Funded Projects
Explore our currently funded projects. You may search with all three fields, then focus your results by applying any of the dropdown filters. After customizing your search, you may download results and even save your specific search for later.
Project # | Project Title | Research Focus Area | Research Program | Administering IC Sort ascending | Institution(s) | Investigator(s) | Location(s) | Year Awarded |
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3U2COD023375-05S1
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ECHO ADMINISTRATIVE SUPPLEMENT - NEONATAL OPIOID TRIALS | Enhanced Outcomes for Infants and Children Exposed to Opioids | Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) | OD | Duke University | Phillip Brian Smith | Durham, NC | 2020 |
NOFO Number: N/A
Summary: Due to the opioid misuse epidemic across the nation, more infants are being exposed to narcotics during fetal life and developing neonatal opioid withdrawal syndrome (NOWS) in the neonatal period. Critical gaps remain in our knowledge with respect to best practices for identifying and managing infants with NOWS and no large-scale studies have been published on treatments undertaken and later outcomes of infants with NOWS. To address these gaps in knowledge, the Advancing Clinical Trials in Neonatal Opioid Withdrawal Syndrome (ACT NOW) study will evaluate treatment options and improve clinical care of infants with NAS/NOWS. This collaborative effort will conduct two trials: 1) Eating, Sleeping, Consoling for Neonatal Withdrawal (ESC-NOW): a Function-Based Assessment and Management Approach (ESC Study); and 2) Pragmatic, Randomized, Blinded Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS) (Weaning Study). |
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5U2COD023375-04
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MFMU Network Administrative Supplement | Enhanced Outcomes for Infants and Children Exposed to Opioids | Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) | OD | Duke University | Smith, Brian | Durham, NC | 2019 |
NOFO Title: Environmental Influences on Child Health Outcomes (ECHO) Coordinating Center (U2C)
NOFO Number: RFA-OD-16-006 |
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3R01MH107540-04S1
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FROM IRRITABILITY TO IMPAIRMENT: HOW NEURODEVELOPMENT OF EXECUTIVE FUNCTION AND PARENT-CHILD NEURAL SYNCHRONY INFLUENCE THE TRANSITION FROM NORMAL TO ABNORMAL FUNCTIONING | Enhanced Outcomes for Infants and Children Exposed to Opioids | NIMH | University of Pittsburgh at Pittsburgh | PERLMAN, SUSAN B | Pittsburgh, PA | 2018 | |
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591 Summary: The goal of this proposal is to launch an innovative, multi-modal neuroimaging program that will investigate the longitudinal trajectory of the neurodevelopment of irritability across the preschool period. Differentiating clinically salient irritability from developmentally normative temperamental variation has proven to be a difficult task. This is made even more challenging during the preschool period, when irritability has hit its normative peak and measuring neurodevelopment is impeded by methodological constraints. This research will (1) identify specific biomarkers underlying preschool vulnerability for psychopathology by examining neural maturation in executive function as a predictor for clinical outcome; and (2) examine how the parenting environment moderates this vulnerability, with the overarching objective of identifying aberrant irritable trajectories as the foundation for future brain-based behavioral intervention. Primary analyses will (1) probe underlying executive function as a predictor of clinical outcome; and (2) examine parent-child neural synchrony as a predictor of executive function maturation. |
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1R34DA050258-01
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3/3 Promoting Resilience in Children: Protocol Development for a Birth Cohort Study To Assess Factors Impacting Neurodevelopment | Enhanced Outcomes for Infants and Children Exposed to Opioids | HEALthy Brain and Child Development Study (HBCD) | NIDA | UNIVERSITY OF WISCONSIN-MADISON | ALEXANDER, ANDREW L | Madison, WI | 2019 |
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (HEALthy BCD) (Collaborative R34 Clinical Trial Not Allowed)
NOFO Number: RFA-DA-19-029 Summary: The first ten years of life are accompanied by rapid changes to the developing brain and cognitive abilities. Complex interacting factors including genetics, early-life exposure to substances, family and social interactions, and home and community environments can affect brain and cognitive development. Three linked projects aim to develop effective research protocols to lay a foundation for a future HEALthy Brain and Cognitive Development (HBCD) birth cohort study. Project 1 will develop protocols for recruitment and retention of a diverse sample of pregnant and postpartum women with oversampling of mothers with prenatal opioid use. Project 2 will identify ethical, legal, and regulatory challenges for investigations in this vulnerable population and define effective solutions to enable recruitment and study of these participants. Project 3 will develop and evaluate protocols for acquiring high-quality, quantitative neuroimaging measures with magnetic resonance imaging and functional near infrared spectroscopy and assess effective strategies for measuring cognitive performance in young children, including those exposed to opioids. |
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1U24DA055325-01
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The Healthy Brain and Child Development National Consortium Administrative Core | Enhanced Outcomes for Infants and Children Exposed to Opioids | HEALthy Brain and Child Development Study (HBCD) | NIDA | UNIVERSITY OF CALIFORNIA, SAN DIEGO | CHAMBERS, CHRISTINA (contact); NELSON, CHARLES ALEXANDER | La Jolla, CA | 2021 |
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Consortium Administrative Core (U24 - Clinical Trial Not Allowed)
NOFO Number: RFA-DA-21-022 Summary: The HEALthy Brain and Child Development National Consortium (HBCD-NC) Administrative Core (HCAC) will coordinate efforts across all sites in the HBCD-NC consortium to ensure that the consortium meets its primary objective to establish a normative model of developmental trajectories over the first 10 years of life. The HBCD-NC will collect neural, behavioral, physiological, and psychological measures, as well as biospecimens, to characterize neurodevelopmental trajectories. The HCAC will oversee study design and monitor the progress of each site’s ability to carry out a common research protocol and will assemble and distribute a comprehensive research dataset to the scientific community. This administrative core is located at the University of California, San Diego. |
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1R34DA050254-01
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Biological and Environmental Contributions to Healthy Baby Development in Diverse Population | Enhanced Outcomes for Infants and Children Exposed to Opioids | HEALthy Brain and Child Development Study (HBCD) | NIDA | CHILDREN'S HOSPITAL OF LOS ANGELES | LEVITT, PAT | Los Angeles, CA | 2019 |
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (HEALthy BCD) (R34 Clinical Trial Not Allowed)
NOFO Number: RFA-DA-19-036 Summary: This project will support consortium hypothesis generation in Phase II in order to disentangle how complex environmental factors impact brain development and function — from fetal period through the first decade — to shape cognitive, social, and emotional development. The project will develop the strategies to recruit and retain a racially and ethnically diverse sample of pregnant women (and their fetuses), who are oversampled for adverse environmental risk factors and exposure to substances of abuse; develop the strategies for managing potential legal and ethical challenges to ensure that the mother–child dyads have access to legal, social, and psychological support services as needed; and determine the optimal study protocol for the planned, phase II study — balancing the need for high quality, longitudinal data collection with the need to minimize burden on the mother–child dyads. |
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1R34DA050268-01
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4/5 Establishing Innovative Approaches for the HEALthy Brain and Child Development Study | Enhanced Outcomes for Infants and Children Exposed to Opioids | HEALthy Brain and Child Development Study (HBCD) | NIDA | CINCINNATI CHILDRENS HOSP MED CTR | MERHAR, STEPHANIE L (contact); VANNEST, JENNIFER J | Cincinnati, OH | 2019 |
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (HEALthy BCD) (Collaborative R34 Clinical Trial Not Allowed)
NOFO Number: RFA-DA-19-029 Summary: A more than 5-fold increase in the incidence of neonatal abstinence syndrome has been reported since 2000. Preliminary studies show that prenatal opioid exposure is associated with increased risk of impaired neurodevelopment. 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) have formed a consortium to develop strategies for the Phase II HEALthy Brain and Child Development Study. Research teams will develop instruments and strategies (recruitment/retention protocols, assessment batteries, and novel tools); conduct pilot studies (fetal and postnatal imaging, advanced imaging harmonization and quality control, assessment administration, biosampling) to evaluate instruments; and analyze available data, including imaging, behavioral, cognitive, and maternal data from studies on early brain development, to guide the Phase II study design. Upon completion, the consortium aims to conduct the Phase II study. |
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1R01DA059423-01
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Automated Assessment of Maternal Sensitivity to Infant Distress: Leveraging Wearable Sensors for Substance Use Disorder Prevention and Research | Enhanced Outcomes for Infants and Children Exposed to Opioids | Virtual Assessments to Understand Developmental Trajectories of Substance Use Exposure | NIDA | UNIVERSITY OF TEXAS AT AUSTIN | DE BARBARO, KAYA | Austin, TX | 2023 |
NOFO Title: HEAL Initiative: Development and validation of virtual assessments to study children and caregivers in their natural environment (R01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-23-050 Summary: High-quality parent-infant interactions set the stage for secure parent-child attachment, self-reliance, and children’s ability to flexibly solve problems and “bounce back” from difficulties. This constellation of behaviors reduces the risk of developing substance use disorders later in life. This project will develop algorithms that use data from wearable sensors, trained separately for English- and Spanish-speaking families, to assess the quality of early mother-infant interactions objectively, automatically, and remotely in natural home environments, with the goal of developing tools to facilitate identification and prevention of early risks for substance use disorders. |
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1U01DA055361-01
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13/24 The Healthy Brain and Child Development National Consortium | Enhanced Outcomes for Infants and Children Exposed to Opioids | HEALthy Brain and Child Development Study (HBCD) | NIDA | PENNSYLVANIA STATE UNIVERSITY-UNIV PARK | PEREZ-EDGAR, KORALY E (contact); ZGIERSKA, ALEKSANDRA EWA | University Park, PA | 2021 |
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-21-020 Summary: The HEALthy Brain and Child Development National Consortium (HBCD-NC) will establish a normative model of developmental trajectories over the first 10 years of life. All sites in the HBCD-NC will carry out a common research protocol and will assemble and distribute a comprehensive research dataset to the scientific community. The HBCD-NC will collect neural, behavioral, physiological, and psychological measures, as well as biospecimens, to characterize neurodevelopmental trajectories. Most participants will be recruited in the second trimester of pregnancy, with a smaller subset recruited at birth, and followed for the first 10 years of life. The Pennsylvania State University study site is in a region hard hit by opioid and methamphetamine use disorders and will recruit mother-infant pairs from largely rural communities. |
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1R34DA050237-01
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6/6 Planning for the HEALthy Early Development Study | Enhanced Outcomes for Infants and Children Exposed to Opioids | HEALthy Brain and Child Development Study (HBCD) | NIDA | UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR | BAKHIREVA, LUDMILA NICOLE (contact); LEEMAN, LAWRENCE M; STEPHEN, JULIA MARIE | Albuquerque, NM | 2019 |
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (HEALthy BCD) (Collaborative R34 Clinical Trial Not Allowed)
NOFO Number: RFA-DA-19-029 Summary: The Planning for the HEALthy Early Development Study will contribute to the design and recommended protocol for a future large-scale, multi-site research study to prospectively examine human brain, cognitive, behavioral, social, and emotional development of children beginning prenatally through ages 9–10 and to determine the impact of maternal pre- and postnatal substance use on short- and long-term development of children. The planning study will link investigators across 6 research sites who have complementary experience and expertise in the areas that are essential to designing the study. Planning activities will be accomplished using a coordinated set of 10 working groups. By the end of the planning phase, the 6 consortium sites will have produced and tested a recommended protocol for the future multi-site study and will have established feasibility of carrying out the study protocol at each of the 6 linked sites. |
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1U24DA055330-01
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Healthy Brain and Child Development National Consortium Data Coordinating Center | Enhanced Outcomes for Infants and Children Exposed to Opioids | HEALthy Brain and Child Development Study (HBCD) | NIDA | WASHINGTON UNIVERSITY | SMYSER, CHRISTOPHER DANIEL (contact); DALE, ANDERS M; FAIR, DAMIEN A | St Louis, MO | 2021 |
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Data Coordinating Center (U24)
NOFO Number: RFA-DA-21-023 Summary: The HEALthy Brain and Child Development National Consortium (HBCD-NC) Data Coordinating Center (HDCC) will provide data management and oversight to all HBCD-NC sites to ensure the consortium’s primary objective of establishing a normative template of developmental trajectories over the first 10 years of life is met. The HBCD-NC will collect neural, behavioral, physiological, and psychological measures, as well as biospecimens, to characterize neurodevelopmental trajectories. The HDCC will coordinate data collection, data quality, data harmonization, data sharing, and data analysis efforts that are central to the consortium’s ability to implement a common research protocol. The HDCC will assemble all data across the consortium sites and distribute a comprehensive and well curated research dataset to the scientific community at large. The HDCC is tightly integrated with the HEALthy Brain and Child Development Administrative Core (HCAC) and includes a multi-institution investigative team at the University of Minnesota, University of California, San Diego, and Washington University at St Louis. |
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1R34DA050262-01
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1/5 Establishing Innovative Approaches for the HEALthy Brain and Child Development Study | Enhanced Outcomes for Infants and Children Exposed to Opioids | HEALthy Brain and Child Development Study (HBCD) | NIDA | UNIV OF NORTH CAROLINA CHAPEL HILL | LIN, WEILI (contact); GILMORE, JOHN HORACE; GREWEN, KAREN M; JONES, HENDREE E | Chapel Hill, NC | 2019 |
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (HEALthy BCD) (Collaborative R34 Clinical Trial Not Allowed)
NOFO Number: RFA-DA-19-029 Summary: A more than 5-fold increase in the incidence of neonatal abstinence syndrome has been reported since 2000. Preliminary studies show that prenatal opioid exposure is associated with increased risk of impaired neurodevelopment. 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) have formed a consortium to develop strategies for the Phase II HEALthy Brain and Child Development Study. Research teams will develop instruments and strategies (recruitment/retention protocols, assessment batteries, and novel tools); conduct pilot studies (fetal and postnatal imaging, advanced imaging harmonization and quality control, assessment administration, biosampling) to evaluate instruments; and analyze available data, including imaging, behavioral, cognitive, and maternal data from studies on early brain development, to guide the Phase II study design. Upon completion, the consortium aims to conduct the Phase II study. |
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1R01DA059177-01
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Strategies to Define and Mitigate the Placental and Fetal Alterations Caused by Maternal Oxycodone Exposure | Enhanced Outcomes for Infants and Children Exposed to Opioids | The Biology of Opioid Exposure During Pregnancy and Effects on Early Neuro-Behavioral Development | NIDA | UNIVERSITY OF NEBRASKA MEDICAL CENTER | HARRIS, LYNDA KATHERINE (contact); PENDYALA, GURUDUTT N | Omaha, NE | 2023 |
NOFO Title: HEAL Initiative: Opioid Exposure and Effects on Placenta Function, Brain Development, and Neurodevelopmental Outcomes (R01 Clinical Trial Not Allowed)
NOFO Number: RFA-HD-23-033 Summary: Exposure to prescription opioids during pregnancy can alter growth of the fetus and cause persistent neurological problems during childhood. This project will identify biological underpinnings of oxycodone exposure on health of the placenta, brain development of the fetus, and behavioral problems observed in early infancy. This research will also assess whether melatonin supplementation can limit these harmful outcomes. Overall, the research aims to characterize the health effects of oxycodone used during pregnancy, as well as to point to new tools and molecular indicators (biomarkers) for diagnosing, treating, and preventing opioid harm to the fetus and mother. |
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1R01DA059422-01
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Validation of a Virtual Still Face Procedure and Deep Learning Algorithms to Assess Infant Emotion Regulation and Infant-Caregiver Interactions in the Wild | Enhanced Outcomes for Infants and Children Exposed to Opioids | Virtual Assessments to Understand Developmental Trajectories of Substance Use Exposure | NIDA | UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN | MCELWAIN, NANCY L (contact); HASEGAWA-JOHNSON, MARK ALLAN | Champaign, IL | 2023 |
NOFO Title: HEAL Initiative: Development and validation of virtual assessments to study children and caregivers in their natural environment (R01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-23-050 Summary: Both an infant’s ability to regulate their emotions and infant-parent interactions are critical to healthy brain and behavioral development. Accurate assessment of these factors for research in laboratory settings is technically difficult and burdensome for participants. Next-generation methods that can be used at home, including wearable sensors and machine learning approaches, promise to make it easier to assess infants with prenatal substance exposures. This project will use remote sensing technologies and machine learning to characterize dynamic real-time infant emotion regulation and infant-caregiver interactions throughout the day and in the home. |
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1U01DA055316-01
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16/24 Healthy Brain and Child Development National Consortium | Enhanced Outcomes for Infants and Children Exposed to Opioids | HEALthy Brain and Child Development Study (HBCD) | NIDA | UNIV OF MARYLAND, COLLEGE PARK | FOX, NATHAN A (contact); HARDEN, BRENDA J; RIGGINS, TRACY L | College Park, MD | 2021 |
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-21-020 Summary: The HEALthy Brain and Child Development National Consortium (HBCD-NC) will establish a normative model of developmental trajectories over the first 10 years of life. All sites in the HBCD-NC will carry out a common research protocol and will assemble and distribute a comprehensive research dataset to the scientific community. The HBCD-NC will collect neural, behavioral, physiological, and psychological measures, as well as biospecimens, to characterize neurodevelopmental trajectories. Most participants will be recruited in the second trimester of pregnancy, with a smaller subset recruited at birth, and followed for the first 10 years of life. The University of Maryland College Park study site is midway between Washington, DC, and Baltimore, Maryland, and will recruit a diverse sample of mother-infant pairs from across the region. |
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1R34DA050256-01
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5/5 Establishing Innovative Approaches for the HEALthy Brain and Child Development Study | Enhanced Outcomes for Infants and Children Exposed to Opioids | HEALthy Brain and Child Development Study (HBCD) | NIDA | UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN | MCELWAIN, NANCY L | CHAMPAIGN, IL | 2019 |
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (HEALthy BCD) (Collaborative R34 Clinical Trial Not Allowed)
NOFO Number: RFA-DA-19-029 Summary: A more than 5-fold increase in the incidence of neonatal abstinence syndrome has been reported since 2000. Preliminary studies show that prenatal opioid exposure is associated with increased risk of impaired neurodevelopment. 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) have formed a consortium to develop strategies for the Phase II HEALthy Brain and Child Development Study. Research teams will develop instruments and strategies (recruitment/retention protocols, assessment batteries, and novel tools); conduct pilot studies (fetal and postnatal imaging, advanced imaging harmonization and quality control, assessment administration, biosampling) to evaluate instruments; and analyze available data, including imaging, behavioral, cognitive, and maternal data from studies on early brain development, to guide the Phase II study design. Upon completion, the consortium aims to conduct the Phase II study. |
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1R01DA059152-01
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POPI: Placenta, Opioids and Perinatal Implications | Enhanced Outcomes for Infants and Children Exposed to Opioids | The Biology of Opioid Exposure During Pregnancy and Effects on Early Neuro-Behavioral Development | NIDA | UNIVERSITY OF KENTUCKY | MESSAOUDI, ILHEM (contact); O'BRIEN, JOHN M | Lexington, KY | 2023 |
NOFO Title: HEAL Initiative: Opioid Exposure and Effects on Placenta Function, Brain Development, and Neurodevelopmental Outcomes (R01 Clinical Trial Not Allowed)
NOFO Number: RFA-HD-23-034 Summary: Opioid use during pregnancy is associated with harmful health outcomes for infants including preterm birth, neonatal opioid withdrawal syndrome, and brain-related problems. This project will carry out an in-depth investigation of the effects of opioid use during pregnancy including changes to health of the placenta, inflammation in the fetus, as well as behavioral and movement-related outcomes during the first year of life. This research will contribute to fundamental knowledge about how the placenta and brain work together as well as identify new strategies for diagnosing, treating, and preventing opioid harm to the fetus and mother. |
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1R34DA050266-01
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2/2 Optimizing access, engagement and assessment to elucidate prenatal influences on neurodevelopment: The Brains Begin Before Birth (B4) Midwest Consortium | Enhanced Outcomes for Infants and Children Exposed to Opioids | HEALthy Brain and Child Development Study (HBCD) | NIDA | NORTHWESTERN UNIVERSITY AT CHICAGO | WAKSCHLAG, LAUREN S | Evanston, IL | 2019 |
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (HEALthy BCD) (Collaborative R34 Clinical Trial Not Allowed)
NOFO Number: RFA-DA-19-029 Summary: Though prenatal exposure to opioids and other substances have adverse effects on neurodevelopment, advances in neuroimaging and developmentally sensitive phenotypic measurement now enable characterization of typical and atypical brain-behavior pathways on an unprecedented scale. The Brains Begin Before Birth (B4) Midwest Consortium, a partnership of neuroscience, substance use, perinatal mental health, and child welfare scientists at Washington University School of Medicine (WUSM) and neuroscience, bioethics, pediatric population health, maternal-fetal, and addiction scientists at Northwestern University (NU). This regional consortium will leverage the contrasting approaches of Illinois (punitive) and Missouri (non-punitive) to prenatal opioid use, providing a platform for examining the impact of jurisdictional variations on science and practice. The consortium provide a framework for addressing three major areas of challenge: (1) legal/ethical, (2) recruitment/retention, and (3) imaging/assessment methods. |
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1U01DA055354-01
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20/24 The Healthy Brain and Child Development National Consortium | Enhanced Outcomes for Infants and Children Exposed to Opioids | HEALthy Brain and Child Development Study (HBCD) | NIDA | UNIVERSITY OF VERMONT & ST AGRIC COLLEGE | POTTER, ALEXANDRA S (contact); GARAVAN, HUGH P | Burlington, VT | 2021 |
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-21-020 Summary: The HEALthy Brain and Child Development National Consortium (HBCD-NC) will establish a normative template of developmental trajectories over the first 10 years of life. All sites in the HBCD-NC will carry out a common research protocol and will assemble and distribute a comprehensive and well curated research dataset to the scientific community at large. The HBCD-NC will collect neural, behavioral, physiological, and psychological measures, as well as biospecimens, to characterize neurodevelopmental trajectories. The majority of participants will be recruited in the second trimester of pregnancy, with a smaller subset recruited at birth, and followed for the first decade of life. The University of Vermont study site will recruit mother-infant dyads from a rural area in Vermont, a state in which nearly one-third of neonatal hospitalizations are for neonatal abstinence syndrome (NAS). |
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1R34DA050286-01
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The Cumulative Risk of Substance Exposure and Early Life Adversity on Child Health Development and Outcomes | Enhanced Outcomes for Infants and Children Exposed to Opioids | HEALthy Brain and Child Development Study (HBCD) | NIDA | FATHER FLANAGAN'S BOYS' HOME | BLAIR, JAMES | Boys Town, NE | 2019 |
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (HEALthy BCD) (Collaborative R34 Clinical Trial Not Allowed)
NOFO Number: RFA-DA-19-029 Summary: Despite increased efforts to understand the neurodevelopmental sequelae of in utero opioid and other substance exposure on long-term behavioral, cognitive, and societal outcomes, important questions remain, specifically, 1) How is brain growth disrupted by fetal substance and related pre- and post-natal exposures? and 2) How are these disrupted growth patterns causally related to later cognitive and behavioral outcomes? This project seeks to formulate an approach to addressing these key questions and decipher the individual and cumulative effect of these intertwined pre- and post-natal exposures on child neurodevelopment. First, researchers will address the legal, ethical, and mother-child care and support concerns implicit in this study. Next, they will integrate across our areas of neuroimaging expertise to develop, implement, and harmonize a multi-modal MRI and EEG protocol to assess maturing brain structure, function, and connectivity. Finally, researchers will develop and test advanced statistical approaches to model and analyze this multidimensional and longitudinal data. |
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1R34DA050289-01
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4/5 The Cumulative Risk of Substance Exposure and Early Life Adversity on Child Health Development and Outcomes | Enhanced Outcomes for Infants and Children Exposed to Opioids | HEALthy Brain and Child Development Study (HBCD) | NIDA | BOSTON CHILDREN'S HOSPITAL | NELSON, CHARLES ALEXANDER | Boston, MA | 2019 |
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (HEALthy BCD) (Collaborative R34 Clinical Trial Not Allowed)
NOFO Number: RFA-DA-19-029 Summary: Despite increased efforts to understand the neurodevelopmental sequelae of in utero opioid and other substance exposure on long-term behavioral, cognitive, and societal outcomes, important questions remain, specifically, 1) How is brain growth disrupted by fetal substance and related pre- and post-natal exposures? and 2) How are these disrupted growth patterns causally related to later cognitive and behavioral outcomes? This project seeks to formulate an approach to addressing these key questions and decipher the individual and cumulative effect of these intertwined pre- and post-natal exposures on child neurodevelopment. First, researchers will address the legal, ethical, and mother-child care and support concerns implicit in this study. Next, they will integrate across our areas of neuroimaging expertise to develop, implement, and harmonize a multi-modal MRI and EEG protocol to assess maturing brain structure, function, and connectivity. Finally, researchers will develop and test advanced statistical approaches to model and analyze this multidimensional and longitudinal data. |
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1R01DA059321-01
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Multimodal Fetal and Placental Imaging and Biomarkers of Clinical Outcomes in Opioid Use Disorder | Enhanced Outcomes for Infants and Children Exposed to Opioids | The Biology of Opioid Exposure During Pregnancy and Effects on Early Neuro-Behavioral Development | NIDA | INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS | RADHAKRISHNAN, RUPA | Indianapolis, IN | 2023 |
NOFO Title: HEAL Initiative: Opioid Exposure and Effects on Placenta Function, Brain Development, and Neurodevelopmental Outcomes (R01 Clinical Trial Not Allowed)
NOFO Number: RFA-HD-23-035 Summary: Opioid use during pregnancy is associated with significant harmful health outcomes for infants including preterm birth, neonatal opioid withdrawal syndrome, and impaired brain-related problems. This project will combine advanced imaging of the fetal brain and placenta, genetics, and tissue and blood samples from the placenta to determine how opioid use during pregnancy affects development of the fetal brain and placenta. This research will provide novel and early molecular indicators (biomarkers) to as well as identify new strategies for diagnosing, treating, and preventing opioid harm to the fetus and mother. |
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1R34DA050270-01
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1/3 Promoting Resilience in Children: Protocol Development for a Birth Cohort Study To Assess Factors Impacting Neurodevelopment | Enhanced Outcomes for Infants and Children Exposed to Opioids | HEALthy Brain and Child Development Study (HBCD) | NIDA | UNIVERSITY OF WISCONSIN-MADISON | GOLDSTEIN, ELLEN (contact); ZGIERSKA, ALEKSANDRA EWA | Madison, WI | 2019 |
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (HEALthy BCD) (Collaborative R34 Clinical Trial Not Allowed)
NOFO Number: RFA-DA-19-029 Summary: The first ten years of life are accompanied by rapid changes to the developing brain and cognitive abilities. Complex interacting factors including genetics, early-life exposure to substances, family and social interactions, and home and community environments can affect brain and cognitive development. Three linked projects aim to develop effective research protocols to lay a foundation for a future HEALthy Brain and Cognitive Development (HBCD) birth cohort study. Project 1 will develop protocols for recruitment and retention of a diverse sample of pregnant and postpartum women with oversampling of mothers with prenatal opioid use. Project 2 will identify ethical, legal, and regulatory challenges for investigations in this vulnerable population and define effective solutions to enable recruitment and study of these participants. Project 3 will develop and evaluate protocols for acquiring high-quality, quantitative neuroimaging measures with magnetic resonance imaging and functional near infrared spectroscopy and assess effective strategies for measuring cognitive performance in young children, including those exposed to opioids. |
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1U01DA055347-01
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6/6 HBCD Prenatal Experiences and Longitudinal Development (PRELUDE) Consortium Vanderbilt | Enhanced Outcomes for Infants and Children Exposed to Opioids | HEALthy Brain and Child Development Study (HBCD) | NIDA | VANDERBILT UNIVERSITY | CUTTING, LAURIE E (contact); OSMUNDSON, SARAH SCHEIDERICH | Vanderbilt, TN | 2021 |
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-21-020 Summary: The objective of the HBCD PRELUDE (Prenatal Experiences and Longitudinal Development) multi-site consortium is to characterize typical brain development from birth through childhood. All sites in this consortium will measure the influence of key biological and environmental factors on child social, cognitive, and emotional development. Researchers will assess how prenatal exposure to opioids and other substances, as well as other adverse environmental factors, affect brain development and other child health outcomes. The Vanderbilt University site will enroll a diverse sample of mother-infant dyads reflective of the racial, ethnic, and economic composition of the demographics of Tennessee, including rural areas dramatically affected by the opioid crisis. |
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1R34DA050263-01
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2/3 Promoting Resilience in Children: Protocol Development for a Birth Cohort Study To Assess Factors Impacting Neurodevelopment | Enhanced Outcomes for Infants and Children Exposed to Opioids | HEALthy Brain and Child Development Study (HBCD) | NIDA | UNIVERSITY OF WISCONSIN-MADISON | OSSORIO, PILAR N | Madison, WI | 2019 |
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (HEALthy BCD) (Collaborative R34 Clinical Trial Not Allowed)
NOFO Number: RFA-DA-19-029 Summary: The first ten years of life are accompanied by rapid changes to the developing brain and cognitive abilities. Complex interacting factors including genetics, early-life exposure to substances, family and social interactions, and home and community environments can affect brain and cognitive development. Three linked projects aim to develop effective research protocols to lay a foundation for a future HEALthy Brain and Cognitive Development (HBCD) birth cohort study. Project 1 will develop protocols for recruitment and retention of a diverse sample of pregnant and postpartum women with oversampling of mothers with prenatal opioid use. Project 2 will identify ethical, legal, and regulatory challenges for investigations in this vulnerable population and define effective solutions to enable recruitment and study of these participants. Project 3 will develop and evaluate protocols for acquiring high-quality, quantitative neuroimaging measures with magnetic resonance imaging and functional near infrared spectroscopy and assess effective strategies for measuring cognitive performance in young children, including those exposed to opioids. |