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，会出现 大脑和神经系统会干扰记忆和学习。数据不足，无法 支持或驳斥这样一种可能性，即受感染的幼儿可能会产生类似的影响 麻醉剂。 这个项目将促进对麻醉药对心脏的影响的认识和理解。 通过一系列临床前研究开发大脑，其结果将最终告知 一个或多个主要临床试验的设计。它还将为以下方面提供稳定的信息流 医疗保健提供者和公众关于这一领域的新发展和研究成果以及 对临床实践和公共卫生的影响。 该项目旨在实现以下目标： (1)为SmartTots Public-Private提供行政、管理和战略支持 合作伙伴关系(PPP)，以协助FDA及其利益攸关方实现儿科 麻醉安全倡议(PASI)。 (2)为系列片的创作和实施提供科学基础设施和专家支持 在SmartTots公私伙伴关系下与实现PASI目标保持一致的项目。 (3)确定研究方向，确定临床前和临床终点，签约 监督一系列研究，以促进临床前和临床对阿司匹林疗效的了解 麻醉剂和镇静剂对发育中的大脑。 (4)协调研究成果的转化，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 and learning. There is not enough data to support or refute the possibility that similar effects could occur in young children exposed to anesthetics. This project will advance the knowledge and understanding of the effects of anesthetics on the developing brain through a series of preclinical studies, the results of which will ultimately inform the design of one or more major clinical trials. 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 project is designed to accomplish the following objectives: (1) Provide the administrative, management, and strategic support for the SmartTots Public-Private Partnership (PPP) to assist the FDA and its stakeholders in achieving the goals of the Pediatric Anesthesia Safety Initiative (PASI). (2) Provide the scientific infrastructure and expert support for the creation and execution of a series of projects under the SmartTots PPP aligned with achieving the goals of the PASI. (3) Determine the research direction, identify the preclinical and clinical endpoints, contract for, and oversee a series of studies to advance the preclinical and clinical knowledge about the effects of anesthetics and sedatives on the developing brain. (4) Coordinate the translation of research outcomes for future studies, clinical practice, and an understanding of the implications for public health.