UAB Outcomes of Babies with Opioid Exposure (OBOE study)

Project Summary
Limited data are available on the effects of prenatal opioid exposure on the brain and
neurodevelopment. The Outcomes of Babies with Opioid Exposure (OBOE) study, an ongoing NICHD-funded
longitudinal study enrolling infants with and without prenatal opioid exposure at birth and following them to 2
years of age, is collecting comprehensive exposure data including infant umbilical cords, advanced
neuroimaging data to evaluate brain development, and standardized and thorough information on the home
environment, maternal mental health, and parenting. The OBOE consortium has completed our goal enrollment
of 200 opioid-exposed infants and 100 unexposed infants with complete data at 0-1 months of age. In response
to RFA-HD-24-014, we now propose to complete follow-up to age 2, to fulfill our main study objectives. The
UAB site has contributed to the OBOE study by enrolling 52 opioid-exposed and 26 control infants, completing
92 MRIs so far, and contributing to the publication of multiple abstracts and three manuscripts using OBOE
data. The Specific Aims for this renewal grant are to:
Specific Aim 1: To determine the impact of prenatal opioid exposure on brain structure and
connectivity over the first two years of life. We have made progress toward this aim and have submitted
2 abstracts showing that prenatal opioid exposure is associated with increased white matter injury,
reductions in global, regional, and tissue-specific brain volumes, and altered functional connectivity.
Specific Aim 2: To define medical, developmental, and behavioral trajectories over the first 2 years
of life in infants exposed to opioids. As we recently completed enrollment, this aim is ongoing. We have
analyzed umbilical cord data showing that infants with prenatal opioid exposure are often exposed to other
psychotropic drugs, and are analyzing the effects of polysubstance exposure on newborn behavior.
Specific Aim 3: To determine how the home environment, maternal mental health, and parenting
modify trajectories of brain connectivity and neurodevelopment over the first two years of life. This
aim is also ongoing. We have published our data from maternal questionnaires showing that mothers with
opioid use during pregnancy experience more stigma in the healthcare environment, and that mothers in
our cohort with more depression and anxiety symptoms have poor quality attachment with their infants.
Our progress so far in OBOE, with completion of enrollment and success at following this difficult
population, demonstrates ability to complete this study. Our centers have an excellent track record of enrollment
of high-risk infants in clinical studies with successful participant retention and follow-up to 2 years of age, with
trained certified examiners for neurodevelopment and established infrastructure for unsedated neonatal and
infant cranial MRI. We therefore anticipate successful completion of follow-up of the enrolled infants.

Grant Number: 5UG1HD104251-03
NIH Institute/Center: NIH
Principal Investigator: Namasivayam Ambalavanan