Opioid use among pregnant women is increasing significantly, and consequently, a more than 5-fold increase in the incidence of neonatal abstinence syndrome (NAS) has been reported since 2000. Preliminary studies show that prenatal opioid exposure is associated with increased risk of impaired neurodevelopment across cognitive, motor and behavioral domains. Therefore, studies to rigorously characterize the impacts of prenatal opioid exposure on early brain development are critically needed. In our application, five institutions (Duke University, Arkansas Children?s Research Institute, Cincinnati Children?s Hospital, University of Illinois at Urbana-Champaign and University of North Carolina at Chapel Hill) with complementary expertise, have formed a consortium to develop strategies to prepare for the Phase II HEALthy Brain and Child Development Study, a planned large scale multi-site research study to examine the long-term impact of prenatal drug exposure on long term childhood outcomes. Leveraging the unique skills of our multidisciplinary team, we will develop essential instruments and strategies (recruitment/retention protocols, assessment batteries, and novel tools) for the Phase II study (Aim 1). We will conduct pilot studies (fetal and postnatal imaging, advanced imaging harmonization and quality control, assessment administration, biosampling) to evaluate instruments for the Phase II study (Aim 2). Finally, we will analyze available data (Aim 3), including imaging, behavioral, cognitive and maternal data from studies focusing on early brain development, to provide critical information to guide the Phase II study design. Upon completion of the proposed aims, our consortium will be in an ideal position to conduct the future Phase II study.

Public Health Relevance

Opioid use among pregnant women is increasing significantly, and some preliminary studies have shown that prenatal opioid exposure is associated with changes in the brain and impaired neurodevelopment. The NIH is planning a large research study to evaluate the brain and development in healthy children and those exposed to opioids and other substances. To prepare for this large study, we have formed a group of 5 institutions that will develop strategies, conduct pilot studies, and analyze available data to guide the future study design.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Planning Grant (R34)
Project #
3R34DA050262-01S1
Application #
10018225
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Chatterji, Minki
Project Start
2019-09-30
Project End
2021-03-31
Budget Start
2019-09-30
Budget End
2021-03-31
Support Year
1
Fiscal Year
2019
Total Cost
Indirect Cost
Name
University of North Carolina Chapel Hill
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
608195277
City
Chapel Hill
State
NC
Country
United States
Zip Code
27599