# Administrative Supplement for ACT NOW OBOE Longitudinal Study

> **NIH NIH PL1** · RESEARCH TRIANGLE INSTITUTE · 2020 · $800,000

## Abstract

PROJECT SUMMARY/ABSTRACT
DESCRIPTION: See instructions. This must contain a summary of the proposed activity suitable for dissemination to the public (no
proprietary/confidential information). It should be a self-contained description of the project and contain a statement of objectives and methods to be
employed. It should be informative to other persons working in the same or related fields. DO NOT EXCEED THE SPACE PROVIDED.
Although the health, social, and economic impacts of opioid addiction on adults and their communities are
well known, the impact of maternal opioid use and misuse on the fetus exposed in utero is less well
understood. The ACT NOW Outcomes of Babies with Opioid Exposure (OBOE) Study is a longitudinal
cohort study to prospectively examine the medical, neuroanatomical, neurodevelopmental, behavioral, and
social/family/home outcomes of children who were exposed to opioids in utero as compared with matched
controls. The objectives of the ACT NOW OBOE Study are (1) to determine the impact of antenatal opioid
exposure on brain structure and connectivity over the first 2 years of life; (2) define medical,
developmental, and behavioral outcomes over the first 2 years of life in infants exposed to opioids; and
(3) explore whether and how the home environment, maternal mental health, and parenting modify
trajectories of brain connectivity and neurodevelopment over the first 2 years of life. We hypothesize that
neural connectivity and neuroanatomical volumes are altered by prenatal opioid exposure and that the
magnitude of these alterations correlate with developmental and behavioral outcomes. Further, maternal and
environmental factors interact with prenatal opioid exposure to influence the trajectories of connectivity,
development, and behavior over the first 2 years of life. The OBOE Study Consortium includes four Clinical
Sites (Case Western Reserve University, Children's Hospital of Philadelphia, Cincinnati Children's Hospital
Medical Center, and the University of Alabama at Birmingham) and an independent Data Coordinating
Center at RTI International, composed of an Administrative Core and a Research Support Core. The
consortium also includes a Neuroimaging Core at the Children's National Hospital, which has an extensive
track record of studying brain development in healthy and high-risk fetuses, newborns, and infants using
advanced, serial, multimodal magnetic resonance imaging methods. The goals of this administrative
supplement to the ACT NOW OBOE Study are (1) to increase the sample size for the study, thereby
improving the statistical power to detect differences in outcomes, particularly categorical and/or less common
outcomes, between opioid-exposed and unexposed infants; and (2) to include additional measures of infant
sleep and caregiver–infant interactions to allow for harmonization with other ACT NOW studies.

## Key facts

- **NIH application ID:** 10130155
- **Project number:** 3PL1HD101059-01S1
- **Recipient organization:** RESEARCH TRIANGLE INSTITUTE
- **Principal Investigator:** CARLA M BANN
- **Activity code:** PL1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $800,000
- **Award type:** 3
- **Project period:** 2019-09-20 → 2024-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10130155

## Citation

> US National Institutes of Health, RePORTER application 10130155, Administrative Supplement for ACT NOW OBOE Longitudinal Study (3PL1HD101059-01S1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10130155. Licensed CC0.

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