Thomas Jefferson University Hospital Clinical Site for HEAL NOWS Pharmacologic Trial

项目摘要 托马斯杰斐逊大学医院（TJUH）是托马斯杰斐逊的主要临床校园 大学（TJU），并将作为临床网站的“愈合倡议：新生儿阿片类药物戒断 综合征药理学治疗比较有效性试验-临床研究中心”RFA- HD-21=031。该网站将由共同PI结构的沃尔特卡夫，医学博士（TJU）和苏珊 Adeniyi-Jones，医学博士（TJU和Nemours at Jefferson）。TJU拥有40年的领导历史， 孕期阿片类药物使用障碍的护理优化途径 治疗、教育和研究（MATER）方案，对200名以上的产妇进行普查; 妇女目前的研究小组一直是进行临床试验的领导者， 新生儿阿片类戒断综合征（NOWS）的最佳药物治疗。这 工作包括新生儿首次使用和药理学驱动的剂量优化 丁丙诺啡TJU在最近完成的AIM 2NAS研究中是全国最大的注册者 研究昂丹司琼作为药物辅助剂以减轻NOWS症状。这些临床 试验，沿着遗传样本收集工作，已经在NOWS中招募了450多名婴儿 相关研究。TJUH从事最大的非药物治疗，并有一个完善的 围绕NOWS护理的质量评估和改进计划。有一个强大的连续体 在分娩前、分娩期间和分娩后为患有阿片类药物使用障碍的妇女提供支持的护理。这 支持性文化导致同意参加临床试验的比例很高（约70%的 接触的母亲），以便对婴儿进行纵向跟踪。神经发育 评估可用于费城三州地区集水区的婴儿。的 研究团队在多中心临床试验的实施和设计方面经验丰富， 数据安全监测委员会的运作。调查人员已经参与了国家 以及致力于优化NOWS护理的国际财团。

Project Summary Thomas Jefferson University Hospital (TJUH) is the main clinical campus of Thomas Jefferson University (TJU) and will serve as clinical site for the “HEAL Initiative: Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial - Clinical Sites” RFA- HD-21=031. The site will be led by the co-PI structure of Walter Kraft, MD (TJU) and Susan Adeniyi-Jones, MD (TJU and Nemours at Jefferson). TJU has a 40-year history of leadership in optimizing approaches to the care opioid use disorder in pregnancy at the Maternal Addiction Treatment, Education, and Research (MATER) program, which carries a maternal census of >200 women. The current investigative team has been leaders in conducting clinical trials examining the optimal pharmacological treatments for neonatal opioid withdrawal syndrome (NOWS). This work has included neonatal first use and pharmacometric driven dose optimization of buprenorphine. TJU was the national top enroller in the recently completed AIM2NAS study examining ondansetron as pharmacologic adjunct to reduce NOWS symptoms. These clinical trials, along with work in genetic sample collection, have enrolled over 450 infants in NOWS related research. TJUH engages in maximal non-pharmacologic care and has a well-established quality assessment and improvement program around NOWS care. There is a robust continuum of care that supports women with opioid use disorders before, during, and after delivery. This supportive culture has resulted in high rate of agreeing to participate in clinical trials (~70% of mothers approached) allows for longitudinal follow up of infants. Neurodevelopmental assessment is available for infants across the tri-state region catchment area of Philadelphia. The investigative team is experienced in the conduct and design of multi-center clinical trials and of data safety monitoring board functioning. The investigators have has been involved in national and international consortia dedicated to optimizing care in NOWS.