HEAL initiative: Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial: Cincinnati site

项目摘要/摘要 在美国，产前接触阿片类药物的婴儿数量仍然很高，出生时就有一名婴儿接触到阿片类药物 每15分钟服用一次阿片类药物。新生儿阿片类药物戒断后暴露婴儿的最佳治疗 综合征(NOWS)尚未建立，药物的随机比较有效性试验 因为NOW是迫切需要的。辛辛那提儿童医院医疗中心(CCHMC)是唯一适合 作为临床站点参与这样的多中心随机比较有效性试验。CCHMC 围产期研究所是一个大型的地区性围产期中心，为 每年大约有25,000名新生儿。辛辛那提地区宫内接触阿片类药物 到2020年，每1000名活产儿中约有26人，每1000名发展中的新生儿中有10.3人需要药理 治疗。本研究的拟议PI为Stephanie Merhar，提议的候补PI Scott Wexelblatt，以及 建议的跟进派珍妮弗·麦卡利斯特都在临床护理、质量改进、 以及在NOWS人群中的临床研究。辛辛那提团队将提供重要的智力 对研究设计的贡献，招募大量NOWS婴儿参与，并继续 我们优秀的随访率将婴儿保留在研究中至2岁的传统。 调查人员和支持人员，以及CCHMC可供学习的设施和人口，使 CCHMC是这项拟议研究的有力网站。

PROJECT SUMMARY/ABSTRACT The number of infants exposed to opioids prenatally in the US remains high, with one infant born exposed to opioids every 15 minutes. Optimal treatment for exposed infants who develop neonatal opioid withdrawal syndrome (NOWS) has not been established, and randomized comparative effectiveness trials of medications for NOWS are critically needed. Cincinnati Children’s Hospital Medical Center (CCHMC) is uniquely suited to participate as a clinical site in such a multicenter randomized comparative effectiveness trial. The CCHMC Perinatal Institute is a large regional perinatal center, providing population-based clinical service for approximately 25,000 newborns each year. Intrauterine exposure to opioids in the Cincinnati region was approximately 26 per 1000 live births in 2020, with 10.3 per 1000 developing NOWS requiring pharmacologic treatment. The proposed PI for this study Stephanie Merhar, proposed alternate PI Scott Wexelblatt, and proposed follow-up PI Jennifer McAllister all have extensive experience in clinical care, quality improvement, and clinical research in the NOWS population. The Cincinnati team will provide significant intellectual contributions to the design of the study, recruit a large number of infants with NOWS to participate, and continue our tradition of excellent follow-up rates to retain infants in the study to age 2. The expertise and experience of the investigators and support staff, along with the facilities and population available for study at CCHMC, make CCHMC a strong site for this proposed study.