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Project #	Project Title	Research Focus Area	Research Program	Administering IC	Institution(s)	Investigator(s)	Location(s)	Year Awarded Sort ascending
1U01DA055347-01 Show Summary	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.
1UG1HD107580-01 Show Summary	UAB Clinical Site HEAL Neonatal Opioid Withdrawal Pharmacological Treatments	Enhanced Outcomes for Infants and Children Exposed to Opioids	Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW)	NICHD	UNIVERSITY OF ALABAMA AT BIRMINGHAM (AL)	AMBALAVANAN, NAMASIVAYAM	Birmingham, AL	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. The University of Alabama at Birmingham routinely treats newborns with NOWS and has been part of NICHD’s Neonatal Research Network (NRN) for more than 25 years. The center has an excellent track record of enrollment in clinical studies, with successful follow-up to 2 years of age and beyond.
1U01DA055358-01 Show Summary	15/24 Healthy Brain and Child Development National Consortium	Enhanced Outcomes for Infants and Children Exposed to Opioids	HEALthy Brain and Child Development Study (HBCD)	NIDA	UNIVERSITY OF FLORIDA	GURKA, MATTHEW JAMES (contact); GURKA, KELLY K; SCOTT, LISA S	Gainesville, FL	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 Florida study site will recruit a diverse group of mother-infant pairs from urban and rural communities in North Central Florida.
1UG1HD107650-01 Show Summary	HEAL Initiative: Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial Clinical Site	Enhanced Outcomes for Infants and Children Exposed to Opioids	Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW)	NICHD	UNIV OF ARKANSAS FOR MED SCIS (AR)	HALL, RICHARD WHITTINGTON	Little Rock, AR	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. Arkansas is a rural state with the second highest opioid prescription rate in the nation and is in the top 3 states nationwide for opioid prescriptions to pregnant mothers. This site has extensive experience in opioid research and conducting multi-center clinical trials. It also provides care to a diverse population.
1U01DA055365-01 Show Summary	3/24 Healthy Brain and Child Development National Consortium	Enhanced Outcomes for Infants and Children Exposed to Opioids	HEALthy Brain and Child Development Study (HBCD)	NIDA	CHILDREN'S HOSP OF PHILADELPHIA	HUANG, HAO (contact); DEMAURO, SARA BONAMO	Philadelphia, 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. This study will be based out of the Children’s Hospital of Philadelphia and the University of Pennsylvania and will represent an urban population with a wide socioeconomic status range.
1UG1HD107628-01 Show Summary	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.
1U01DA055360-01 Show Summary	4/24 Healthy Brain and Child Development National Consortium	Enhanced Outcomes for Infants and Children Exposed to Opioids	HEALthy Brain and Child Development Study (HBCD)	NIDA	EMORY UNIVERSITY	KABLE, JULIE A (contact); COLES, CLAIRE D	Atlanta, GA	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 be conducted at Emory University School of Medicine in Atlanta, Georgia, allowing access to a diverse population with a high representation of Black/African American women.
1UG1HD107627-01 Show Summary	HEAL Initiative: Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial New Mexico Site	Enhanced Outcomes for Infants and Children Exposed to Opioids	Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW)	NICHD	UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR (NM)	LEEMAN, LAWRENCE M	Albuquerque, NM	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. New Mexico is an epicenter of the opioid epidemic with high rates of maternal opioid use disorder and NOWS. This site has expertise in multi-center clinical trials for newborns, a history of high rates of study recruitment and follow-up, and a diverse population that includes Latinx and Native American women. The hospital currently cares for infants with NOWS in a variety of settings, including rooming in, a nursery, and a neonatal intensive care unit.
1U01DA055342-01 Show Summary	4/6 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	CINCINNATI CHILDRENS HOSP MED CTR	MERHAR, STEPHANIE L (contact); VANNEST, JENNIFER J	Cincinnati, OH	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 HEALthy Brain and Child Development (HBCD) Prenatal Experiences and Longitudinal Development (PRELUDE) 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 Cincinnati Children’s Hospital study site is in a region hit hard by the opioid crisis and has a large catchment area that includes many rural counties in Ohio, Kentucky, Indiana, and West Virginia.
1U01DA055350-01 Show Summary	7/24 Healthy Brain and Child Development National Consortium	Enhanced Outcomes for Infants and Children Exposed to Opioids	HEALthy Brain and Child Development Study (HBCD)	NIDA	JOHNS HOPKINS UNIVERSITY	VOLK, HEATHER E (contact); PEKAR, JAMES J; SATIN, ANDREW J	Baltimore, 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. This study will be conducted at Johns Hopkins University in Baltimore, Maryland, and researchers will recruit diverse participants from a range of backgrounds.
1UG1HD107631-01 Show Summary	Neonatal Treatment Trial	Enhanced Outcomes for Infants and Children Exposed to Opioids	Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW)	NICHD	CHILDREN'S HOSP OF PHILADELPHIA (PA)	LORCH, SCOTT A	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. This site includes newborn nurseries and intensive care nurseries at 4 large maternity centers across the Children’s Hospital of Philadelphia (CHOP) Newborn Care Network, each with a dedicated follow-up clinic, ensuring access to a large and diverse patient population for long-term study. CHOP also has a long history of successfully conducting multi-center clinical studies.
1U01DA055362-01 Show Summary	2/24 Healthy Brain and Child Development National Consortium	Enhanced Outcomes for Infants and Children Exposed to Opioids	HEALthy Brain and Child Development Study (HBCD)	NIDA	CHILDREN'S HOSPITAL OF LOS ANGELES	LEVITT, PAT (contact); SMITH, BETH A; WISNOWSKI, JESSICA L	Los Angeles, CA	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 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. 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 Children’s Hospital of Los Angeles study site will enroll participants from across the Greater Los Angeles region, where the prevalence of legal and illegal non-opioid drug use is high, enabling researchers to recruit from diverse, high-risk populations.
1U01DA055367-01 Show Summary	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	St Louis, MO	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 Washington University in St. Louis, Missouri, and will recruit participants from an urban environment with a high African American population.
1UG1HD107616-01 Show Summary	HEAL Initiative: Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial: Cincinnati Site	Enhanced Outcomes for Infants and Children Exposed to Opioids	Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW)	NICHD	CINCINNATI CHILDRENS HOSP MED CTR (OH)	MERHAR, STEPHANIE L	Cincinnati, OH	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. Ohio and Kentucky have high rates of opioid-related overdose deaths in the nation. This site is a large regional perinatal center, providing clinical services for approximately 25,000 newborns each year. It also actively participates in other HEAL Initiative studies.
1U01DA055359-01 Show Summary	18/24 Healthy Brain and Child Development National Consortium	Enhanced Outcomes for Infants and Children Exposed to Opioids	HEALthy Brain and Child Development Study (HBCD)	NIDA	UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR	BAKHIREVA, LUDMILA NICOLE (contact); LEEMAN, LAWRENCE M	Albuquerque, NM	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. 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 New Mexico Health Science Center study site is in a largely rural/mixed state with one of the highest rates of overdose in the nation. This site will enroll diverse mother-infant pairs and partners or caregivers, including Hispanic/Latinx and American Indian individuals.
1U01DA055338-01 Show Summary	8/24 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	NEW YORK UNIVERSITY SCHOOL OF MEDICINE	THOMASON, MORIAH E (contact); BERRY, OBIANUJU ; SHUFFREY, LAUREN CHRISTINE	New York, NY	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 decade of life. This study will take place at New York University School of Medicine, allowing researchers to recruit participants from two of the largest private and public health systems in the country and include racial and ethnic minorities of varying economic levels.
1UG1HD107649-01 Show Summary	Neonatal Opioid Withdrawal Syndrome (NOWS) in Kentucky: Improving Outcomes for Infants	Enhanced Outcomes for Infants and Children Exposed to Opioids	Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW)	NICHD	UNIVERSITY OF LOUISVILLE (KY)	DEVLIN-PHINNEY, LORI ANN (contact); TELANG, SUCHETA	Louisville, KY	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. The University of Louisville serves a large, diverse population that is disproportionately affected by the opioid crisis. Mothers and infants treated by the university’s healthcare team live in rural and urban underserved regions where the frequency of opioid use during pregnancy is among the highest in the country, with a rate estimated at 3 times the national average.
1U01DA055366-01 Show Summary	1/24 Healthy Brain and Child Development National Consortium	Enhanced Outcomes for Infants and Children Exposed to Opioids	HEALthy Brain and Child Development Study (HBCD)	NIDA	CEDARS-SINAI MEDICAL CENTER	GAO, WEI (contact); GREGORY, KIMBERLY D; JOHNSON, SCOTT P; SMITH, LYNNE M	Los Angeles, CA	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 Cedars-Sinai Medical Center study site is in Los Angeles where marijuana is legal and methamphetamine use is prevalent, enabling researchers to recruit participants from high-risk populations.
1U01DA055322-01 Show Summary	HEALthy Brain and Child Development Study at UAB and UA	Enhanced Outcomes for Infants and Children Exposed to Opioids	HEALthy Brain and Child Development Study (HBCD)	NIDA	UNIVERSITY OF ALABAMA AT BIRMINGHAM	PERALTA-CARCELEN, ADA MYRIAM (contact); NEWMAN, SHARLENE D; NEWSOM, CASSANDRA R; YERBY, LEA GEORGETTE	Birmingham, AL	2021
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (U01- Clinical Trial Not Allowed) NOFO Number: RFA-DA-21-021 Summary: Researchers at the University of Alabama at Birmingham and the University of Alabama will enroll pregnant women during their second trimester and follow their infants through a comprehensive longitudinal study. This program will follow 300 mother-infant pairs to understand how early life exposure to drugs and other environmental factors affects developmental trajectories. In addition, this program will determine how genetic and biological factors interact with environmental factors to influence neurodevelopment. This study will take place at the University of Alabama at Birmingham, recruiting participants from mainly rural populations with low access to obstetric/gynecological (OB/GYN) care and high rates of substance use.
1UG1HD107653-01 Show Summary	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.
1U01DA055352-01 Show Summary	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	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 HEALthy Brain and Child Development (HBCD) Prenatal Experiences and Longitudinal Development (PRELUDE) 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 Arkansas Children’s Research Institute site is in a predominantly rural state with the second highest rate of opioid prescriptions in the U.S.
1U01DA055343-01 Show Summary	1/2 Assessing the Cumulative Impact of Early Life Substance and Environment Exposure on Child Neurodevelopment and Health	Enhanced Outcomes for Infants and Children Exposed to Opioids	HEALthy Brain and Child Development Study (HBCD)	NIDA	RHODE ISLAND HOSPITAL	DEONI, SEAN CL (contact); D'SA, VIREN ANDREW	Providence, RI	2021
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed) NOFO Number: RFA-DA-21-020 Summary: This study aims to determine how exposure to opioids and other substances affects the developing fetal brain and shapes later child cognitive outcomes. Researchers will collect neuroimaging and behavioral data, as well as measures of environmental exposures related to social equity, COVID-19, and socioeconomic factors. The project will reduce traditional barriers to participation by using innovative data collection methods and mobile labs to bring the research to underrepresented and marginalized communities. This approach aims to clarify the impact of substance exposure on child development through an equitable approach to research, with generalizable findings. The study will take place at Rhode Island Hospital, where participants will be drawn from a largely rural population.
3PL1HD101059-01S2 Show Summary	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.
1U01DA055353-01 Show Summary	5/24 Healthy Brain and Child Development National Consortium	Enhanced Outcomes for Infants and Children Exposed to Opioids	HEALthy Brain and Child Development Study (HBCD)	NIDA	BOSTON CHILDREN'S HOSPITAL	GRANT, PATRICIA ELLEN (contact); BOSQUET ENLOW, MICHELLE A	Boston, MA	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 Boston Children’s Hospital study site is in Massachusetts, which has the fifth highest rate of opioid use in the U.S., and twice the U.S. average incidence of opioid use disorder in delivering mothers.
1U01DA055370-01 Show Summary	21/24 Healthy Brain and Child Development National Consortium	Enhanced Outcomes for Infants and Children Exposed to Opioids	HEALthy Brain and Child Development Study (HBCD)	NIDA	UNIVERSITY OF WISCONSIN-MADISON	DEAN III, DOUGLAS CARL (contact); POEHLMANN-TYNAN, JULIE A	Madison, WI	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 the University of Wisconsin, Madison, where researchers will have access to a diverse group of people, including women with criminal justice involvement.