HEALthy Brain and Child Development Study

Overview

The Research Need

The first few years of life are a period of exponential brain growth and development. The effects of early exposure to opioids on infant and child development are unknown.

To address this knowledge gap, NIH is supporting research to better understand typical brain development, beginning in the prenatal period and extending through early childhood, including variability in development and how it contributes to cognitive, behavioral, social, and emotional function. Knowledge of normative brain trajectories is critical to understanding how brain development may be affected by exposure to opioids and other substances (e.g., alcohol, tobacco, cannabis), stressors, trauma, and other significant environmental influences, including those that promote resilience.

About the Program

The HEALthy Brain and Child Development (HBCD) Study will establish a large cohort of pregnant women from regions of the country significantly affected by the opioid crisis and follow them and their children for at least 10 years. Findings from this cohort will help researchers understand normative childhood brain development as well as the long-term impact of prenatal and postnatal opioid and other drug and environmental exposures.

The study will collect data on pregnancy and fetal development; infant and early childhood structural and functional brain imaging; anthropometrics; medical history; family history; biospecimens; and social, emotional and cognitive development.

Knowledge gained from this research will be critical to help predict and prevent some of the known effects of prenatal and postnatal exposure to certain drugs or environmental exposures, including risk for future substance use, mental disorders, and other behavioral and developmental problems.

Program Details

Phase I of the HBCD Study will be an 18-month planning phase during which awardees will test the experimental design and feasibility of approaches. Awardees will conduct multisite pilot and feasibility studies addressing four key areas that are crucial for the Phase II study:

  • Recruitment and retention strategies
  • Ethical and legal considerations
  • Imaging technologies
  • Other assessment methodologies

This planning phase will help ensure a robust study design for the Phase II HBCD Study, which is expected to launch in 2021. In Phase II, a fully integrated, collaborative infrastructure will support the collection of a large dataset that will enable researchers to analyze brain development in opioid-exposed and non-drug-exposed infants and children across a variety of regions and demographics.

Research Examples

Examples of HBCD activities include:

  • Optimizing assessment (e.g., neurocognitive testing) and imaging techniques (e.g., magnetic resonance imaging [MRI]) from prenatal stages through childhood
  • Developing standardized analysis pipelines for imaging and behavioral and cognitive testing
  • Using real-time MRI to analyze brain development
  • Testing alternative brain imaging techniques, such as functional near-infrared spectroscopy
  • Testing the feasibility of wearable technology to track parent-child interactions and child physiology
  • Assessing other factors likely to affect early development, such as HIV status, socioeconomic status, neighborhood factors, and family stability
  • Considering various levels of opioid and other drug exposures alone and in combination
  • Developing recruitment and retention protocols that focus on enrolling a diverse group of pregnant and postpartum women, including mothers with prenatal opioid use
  • Establishing community advisory boards comprising medical providers, patient advocates, ethicists, and representatives from state agencies to inform the study design, especially as it relates to ethical, legal or social issues in vulnerable populations

  • Arkansas Children’s Hospital Research Institute – Arkansas
  • Avera McKennan Hospital & University Health Center – South Dakota
  • Boston Children’s Hospital – Massachusetts
  • Case Western Reserve University – Ohio
  • Cedars-Sinai Medical Center – California
  • Children’s Hospital of Los Angeles – California
  • Cincinnati Children’s Hospital Medical Center – Ohio
  • Duke University – North Carolina
  • Emory University – Georgia
  • Father Flanagan’s Boys’ Home – Nebraska
  • Johns Hopkins University – Maryland
  • Mt. Sinai School of Medicine – New York
  • New York University School of Medicine – New York
  • Northwestern University – Illinois
  • Oklahoma State University Center for Health Sciences – Oklahoma
  • Oregon Health & Science University – Oregon
  • University of California, San Diego – California
  • University of Florida – Florida
  • University of Illinois at Urbana-Champaign – Illinois
  • University of Maryland – Maryland
  • University of New Mexico Health Sciences Center – New Mexico
  • University of North Carolina, Chapel Hill – North Carolina
  • University of Pennsylvania – Pennsylvania
  • University of Pittsburgh – Pennsylvania
  • University of Vermont – Vermont
  • University of Wisconsin-Madison – Wisconsin
  • Washington University – Missouri
  • Women & Infants Hospital in Rhode Island – Rhode Island

Funded Projects

2019
1/2 Optimizing access, engagement and assessment to elucidate prenatal influences on neurodevelopment: The Brains Begin Before Birth (B4) Midwest Consortium
Sep 25, 2019
2019
1/3 Promoting Resilience in Children: Protocol Development for a Birth Cohort Study To Assess Factors Impacting Neurodevelopment
Sep 25, 2019
2019
1/4 Investigation of opioid exposure and neurodevelopment (iOPEN)
Sep 25, 2019
2019
1/5 Establishing Innovative Approaches for the HEALthy Brain and Child Development Study
Sep 25, 2019
2019
The Cumulative Risk of Substance Exposure and Early Life Adversity on Child Health Development and Outcomes
Sep 25, 2019