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: 10378979
• 负责人: Susan Adeniyi-Jones
• 金额: $ 31.62万
• 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 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10378979
• 关键词: Affect; Aftercare; Behavior; Biological Assay; Birth; Blood Volume; Buprenorphine; Caring; Catchment Area; Censuses; Childhood; Clinic; Clinical; Clinical Pharmacology; Clinical Psychology; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Clinical Trials Design; Collaborations; Conduct Clinical Trials; Consensus; Consent; Continuity of Patient Care; Data; Data Analyses; Dose; Drug Formulations; Drug Kinetics; Drug Stability; Elements; Enrollment; Ethics; Experimental Psychology; Exposure to; Faculty; Family; Floor; Funding; Funding Agency; Genetic; Geography; Health; Health system; Helping to End Addiction Long-term; Hospitals; Incidence; Individual; Infant; Infant Health; Infrastructure; Institutional Review Boards; International; Intervention; Investigation; Journals; Leadership; Link; Maternal Exposure; Measures; Modeling; Monitor; Morphine; Mothers; Multi-Institutional Clinical Trial; National Institute of Drug Abuse; Neonatal; Neonatal Abstinence Syndrome; Neonatology; Newborn Infant; Nurseries; Nurses; Ondansetron; Opioid; Patients; Performance; Pharmaceutical Preparations; Pharmacological Treatment; Pharmacology; Philadelphia; Pregnancy; Productivity; Protocols documentation; Public Health; Publications; Publishing; Randomized Controlled Trials; Recording of previous events; Regimen; Registries; Rehabilitation therapy; Research; Research Design; Research Personnel; Sampling; Severities; Site; Standardization; Structure; Substance Use Disorder; Substance abuse problem; Supportive care; Symptoms; Therapeutic; Time; Universities; University Hospitals; Visit; Woman; Work; addiction; assay development; clinical research site; comparative; comparative effectiveness; comparative effectiveness trial; design; education research; effectiveness clinical trial; experience; feeding; follow-up; improved; in utero; innovation; instrument; investigator-initiated trial; large datasets; member; neonate; novel; opioid exposure; opioid use disorder; patient population; pharmacometrics; programs; sample collection; social stigma; stem; treatment optimization; ward

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.

项目概要 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 大学（TJU）并将作为“HEAL 计划：新生儿阿片类药物戒断”的临床中心 综合征药物治疗效果比较试验 - 临床站点”RFA- HD-21=031。该网站将由医学博士 Walter Kraft（TJU）和 Susan 的联合 PI 领导 Adeniyi-Jones，医学博士（TJU 和 Jefferson 的 Nemours）。 TJU 拥有 40 年的领导历史 优化孕产妇成瘾妊娠期阿片类药物使用障碍的护理方法 治疗、教育和研究 (MATER) 计划，对超过 200 名孕产妇进行普查 女性。目前的研究团队一直是开展临床试验检查的领导者 新生儿阿片类药物戒断综合征（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 是最近完成的 AIM2NAS 研究的全国顶尖招募者 检查昂丹司琼作为药理学辅助剂以减轻NOWS 症状。这些临床 试验以及基因样本收集工作已在NOWS 中招募了超过 450 名婴儿 相关研究。 TJUH 致力于最大程度的非药物护理，并拥有完善的 围绕NOWS 护理的质量评估和改进计划。存在一个稳健的连续体 为产前、产中和产后患有阿片类药物使用障碍的妇女提供护理服务。这 支持性文化导致同意参加临床试验的比例很高（约 70% 母亲接近）允许对婴儿进行纵向随访。神经发育 费城三州地区的婴儿均可接受评估。这 研究团队在多中心临床试验的实施和设计方面拥有丰富的经验 数据安全监控委员会运作。调查人员已介入国家 以及致力于优化NOWS 护理的国际联盟。