# 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 · 2021 · $446,574

## 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, 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.

## Key facts

- **NIH application ID:** 10410115
- **Project number:** 1U01FD007468-01
- **Recipient organization:** INTERNATIONAL ANESTHESIA RESEAR/ SOCIETY
- **Principal Investigator:** Dean B. Andropoulos
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2021
- **Award amount:** $446,574
- **Award type:** 1
- **Project period:** 2021-09-01 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10410115

## Citation

> US National Institutes of Health, RePORTER application 10410115, A Public-Private Partnership to support the investigation of anesthesia-related neurotoxicity in the pediatric population through non-clinical and clinical studies. (1U01FD007468-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10410115. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*