WIP 19 - Serum biomarkers of brain injury in infants with prenatal opioid exposure

Publication Number: WIP 19.7482

Austin R. Sellers, Johns Hopkins All Children's Hospital, St Petersburg, FL, United States; Nethra Madurai, Johns Hopkins Children's Center, Baltimore, MD, United States; Raul Chavez-Valdez, Johns Hopkins University School of Medicine, Baltimore, MD, United States; Dhananjay Vaidya, Johns Hopkins University, Baltimore, MD, United States; Lauren Jantzie, Johns Hopkins University School of Medicine, Baltimore, MD, United States; Jordan Richard. Kuiper, George Washington University Milken Institute School of Public Health, Washington, DC, United States; Prasad H. Babar, Johns Hopkins University School of Medicine, Crofton, MD, United States; Iris N. Ambuehl, Johns Hopkins University, Baltimore, MD, United States; Charlamaine Parkinson, Johns Hopkins Children's Center, Baltimore, MD, United States; Frances Northington, Johns Hopkins University School of Medicine, Baltimore, MD, United States; Allen Everett, Johns Hopkins University School of Medicine, Baltimore, MD, United States; Sandra Brooks, Johns Hopkins All Children's Hospital, St Petersburg, FL, United States

Background: There are a rising number of infants exposed to opioids prenatally leading to increased healthcare costs associated with hospitalization and care. Beyond initial withdrawal symptoms characterized as neonatal opioid withdrawal syndrome, growing concerns exist for long-term neurodevelopmental consequences associated with prenatal opioid exposure (POE). Early markers suggesting the mechanisms underlying long-term neural injury associated with POE are crucial to impact long-term health outcomes.

Objective: The primary objective of this study is to compare biomarker levels in neonates with POE to neonates without POE. We hypothesize that biomarkers associated with neural development [glial fibrillary acidic protein and neurogranin], and inflammatory interleukins (IL-6, -8, and -10) will be elevated in neonates with POE compared to controls on admission. Secondary aims will assess biomarker concentrations longitudinally over the first week of life, and compare infants with POE requiring pharmacologic intervention to those not requiring additional opioids.

Design/Methods: This is an ancillary study from a prospective study, both of which received IRB approval. Enrolled infants were admitted to two quaternary NICU's from 2016-2020. Infants included for analysis had a positive urine drug screen upon admission to the NICU, the cohort includes all gestational ages and comparison group is randomly selected after being age-matched. Infants with concomitant neurologic diagnoses or genetic anomalies were excluded. In addition to demographic and outcome data, serum biomarker data will be analyzed longitudinally on DOL 0-7. Regression modeling will include longitudinal biomarkers as independent variables. We will use a multinomial logistic regression model to jointly evaluate POE diagnosis with/without need for treatment as outcomes. To date, all data has been collected and data analysis is ongoing. Project will be finalized with all analyses completed by January 1, 2025.