重叠的区域并确定 在合并事件中继续推进SmartTots工作的战略 使用ACTTION。SmartTots和ACTTION已经开始讨论探索以下可能性 共同努力，履行他们共同的使命。 该项目旨在实现以下目标：支持和协助 FDA及其利益攸关方在实现SmartTots PPP目标方面的作用，包括但不限于 致： 1.维护和进一步发展行政和科学基础设施，以支持 在FDA儿科协会的主持下创建和执行一系列项目 麻醉安全倡议(PASI)。 2.根据FDA的同意，制定实施已确定的研究项目的计划， 包括确定、保护和利用已确定项目的其他资源， 传播项目成果和建议，并提出相关研究。 3.与麻醉和医疗领域的关键专家进行协作、协调和交流 神经科学，包括来自专业组织、学术界、 政府和工业界，通过科学研讨会、出版物、宣传和其他 活动。 4.协调研究成果的翻译，用于未来的研究、临床实践和 了解对公众健康的影响。

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.