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 Institution(s) Investigator(s) Location(s) Year Awarded
1R01DA059423-01
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.

1R01DA059422-01
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.

1R01DA059415-01
Integrating Eye-Tracking and ECG Methodologies for Remote Infant Neurocognitive Assessments in the Home Enhanced Outcomes for Infants and Children Exposed to Opioids Virtual Assessments to Understand Developmental Trajectories of Substance Use Exposure NIDA NEW YORK UNIVERSITY BRITO, NATALIE HIROMI New York, NY 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:

Use of remote data collection in developmental research can make it easier for families to participate in such research and increase sociodemographic diversity of participants. The goal of this project is to validate remote methods for testing early cognitive development, particularly attention and memory skills, in 4-, 8-, and 12-month-old infants from traditionally underrepresented populations in neuroscience research. The project will integrate multiple types of data to improve remote measurement of infant cognition within the home and will help expand understanding of developmental trajectories and mechanisms across diverse environments and contexts.

1R01HD113032-01
Predicting Neonatal Health Outcomes From Placental and Fetal Brain Extracellular Vesicles in Pregnant Opioid Users Enhanced Outcomes for Infants and Children Exposed to Opioids The Biology of Opioid Exposure During Pregnancy and Effects on Early Neuro-Behavioral Development NICHD UNIVERSITY OF WASHINGTON VOJTECH, LUCIA N (contact); CHIU, DANIEL T Seattle,WA 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-23-037
Summary:

Opioid use during pregnancy is associated with significant harmful health outcomes for infants including preterm birth, neonatal opioid withdrawal syndrome (NOWS), and impaired brain-related problems. Not all infants exposed to opioids develop NOWS, and there is a need for better diagnostic tests. This project will study specialized cell structures called vesicles that are released from the placenta, fetal brain, and central nervous system to communicate information about health of the fetus and placenta. This research on vesicles will be combined with data about NOWS diagnosis up to 1 month after birth. The research aims to generate molecular indicators (biomarkers) that predict which newborns develop NOWS, toward guiding safe and effective treatment for these newborns.

5U24DA055325-02
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 2023
NOFO Title: Notice of Special Interest (NOSI): HEAL Initiative: Biospecimen Collection in Pregnancy
NOFO Number: NOT-DA-23-005
Summary:

Opioid use during pregnancy is associated with adverse outcomes for pregnant individuals and offspring. The mechanisms through which these outcomes arise and the consequences of prenatal opioid exposure on child health and development remain largely unexplored. The HEALthy Brain and Child Development (HBCD) Study is a nationwide longitudinal prospective study of early child development that will assess a broad spectrum of biological, behavioral, social, and health factors among 7,500 pregnant women and their children from pregnancy to mid-childhood. This supplement will expand the biospecimen collection of the HBCD protocol at the University of North Carolina at Chapel Hill to include delivery specimens (placenta, cord tissue, and cord blood). This will provide an unprecedented resource-generating opportunity for the larger scientific community to comprehensively evaluate mechanisms that mediate the connection between substance use during pregnancy and adverse neonatal, infant, and/or maternal health outcomes and inform innovative preventive strategies.

1R01HD113143-01
Association of Maternal, Fetal, and Placental Biomarkers with Neonatal Neuroimaging and Development Following In-Utero Opioid Exposure Enhanced Outcomes for Infants and Children Exposed to Opioids The Biology of Opioid Exposure During Pregnancy and Effects on Early Neuro-Behavioral Development NICHD BOSTON MEDICAL CENTER WACHMAN, ELISHA Boston, MA 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-23-032
Summary:

Exposure of the developing fetus to opioids during pregnancy in women with opioid use disorder can lead to inefficient placenta function and impaired fetal brain development and neurodevelopmental outcomes. This project will measure molecules that circulate within maternal blood to identify specific indicators (biomarkers) of maternal health such as inflammation and changes in placental gene activity. The research will include a focus on specialized molecules released from the placenta called exosomes that carry information about the health of the placenta. These data will be combined with neurodevelopmental measures of infants at 1 year of age. Together, these studies will provide new molecular predictors (biomarkers) of placenta and fetal health.

3U01DA055354-03S1
HBCD Study Biospecimens Administrative Supplement: Resource Generation for Delivery Specimens 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 2023
NOFO Title: Notice of Special Interest (NOSI): HEAL Initiative: Biospecimen Collection in Pregnancy
NOFO Number: NOT-DA-23-005
Summary:

Opioid use during pregnancy is associated with adverse outcomes for pregnant individuals and offspring. The mechanisms through which these outcomes arise and the consequences of prenatal opioid exposure on child health and development remain largely unexplored. The HEALthy Brain and Child Development (HBCD) Study is a nationwide longitudinal prospective study of early child development that will assess a broad spectrum of biological, behavioral, social, and health factors among 7,500 pregnant women and their children from pregnancy to mid-childhood. This supplement will expand the biospecimen collection of the HBCD protocol at the University of North Carolina at Chapel Hill to include delivery specimens (placenta, cord tissue, and cord blood). This will provide an unprecedented resource-generating opportunity for the larger scientific community to comprehensively evaluate mechanisms that mediate the connection between substance use during pregnancy and adverse neonatal, infant, and/or maternal health outcomes and inform innovative preventive strategies. 

1R01DA059321-01
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.

3U01DA055365-03S1
HBCD Study Biospecimens Administrative Supplement: Resource Generation for Delivery Specimens Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA CHILDREN'S HOSP OF PHILADELPHIA HUANG, HAO (contact); DEMAURO, SARA BONAMO Philadelphia, PA 2023
NOFO Title: Notice of Special Interest (NOSI): HEAL Initiative: Biospecimen Collection in Pregnancy
NOFO Number: NOT-DA-23-005
Summary:

Opioid use during pregnancy is associated with adverse outcomes for pregnant individuals and offspring. The mechanisms through which these outcomes arise and the consequences of prenatal opioid exposure on child health and development remain largely unexplored. The HEALthy Brain and Child Development (HBCD) Study is a nationwide longitudinal prospective study of early child development that will assess a broad spectrum of biological, behavioral, social, and health factors among 7,500 pregnant women and their children from pregnancy to mid-childhood. This supplement will expand the biospecimen collection of the HBCD protocol at the University of North Carolina at Chapel Hill to include delivery specimens (placenta, cord tissue, and cord blood). This will provide an unprecedented resource-generating opportunity for the larger scientific community to comprehensively evaluate mechanisms that mediate the connection between substance use during pregnancy and adverse neonatal, infant, and/or maternal health outcomes and inform innovative preventive strategies.

1R01HD113199-01
The Opioid in Pregnancy: Imaging of Oxygenation, Inflammation, and Development in Brain & Placenta Project (OPIOID BPP) Enhanced Outcomes for Infants and Children Exposed to Opioids The Biology of Opioid Exposure During Pregnancy and Effects on Early Neuro-Behavioral Development NICHD WASHINGTON UNIVERSITY KELLY, JEANNIE CHEN (contact); WANG, YONG Saint Louis, MO 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-23-030
Summary:

Opioid use disorder during pregnancy is associated with poor infant outcomes including neonatal opioid withdrawal syndrome (NOWS) and impaired brain development during childhood. This project will use advanced imaging techniques to measure inflammation in the placenta and evaluate brain structure of the developing fetus. These data will be combined with measures of infant NOWS and neurodevelopmental outcomes at birth and 1 year of age. This research will explore the value of these imaging methods as diagnostic tools for infants exposed to opioids during pregnancy. The research will also study the effect of opioids on the placenta’s ability to provide oxygen to the growing fetus as well as the potential for inflammation to damage the placenta and harm development of the fetal brain. 

1R01DA059176-01
Multimodal Analysis of Gestational Health and Placental Injury in Opioid-Affected Pregnancies Enhanced Outcomes for Infants and Children Exposed to Opioids The Biology of Opioid Exposure During Pregnancy and Effects on Early Neuro-Behavioral Development NIDA MAGEE-WOMEN'S RES INST AND FOUNDATION OUYANG, YINGSHI (contact); KRANS, ELIZABETH E; SADOVSKY, YOEL Pittsburgh, PA 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-23-038
Summary:

This project will study the harmful effects of illicit and prescription opioid use during pregnancy and its consequences on the mother, fetus, and placenta. The research will integrate multiple different technologies to study molecular changes in biospecimens taken from research participants. Samples to be collected at birth and characterized include plasma and urine from the mother across the three trimesters of pregnancy, tissue samples of the placenta, and fetal cord blood. This research aims to shed new light on the underlying biology of opioid exposure on the placenta during pregnancy toward development of early interventions during opioid-exposed pregnancies. 

3U24DA055330-03S1  
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); FAIR, DAMIEN A Saint Louis, MO 2023
NOFO Title: Notice of Special Interest (NOSI): HEAL Initiative: Biospecimen Collection in Pregnancy
NOFO Number: NOT-DA-23-005
Summary:

Opioid use during pregnancy is associated with adverse outcomes for pregnant individuals and offspring. The mechanisms through which these outcomes arise and the consequences of prenatal opioid exposure on child health and development remain largely unexplored. The HEALthy Brain and Child Development (HBCD) Study is a nationwide longitudinal prospective study of early child development that will assess a broad spectrum of biological, behavioral, social, and health factors among 7,500 pregnant women and their children from pregnancy to mid-childhood. This supplement will expand the biospecimen collection of the HBCD protocol at the University of North Carolina at Chapel Hill to include delivery specimens (placenta, cord tissue, and cord blood). This will provide an unprecedented resource-generating opportunity for the larger scientific community to comprehensively evaluate mechanisms that mediate the connection between substance use during pregnancy and adverse neonatal, infant, and/or maternal health outcomes and inform innovative preventive strategies.

1R01DA059177-01
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.

3U01DA055359-03S1
HBCD Study Biospecimens Administrative Supplement: Resource Generation for Delivery Specimens 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 Albuquerque, NM 2023
NOFO Title: Notice of Special Interest (NOSI): HEAL Initiative: Biospecimen Collection in Pregnancy
NOFO Number: NOT-DA-23-005
Summary:

Opioid use during pregnancy is associated with adverse outcomes for pregnant individuals and offspring. The mechanisms through which these outcomes arise and the consequences of prenatal opioid exposure on child health and development remain largely unexplored. The HEALthy Brain and Child Development (HBCD) Study is a nationwide longitudinal prospective study of early child development that will assess a broad spectrum of biological, behavioral, social, and health factors among 7,500 pregnant women and their children from pregnancy to mid-childhood. This supplement will expand the biospecimen collection of the HBCD protocol at the University of North Carolina at Chapel Hill to include delivery specimens (placenta, cord tissue, and cord blood). This will provide an unprecedented resource-generating opportunity for the larger scientific community to comprehensively evaluate mechanisms that mediate the connection between substance use during pregnancy and adverse neonatal, infant, and/or maternal health outcomes and inform innovative preventive strategies

1R01DA059181-01
Fentanyl Use During Pregnancy: Impact on Dam, Placenta, and Offspring Development 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 MISSISSIPPI MED CTR RÜEDI-BETTSCHEN, DANIELA Jackson, MS 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-23-036
Summary:

The number of women misusing opioids during pregnancy has more than quadrupled in recent years, with fentanyl use rising to an all-time high. The exposure puts the fetus at serious risk for opioid withdrawal, as well as developmental and behavioral effects during infancy and childhood. This project will study the effects of fentanyl use during pregnancy on maternal physiology and stress, function of the placenta, pregnancy outcomes, as well as infant withdrawal symptoms, development, and stress. This research aims to identify new strategies for diagnosing, treating, and preventing opioid harm to the fetus and mother.

3U01DA055367-03S1
23/24 HEALthy Brain and Child Development National Consortium Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA WASHINGTON UNIVERSITY ROGERS, CYNTHIA ELISE (contact); BOGDAN, RYAN H Saint Louis, MO 2023
NOFO Title: Notice of Special Interest (NOSI): HEAL Initiative: Biospecimen Collection in Pregnancy
NOFO Number: NOT-DA-23-005
Summary:

Opioid use during pregnancy is associated with adverse outcomes for pregnant individuals and offspring. The mechanisms through which these outcomes arise and the consequences of prenatal opioid exposure on child health and development remain largely unexplored. The HEALthy Brain and Child Development (HBCD) Study is a nationwide longitudinal prospective study of early child development that will assess a broad spectrum of biological, behavioral, social, and health factors among 7,500 pregnant women and their children from pregnancy to mid-childhood. This supplement will expand the biospecimen collection of the HBCD protocol at the University of North Carolina at Chapel Hill to include delivery specimens (placenta, cord tissue, and cord blood). This will provide an unprecedented resource-generating opportunity for the larger scientific community to comprehensively evaluate mechanisms that mediate the connection between substance use during pregnancy and adverse neonatal, infant, and/or maternal health outcomes and inform innovative preventive strategies.

1R01HD113188-01
Impact of Maternal Substance Use on Offspring Neurobehavioral Development Enhanced Outcomes for Infants and Children Exposed to Opioids The Biology of Opioid Exposure During Pregnancy and Effects on Early Neuro-Behavioral Development NICHD MASSACHUSETTS GENERAL HOSPITAL EDLOW, ANDREA GOLDBERG (contact); BOGDAN, RYAN H; LO, JAMIE ; SULLIVAN, ELINOR L Boston, MA 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-23-031
Summary:

Opioid use disorder with simultaneous misuse of cannabis and alcohol during pregnancy is associated with increased risk for several infant neurodevelopmental problems. This project will evaluate the effects of opioids and other substances of misuse on the mother’s immune system by studying maternal immune cells and measuring molecules in her blood. The research will also study the role of the nerve communication molecule serotonin produced by the placenta. This research will take advantage of data from the HEALthy Brain and Child Development Study that is focused on child development measures. Together, these studies will provide important new insights into the ways misused substances affect infant brain development and neurodevelopmental outcomes.

3U01DA055352-03S1
1/6 HBCD Prenatal Experiences and Longitudinal Development (PRELUDE) Consortium Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA ARKANSAS CHILDREN'S HOSPITAL RES INST OU, XIAWEI (contact); ACHESON, ASHLEY; MCKELVEY, LORRAINE M Little Rock, AR 2023
NOFO Title: Notice of Special Interest (NOSI): HEAL Initiative: Biospecimen Collection in Pregnancy
NOFO Number: NOT-DA-23-005
Summary:

Opioid use during pregnancy is associated with adverse outcomes for pregnant individuals and offspring. The mechanisms through which these outcomes arise and the consequences of prenatal opioid exposure on child health and development remain largely unexplored. The HEALthy Brain and Child Development (HBCD) Study is a nationwide longitudinal prospective study of early child development that will assess a broad spectrum of biological, behavioral, social, and health factors among 7,500 pregnant women and their children from pregnancy to mid-childhood. This supplement will expand the biospecimen collection of the HBCD protocol at the University of North Carolina at Chapel Hill to include delivery specimens (placenta, cord tissue, and cord blood). This will provide an unprecedented resource-generating opportunity for the larger scientific community to comprehensively evaluate mechanisms that mediate the connection between substance use during pregnancy and adverse neonatal, infant, and/or maternal health outcomes and inform innovative preventive strategies.

1R01DA059152-01
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.   

3U01DA055363-03S1 
12/24 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 OREGON HEALTH & SCIENCE UNIVERSITY SULLIVAN, ELINOR L (contact); GRAHAM, ALICE M; NAGEL, BONNIE J Portland, OR 2023
NOFO Title: Notice of Special Interest (NOSI): HEAL Initiative: Biospecimen Collection in Pregnancy
NOFO Number: NOT-DA-23-005
Summary:

Opioid use during pregnancy is associated with adverse outcomes for pregnant individuals and offspring. The mechanisms through which these outcomes arise and the consequences of prenatal opioid exposure on child health and development remain largely unexplored. The HEALthy Brain and Child Development (HBCD) Study is a nationwide longitudinal prospective study of early child development that will assess a broad spectrum of biological, behavioral, social, and health factors among 7,500 pregnant women and their children from pregnancy to mid-childhood. This supplement will expand the biospecimen collection of the HBCD protocol at the University of North Carolina at Chapel Hill to include delivery specimens (placenta, cord tissue, and cord blood). This will provide an unprecedented resource-generating opportunity for the larger scientific community to comprehensively evaluate mechanisms that mediate the connection between substance use during pregnancy and adverse neonatal, infant, and/or maternal health outcomes and inform innovative preventive strategies.

3PL1HD101059-01S3
Administrative Supplement for ACT NOW OBOE Longitudinal Study Enhanced Outcomes for Infants and Children Exposed to Opioids Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) NICHD RESEARCH TRIANGLE INSTITUTE (NC) BANN, CARLA M Research Triangle Park, NC 2021
NOFO Title:
NOFO Number: PA-20-272
3PL1HD101059-01S2
Administrative Supplement to Increase Participant Diversity, Inclusion and Engagement in the ACT NOW OBOE Study Enhanced Outcomes for Infants and Children Exposed to Opioids Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) NICHD RESEARCH TRIANGLE INSTITUTE BANN, CARLA M Research Triangle Park, NC 2021
NOFO Title: HEAL Initiative: Notice of Special Interest (NOSI) regarding the Availability of Administrative Supplements to Support Strategies to Increase Participant Diversity, Inclusion and Engagement in Clinical Studies
NOFO Number: NOT-NS-21-025
Summary:

The ACT NOW Outcomes of Babies with Opioid Exposure (OBOE) Study – also called the ACT NOW Longitudinal Study – is a longitudinal cohort study to prospectively examine longitudinal outcomes from birth to 2 years of age among infants who were exposed to opioids in utero as compared to matched controls. The objectives of this study are to i) determine the impact of pre-birth opioid exposure on brain structure and connectivity over the first 2 years of life, ii) define medical, developmental, and behavioral outcomes over the first 2 years of life in infants exposed to opioids, and iii) Explore whether and how the home environment, maternal mental health, and parenting affect brain connectivity and neurodevelopment trajectories over the first 2 years of life. This research will use an innovative approach to engage a more diverse study population and thereby improve the generalizability of the research findings.

1UG1HD107653-01
Incorporating nonpharmacologic approaches into a comparative effectiveness pharmacologic trial for neonates with neonatal opioid withdrawal syndrome (NOWS) Enhanced Outcomes for Infants and Children Exposed to Opioids Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) NICHD INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS (IN) SOKOL, GREGORY M Indianapolis, IN 2021
NOFO Title: HEAL Initiative: Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial - Clinical Sites (UG1 Clinical Trial Required)
NOFO Number: RFA-HD-21-031
Summary:

Neonatal Opioid Withdrawal Syndrome (NOWS) is a condition that occurs when newborns are exposed to opioids during pregnancy. Symptoms often include tremors, excessive crying, sleep deprivation, and swallowing difficulties. Cases are rising, with a newborn affected by NOWS approximately every 15 minutes. Currently, healthcare providers in the United States lack standard, evidence-based treatments for NOWS.

1U01DA055349-01
10/24 Healthy Brain and Child Development National Consortium Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA OSU CENTER FOR HEALTH SCIENCES CROFF, JULIE MAY (contact); HAYS-GRUDO, JENNIFER ; MORRIS, AMANDA S Tulsa, OK 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. This study will take place at Oklahoma State University Center for Health Sciences and recruit diverse people from an urban area, including American Indian populations.

1UG1HD107628-01
Thomas Jefferson University Hospital Clinical Site for HEAL NOWS Pharmacologic Trial Enhanced Outcomes for Infants and Children Exposed to Opioids Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) NICHD THOMAS JEFFERSON UNIVERSITY  (PA) KRAFT, WALTER K (contact); ADENIYI-JONES, SUSAN Philadelphia, PA 2021
NOFO Title: HEAL Initiative: Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial - Clinical Sites (UG1 Clinical Trial Required)
NOFO Number: RFA-HD-21-031
Summary:

Neonatal Opioid Withdrawal Syndrome (NOWS) is a condition that occurs when newborns are exposed to opioids during pregnancy. Symptoms often include tremors, excessive crying, sleep deprivation, and swallowing difficulties. Cases are rising, with a newborn affected by NOWS approximately every 15 minutes. Currently, healthcare providers in the United States lack standard, evidence-based treatments for NOWS. 

This project is part of a multi-center, randomized controlled clinical trial that directly compares NOWS treatments—morphine, methadone, and buprenorphine—and takes into account other types of non-drug therapies, such as behavioral interventions. The goal is to generate results that can inform clinical practice guidelines and give newborns with NOWS the best start possible. 

Thomas Jefferson University has more than 40 years of experience optimizing approaches to the care of opioid use disorder in pregnancy and conducts clinical research on NOWS treatments. The hospital provides a robust continuum of care that supports women with opioid use disorders before, during, and after delivery. This supportive culture has resulted in a relatively high rate of clinical trial participation that will enable long-term follow up of mothers and infants.