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Outcomes of Babies with Opioid Exposure (OBOE): protocol of a prospective longitudinal cohort study
Carla M Bann1, Jamie E Newman2, Brenda Poindexter3
1RTI International, Research Triangle Park, NC, USA. cmb@rti.org.
Insights
Maternal opioid use impacts fetal brain development. The Outcomes of Babies with Opioid Exposure (OBOE) study tracks neurodevelopmental outcomes in infants exposed to opioids antenatally, identifying early biomarkers.
Area of Science:
- Neuroscience
- Developmental Biology
- Pediatrics
Background:
- The health and socioeconomic impacts of adult opioid addiction are recognized.
- The effects of maternal opioid use on fetal development are less understood.
- Prenatal opioid exposure poses risks to infant brain development.
Purpose of the Study:
- To determine the impact of antenatal opioid exposure on infant brain development and neurodevelopmental outcomes up to 2 years of age.
- To investigate how family, home, and community factors influence developmental trajectories in infants with prenatal opioid exposure.
- To establish the Outcomes of Babies with Opioid Exposure (OBOE) Study protocol for a multi-site prospective longitudinal cohort study.
Main Methods:
- Prospective longitudinal cohort study design comparing infants with antenatal opioid exposure to unexposed controls.
- Serial MRI assessments from birth to 2 years to examine brain development trajectories.
- Comprehensive neurodevelopmental assessments including cognitive, language, motor, and social-emotional skills.
- Umbilical cord assays to accurately quantify prenatal opioid and substance exposure.
Main Results:
- Primary outcomes include analysis of cortical volumes, deep gray matter volumes, and functional/structural brain connectivity using diffusion tensor imaging.
- Neurodevelopmental outcomes assessed via the Bayley Scales of Infant Development and the Brief Infant-Toddler Social and Emotional Assessment.
- Integration of MRI findings and neurodevelopmental assessments to identify early functional brain topography and potential biomarkers.
Conclusions:
- The OBOE study protocol is designed to address limitations of previous research on prenatal opioid exposure.
- This study will provide crucial insights into the effects of antenatal opioid exposure on early infant brain development.
- Findings will enhance understanding of neurodevelopmental trajectories and identify potential biomarkers for early intervention.
Background:
While the health, social, and economic impacts of opioid addiction on adults and their communities are well known, the impact of maternal opioid use on the fetus exposed in utero is less well understood.
Methods:
This paper presents the protocol of the ACT NOW Outcomes of Babies with Opioid Exposure (OBOE) Study, a multi-site prospective longitudinal cohort study of infants with antenatal opioid exposure and unexposed controls. Study objectives are to determine the impact of antenatal opioid exposure on brain development and neurodevelopmental outcomes over the first 2 years of life and explore whether family, home, and community factors modify developmental trajectories during this critical time period.
Results:
Primary outcomes related to brain development include cortical volumes, deep cerebral gray matter volumes, resting-state functional connectivity measures, and structural connectivity measures using diffusion tensor imaging. Primary neurodevelopmental outcomes include visual abnormalities, cognitive, language, and motor skills measured using the Bayley Scales of Infant Development and social-emotional and behavioral problems and competence measured by the Brief Infant-Toddler Social and Emotional Assessment.
Conclusions:
The OBOE study has been designed to overcome challenges of previous studies and will help further understanding of the effects of antenatal opioid exposure on early infant development.
Impact:
This study will integrate MRI findings and comprehensive neurodevelopmental assessments to provide early insights into the functional topography of the brain in this high-risk population and assess MRI as a potential biomarker. Rather than conducting neuroimaging at a single time point, the study will include serial MRI assessments from birth to 2 years, allowing for the examination of trajectories throughout this period of rapid brain development. While previous studies often have had limited information on exposures, this study will use umbilical cord assays to accurately measure amounts of opioids and other substances from 20 weeks of gestation to birth.
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