Thomas Jefferson University Hospital Clinical Site for HEAL NOWS Pharmacologic Trial

托马斯杰斐逊大学医院 HEAL NowS 药理学试验临床基地

• 批准号: 10891298
• 负责人: Susan Adeniyi-Jones
• 金额: $ 15.11万
• 依托单位: THOMAS JEFFERSON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-17 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10891298
• 关键词: Thomas; Jefferson; University; Hospital; Clinical

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.

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区 并将作为“治愈倡议：新生儿阿片类药物戒断”的临床地点 证候药理治疗疗效比较试验-临床网站“RFA- HD-21=031。该网站将由沃尔特·克拉夫特，医学博士(TJU)和苏珊共同领导 Adeniyi-Jones，医学博士(杰斐逊TJU和Nemour)。TJU有40年的领导历史 孕期阿片类药物使用障碍母亲成瘾期护理方法的优化 治疗、教育和研究(MAMER)计划，该计划进行了200人的孕产妇普查 女人。目前的调查小组一直是进行临床试验和检查的领导者 新生儿阿片类药物戒断综合征的最佳药物治疗。这 工作包括新生儿首次使用和药物计量驱动剂量优化 丁丙诺啡。在最近完成的AIM2NAS研究中，TJU是全国最好的参与者 检查恩丹西酮作为减轻NOWS症状的药理辅助剂。这些临床 试验和基因样本收集工作已经在NOWS招募了450多名婴儿 相关研究。TJUH从事最大限度的非药物护理，并拥有完善的 围绕NOWS护理的质量评估和改进计划。有一个强大的连续体 支持患有阿片类药物使用障碍的妇女在分娩前、分娩中和分娩后的护理。这 支持性文化导致了同意参与临床试验的高比率(约70% 与母亲接触)允许对婴儿进行纵向跟踪。神经发育 评估适用于费城三州地区的婴儿。这个 研究团队在进行和设计多中心临床试验和 数据安全监控板运行情况。调查人员已经参与了全国性的 和致力于优化NOWS护理的国际财团。