The purpose of this Funding Opportunity Announcement (FOA) is to seek applications for unlinked Research Project Sites for the HEALthy Brain and Child Development (HBCD) Study using the cooperative agreement award mechanism. This FOA runs in parallel with companion FOAs that seek applications for linked Research Project Sites (RFA-DA-21-020), a single Consortium Administrative Core (RFA-DA-21-022) and a single Data Coordinating Center (RFA-DA-21-023). It is expected that investigators, upon funding, will work jointly with NIH scientific staff to assist, guide, coordinate, or participate in project activities. This FOA seeks applications to create a consortium of research sites in service of the nationwide, multi-site, multi-modal, longitudinal cohort HBCD Study to prospectively examine brain and behavioral development from birth through childhood, including an emphasis on understanding the impact of in utero substance exposure on outcomes. Research sites will enroll pregnant women and collect data from them and their children using methodologies that include neuroimaging, neurophysiology, behavioral and cognitive assessments and collection of biospecimens.
The brain undergoes rapid development prenatally, through early childhood and into adolescence, supporting cognitive and emotional maturation. This rapid growth also represents a highly vulnerable period where a variety of environmental exposures can have a large and enduring impact. In utero and neonatal exposures are as likely to have significant impact on long-term health outcomes as they are likely to affect early neurodevelopment. For example, substance use during pregnancy, throughout breastfeeding, and while parenting has the potential to profoundly affect development in a variety of ways. Other environmental factors, such as exposure to environmental toxins, structural racism, SARS-CoV-2 exposure and pandemic-related stress, nutritional status, child-rearing practices, neighborhood factors, and access to healthcare, also influence physical growth and brain development. However, the relative paucity of research on normative brain development from birth through adolescence from a large, diverse cohort has limited our ability to fully understand how disruptions and experiences during early periods of growth impact individual developmental trajectories. To understand how these factors, alone and in combination, interact with genetics and other biological influences (e.g., viral exposures) to affect a child’s mental and physical health trajectory, a large prospective study is needed. To be successful, this study must include diverse populations to determine normal variability in development and factors that may disrupt it or build resilience. Additionally, the study must be of sufficient duration and scope to detect potential impact that may manifest as the child approaches school age.
Increases in substance use and ensuing harms over the past decade have heightened the urgency for understanding the complex ways in which exposure during pregnancy affects child outcomes. For example, the current opioid crisis affects the nation broadly across socio-demographic groups, with alarming increases in the use of opioids during pregnancy resulting in a sharp rise in babies born with neonatal withdrawal symptoms (8/1,000 hospital births) in the last 5-10 years. The HEAL Enhanced Outcomes for Infants and Children Exposed to Opioids initiative seeks to support research to address the medical and social needs of infants and children affected by opioid exposure and opioid use disorder. In addition, a growing body of evidence indicates that early exposure to potentially harmful substances, including pre- or perinatally, is linked to greater risk for low birth weight and preterm birth, which portend other health problems. These exposures have also been associated with altered brain structure and function early in life and with behavioral problems in childhood and adolescence, including attention deficit hyperactivity disorder (ADHD), conduct disorder, early drug use, and anxiety. Medications to treat opioid use disorder in pregnant women may mitigate opioid-related harms and improve pregnancy and child outcomes with potential gains projecting into adulthood, but the impact of those medications on neurodevelopment also remains unknown. Moreover, drug exposures during pregnancy are not limited to opioids. Marijuana, tobacco/nicotine, and alcohol are also used alone and in combination with opioids during pregnancy and reports of rising cocaine and methamphetamine use in pregnant women from some geographical areas over the last two decades, with corresponding increases in low birth weight, preterm delivery and maternal morbidity, are also worrisome. Most recently, the COVID-19 pandemic has added another layer of stress to many individuals and families and the virus itself may directly or indirectly affect neurodevelopmental outcomes. Thus, establishing causal links between early exposure to substances or other potential harms and future health and behavioral consequences is complex and will require a large prospective study of children beginning prenatally and followed into childhood. The HEALthy Brain and Child Development (HBCD) Study, is being established to provide a detailed characterization of brain development (using neuroimaging and physiological tools), genetics, social, behavioral, and other biological/environmental contexts to understand neurodevelopmental trajectories. Data collected on this cohort will be made widely available to the scientific community.
To provide an index of normative child development and to address critical questions surrounding the long-term impact of high-risk environments, including substance exposure, HBCD seeks to enroll a large, diverse cohort of pregnant women, who, along with their children, will be followed longitudinally. The cohort will consist of mother and baby dyads recruited beginning in the 2nd trimester of pregnancy and through birth. While a majority of the cohort is expected to be recruited from the general population of pregnant women, a subset will include pregnant women whose babies were exposed pre- or perinatally to prescription and illicit opioids, marijuana, stimulants, alcohol and tobacco/nicotine; as well as women from comparable high risk environments, who did not use substances during pregnancy. Advances in neuroimaging, bioinformatics, and genetic technologies (among others) will enable the collection of multi-modal data that will be made available on an ongoing basis (approximately annually) to the wider research community for timely analysis and as a long-term resource for studying neurodevelopment and other health outcomes. A deep, nuanced understanding of factors that affect a child’s health, brain and behavioral development is expected to emerge from this study, which is an essential first step toward designing policies and interventions that promote well-being and resilience in all children.
For additional information on the planning phase for the HEALthy Brain and Child Development Study, please see the summary reports from expert panel meetings, PI meetings, and neuroimaging and biospecimen workgroups at HBCD Study.
URL for more information:
Please contact Dr. Driscoll (dld5dt) if you are considering an application to one of these RFAs.
Filed Under: Funding Opportunities