The epidemic of opioid dependency in the United States and the subsequent increase in the number of infants born with neonatal opioid withdrawal syndrome (NOWS) has the potential to substantially affect not only current generations but also future ones. The Outcomes of Babies with Opioid Exposure (OBOE) Study will examine the multidimensional impact of antenatal opioid exposure and potential intervening variables, including family and environmental factors. An independent Data Coordinating Center (DCC) well experienced in neonatal follow-up studies and analyses of MRI data is essential for the multicenter OBOE Study to ensure adoption of best practices and quality control for maximal cohort retention through intensive tracking and harmonized data quality monitoring and analyses processes. Building on RTI International's successful leadership of more than 40 DCCs and ongoing collaborations with the four proposed OBOE Study Clinical Sites for many years as part of the Neonatal Research Network (NRN), the Research Support Core (RSC) will maximize the productivity of this Consortium by realizing the following specific aims: (1) advance the scientific and clinical impact of the Consortium by providing scientific and organizational leadership for the study design and implementation; (2) expedite study launch and ensure high quality and consistency of study data through effective training on protocol implementation, implementation of effective tracking tools, and execution of rigorous electronic data capture systems; (3) facilitate cohort enrollment and retention through real-time monitoring and reporting; and (4) accelerate dissemination of study findings by providing timely data analyses and data sharing and implementing data visualization techniques to effectively communicate results through presentations and publications. Dr. Carla Bann, the proposed DCC PD/PI and RSC leader, has extensive experience in providing statistical leadership for neonatal studies, including a multisite longitudinal study of the impact of antenatal cocaine and/or opioid exposure on longer- term outcomes. She will be assisted by Alternate PI and Senior Advisor, Dr. Abhik Das, PI for the NRN DCC, and Administrative Core leader, Dr. Jamie Newman, NRN Follow-Up Coordinator. application has unique strengths to help advance the Consortium research agenda: (1) a highly experienced and motivated PI and staff with years of experience and in-depth knowledge of neonatal follow-up and studies assessing antenatal drug exposure and child development; (2) a track record of scientific productivity in neonatal research; (3) a state-of-the-art infrastructure of tools, processes, and patient tracking systems that is flexible and customized to the needs of neonatal studies; (4) robust data capture and management systems to ensure data quality, and (5) an administrative structure with staffing flexibility to optimally deploy personnel and respond quickly to changing study needs.
The increasing number of infants born with neonatal opioid withdrawal syndrome due to the opioid crisis in the United States raises concerns about the longer-term impact for children with antenatal opioid exposure. The Outcomes of Babies with Opioid Exposure (OBOE) Study will examine longitudinal developmental outcomes of infants with NOWS and matched controls from birth to 2 years of age. As the Research Support Core for the Data Coordinating Center, RTI International will provide essential expertise to the multicenter OBOE Study by ensuring rigorous and consistent standards for study design, implementation, data collection, quality assurance, monitoring, and statistical analysis.
