# HEAL Initiative: Antenatal Opioid Exposure Longitudinal Study Consortium

> **NIH NIH RL1** · CHILDREN'S HOSP OF PHILADELPHIA · 2020 · $1

## Abstract

Opioid use during pregnancy is a national epidemic. Prenatal opioid exposure occurs at a time of rapid fetal
brain development, and may cause important long-term structural and functional neurologic problems in the
exposed child. However, children with prenatal opioid exposure are also often exposed to maternal mental
health problems, poor parenting, and adverse home environments. It is critical to determine the relative
impacts of multiple adverse exposures on childhood outcomes and identify potentially modifiable factors.
The goal of the Outcomes of Babies with Opioid Exposure (OBOE) study is to characterize the
multidimensional impact of prenatal opioid exposure and to identify modifiable risk factors for adverse sequelae
in order to optimize neurodevelopmental, behavioral, and family outcomes. Specific aims are: (1) To determine
the impact of prenatal opioid exposure on brain structure and connectivity over the first 2 years of life, (2) To
define medical, developmental, and behavioral outcomes over the first 2 years of life in infants exposed to
opioids, and (3) To 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, family and environmental factors interact with prenatal opioid exposure to influence the
trajectories of connectivity, development, and behavior over the first 2 years of life. To test this hypothesis,
our consortium will enroll 200 opioid exposed infants and 75 healthy appropriately matched controls in a
multicenter longitudinal cohort study. We will assess brain volumes and structural and functional
connectivity by MRI at 2 weeks, 6 months, and 24 months and behavior and development at 12 and 24
months. The home environment will be assessed with a standardized tool at 12 months.
Our consortium consists of a Data Coordinating Center at RTI and four Clinical Sites, all of whom have
extensive experience collaborating in multicenter longitudinal pediatric research. Study team members
have significant expertise in longitudinal neonatal follow-up, epidemiology, clinical trials, health
disparities, neuroimaging, and NOWS. The Clinical Site at CHOP/PENN brings essential expertise in
longitudinal follow-up of high-risk populations, advanced statistical methods such as causal inference,
serial neuroimaging in infants and toddlers, and exceptional track records of recruitment and retention in
neonatal clinical research to the OBOE consortium, ensuring success of this important study.

## Key facts

- **NIH application ID:** 10141386
- **Project number:** 1RL1HD104252-01
- **Recipient organization:** CHILDREN'S HOSP OF PHILADELPHIA
- **Principal Investigator:** Sara Bonamo DeMauro
- **Activity code:** RL1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1
- **Award type:** 1
- **Project period:** 2019-10-01 → 2024-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10141386

## Citation

> US National Institutes of Health, RePORTER application 10141386, HEAL Initiative: Antenatal Opioid Exposure Longitudinal Study Consortium (1RL1HD104252-01). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10141386. Licensed CC0.

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