To meet the challenge of collecting high-quality, comprehensive data examining the developmental profile, trajectory, and outcomes of infants with neonatal opioid withdrawal syndrome (NOWS), the HEAL Initiative: Antenatal Opioid Exposure Longitudinal Study Consortium requires an experienced Administrative Core that will lead and coordinate the Clinical Sites, Steering Committee, Scientific and Safety Monitoring Committee, and other Consortium members to conduct the Outcomes of Babies with Opioid Exposure (OBOE) Study. The complexity of studying a cohort of newborns exposed to opioids requires rigorous and innovative communicative, organizational, and logistical methodologies to facilitate comprehensive and valid data collection and participant retention. A knowledgeable Administrative Core will allow for the nuanced systemic needs of a study of this magnitude to be efficiently addressed and met. Building on a long, well-established history of leadership in complex DCC efforts, the Administrative Core at RTI International will maximize the productivity of the Consortium and effectively coordinate the interaction among its components by achieving the following specific aims: (1) enhance multisite study coordination and collaboration by providing the Consortium with the necessary logistical, communications, and operational support and (2) manage Clinical Site capitation by implementing an efficient and accurate payment system. Dr. Jamie Newman, the proposed Administrative Core PD/PI, has extensive DCC experience and expertise in follow-up studies of high-risk infants. Dr. Newman's history of collaboration with the proposed PD/PI Dr. Carla Bann and Alternate PD/PI Dr. Abhik Das and with the proposed Clinical Site PD/PIs and research staff will benefit the Consortium and help it more efficiently achieve its goal to develop appropriate care practices and treatments for infants exposed prenatally to opioids. Informed by our ongoing and past DCC accomplishments, we will facilitate the success of the Consortium by establishing an Administrative Core and associated organizational framework that provide a collaborative environment to advance the Consortium research agenda and build on these unique strengths: (1) a state-of-the-art infrastructure of flexible tools, processes, and systems developed by RTI that are currently being used by the proposed Clinical Sites for other multisite studies and that will be further customized to meet the unique needs of the Consortium; (2) an administrative structure that provides staffing flexibility to optimally deploy personnel resources and respond quickly to changing Consortium needs; and (3) a proven track record of collaboration and substantial scientific productivity with the proposed Clinical Site PD/PIs, all members along with the proposed RTI staff of the NICHD Neonatal Research Network, that has frequently changed clinical practice.
Limited data are available on effects of in utero opioid exposure beyond the newborn period. The Outcomes of Babies with Opioid Exposure (OBOE) Study will examine longitudinal developmental outcomes of infants exposed to opioids in utero and unexposed infants from birth to 2 years of age. As the Administrative Core for the Data Coordinating Center, RTI International will maximize the productivity of the Helping to End Addiction Long-term (HEAL) Initiative: Antenatal Opioid Exposure Longitudinal Study Consortium by providing logistical support for day-to-day functioning and for meetings and conference calls, fostering effective communication, facilitating collaboration, coordinating external services, developing and maintaining a Consortium website, and managing Clinical Site capitation through the implementation of an efficient and accurate payment system.
