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

> **NIH FDA U01** · INTERNATIONAL ANESTHESIA RESEAR/ SOCIETY · 2020 · $200,000

## Abstract

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.

## Key facts

- **NIH application ID:** 9984966
- **Project number:** 5U01FD005935-05
- **Recipient organization:** INTERNATIONAL ANESTHESIA RESEAR/ SOCIETY
- **Principal Investigator:** EMERY N BROWN
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2020
- **Award amount:** $200,000
- **Award type:** 5
- **Project period:** 2016-09-15 → 2021-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9984966

## Citation

> US National Institutes of Health, RePORTER application 9984966, A Public-Private Partnership to support the investigation of anesthesia-related neurotoxicity in the pediatric population through non-clinical and clinical studies. (5U01FD005935-05). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/9984966. Licensed CC0.

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