HEAL Initiative: Antenatal Opioid Exposure Longitudinal Study Consortium

PROJECT SUMMARY/ABSTRACT
While the health, social, and economic impacts of opioid addiction on adults are well known, the impact of
maternal opioid use on the fetus exposed in utero is less well understood. The Outcomes of Babies with
Opioid Exposure (OBOE) Study is an ongoing longitudinal cohort study to prospectively examine the
medical, neurodevelopmental, and behavioral outcomes of children who were exposed to opioids in utero as
compared with unexposed controls. The objectives of the OBOE Study are to, over the first 2 years of life, (1)
determine the impact of antenatal opioid exposure on brain structure and connectivity; (2) define medical,
developmental, and behavioral outcomes in infants exposed to opioids; and (3) explore whether and how
the home environment, maternal mental health, and parenting modify trajectories of brain connectivity
and neurodevelopment. In response to RFA-HD-24-015, RTI will continue to achieve the following specific
aims as the data coordinating center (DCC) for this renewal grant: (1) collaborate with study investigators in
developing OBOE protocols and budgets; (2) support OBOE protocol design, training, and implementation;
(3) provide data management for the consortium, including programming data management systems and
preparing reports for the SSMB, SC, OBOE subcommittees, clinical centers, and NICHD/NIH; (4) provide the
neuroimaging expertise for the consortium to help ensure standardization of neuroimaging data acquisition,
monitor image acquisition, promote sharing among sites, review and assess images, and provide subject
matter expertise for study result analyses; (5) conduct statistical analyses of study data for interim
monitoring, final results, and secondary data analyses, and collaborate with study investigators to publish
results of OBOE studies in a timely and accurate manner; (6) manage capitation funds, disbursing payments
to clinical centers based on enrolled patients and other study milestone triggers, specified in the study
protocols and budgets; and (7) provide the logistical support necessary to run an effective and productive
consortium. The DCC and four OBOE Clinical Centers have a long history of successful collaboration on
completed and ongoing neonatal follow-up studies, including MRI studies and those focused on neonatal
opioid withdrawal syndrome. RTI’s approach as the DCC has many innovations such as (1) using an RTI-
developed avatar-based Consenter video app to assist with the informed consent process; (2) combining
RTI’s extensive data science and statistical expertise with the cutting-edge neuroimaging innovations of
Children’s National Medical Center, we will complete one of the first studies on brain structure and
connectivity in opioid-exposed infants; (3) integrating analysis of both MRI findings and comprehensive
neurodevelopmental assessments; (4) analyzing serial MRI assessments to examine longitudinal trajectories
through age 2, and (5) advancing emerging research on social determinants of health and their role in child
development.

Grant Number: 5U24HD101059-03
NIH Institute/Center: NIH
Principal Investigator: CARLA BANN