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

公私合作伙伴关系，通过非临床和临床研究支持儿科人群麻醉相关神经毒性的调查。

• 批准号: 10410115
• 负责人: Dean B. Andropoulos
• 金额: $ 44.66万
• 依托单位: INTERNATIONAL ANESTHESIA RESEAR/ SOCIETY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10410115
• 关键词: Public; Private; Partnership; support; investigation

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.

项目摘要 实验动物在生命早期暴露于大多数麻醉剂和镇静剂药物后， 影响大脑和神经系统，影响记忆、学习和行为。 在幼儿中积累的临床数据表明，行为发生了改变，但认知没有改变。 但需要更多的数据来进一步回答这些问题 与麻醉神经毒性有关。 这个为期一年的项目将继续进行中的工作，以促进知识和 了解麻醉剂对大脑发育的影响，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关于新的 这一领域的发展和研究成果及其对临床实践的影响， 公共卫生 FDA正在考虑在2021-22年联邦 并将SmartTots与ACTTION PPP合并。这一年的一个关键因素 该项目将绘制与当前ACTTION计划重叠的区域，并确定 在合并情况下继续推进SmartTots工作的战略 与行动。SmartTots和ACTTION已经开始讨论，探索 共同完成他们共同的使命。 该项目旨在实现以下目标：支持和协助 FDA及其利益相关者在实现SmartTots PPP目标方面的作用，包括但不限于 收件人： 1.维持和进一步发展行政和科学基础设施， 在FDA儿科研究中心的支持下，创建和执行一系列项目 麻醉安全倡议（PASI）。 2.按照FDA的同意，制定已确定的研究项目的实施计划， 包括为所识别的项目识别、保护和利用其他资源， 传播项目成果和建议，并提出相关研究建议。 3.与麻醉领域的主要专家合作，协调和沟通， 神经科学，包括来自专业组织，学术界， 政府和工业界，通过科学讲习班、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 了解对公共卫生的影响。