UAB Clinical Site HEAL Neonatal Opioid Withdrawal Pharmacological Treatments

UAB 临床站点 HEAL 新生儿阿片类药物戒断药物治疗

• 批准号: 10891299
• 负责人: Namasivayam Ambalavanan
• 金额: $ 22.15万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 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/10891299
• 关键词: UAB; Clinical; Site; HEAL; Neonatal

Project Summary Many infants exposed to opioids antenatally develop Neonatal Opioid Withdrawal Syndrome (NOWS). The overarching goal of the HEAL Initiative: Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial – Clinical Sites (UG1 Clinical Trial Required) as stated in RFA-HD-21-031 is to design and implement a multi-center, comparative effectiveness, randomized controlled trial (RCT) to assess the optimal pharmacological treatment for NOWS. Our clinical site at the University of Alabama at Birmingham (UAB) is a Regional Perinatal Center with a Comprehensive Addiction in Pregnancy Program (CAPP) that can enroll a large cohort of infants with NOWS. UAB is also actively enrolling in the UAB Outcomes of Babies with Opioid Exposure (OBOE) in response to HEAL Initiative: Antenatal Opioid Exposure Longitudinal Study Consortium (RFA- HD-19-025) and the ACT NOW Weaning study. As a center in the NICHD Neonatal Research Network (NRN) for >25 years, our clinical site has long-standing established productive collaborations with many other clinical centers. Our center has an excellent track record of enrollment in clinical studies (#1 or 2 in most NRN trials) with successful follow-up to 2 years of age and beyond, with trained certified examiners for neurodevelopment. Our investigational pharmacy has worked with us on multiple trials. Therefore, there is demonstrated adequacy of clinical, administrative and data organizational management facilities. For this delayed onset clinical trial, the final protocol will be developed in coordination with the other Clinical Sites and the DCC. We clearly express our intent to participate in a cooperative manner with the other Clinical Centers, the DCC, the NIH, and the DSMC in all aspects of research in a manner consistent with the terms of the award. The Specific Aims are: Specific Aim 1: To develop a protocol in coordination with the other Clinical Sites and the DCC, to compare morphine, methadone, and buprenorphine, while taking into account non-pharmacologic factors and adjunct therapies for the management of neonatal opioid withdrawal syndrome. Specific Aim 2: To recruit and enroll infants with neonatal opioid withdrawal syndrome at our clinical site in the randomized controlled trial, and measure important short-term outcomes by hospital discharge. Specific Aim 3: (A) To determine important neurodevelopmental and other clinical, social, and environmental outcomes in enrolled infants at two-year follow-up outcomes; and (B) In collaboration with the other Clinical Sites and the DCC, to disseminate findings of the clinical trial and help develop evidence-based clinical practice guidelines.

项目摘要 许多婴儿在产前接触阿片类药物后患上新生儿阿片类药物戒断综合征 (现在)。治愈行动的首要目标：新生儿阿片类药物戒断综合征 药物治疗疗效比较试验-临床试验(UG1临床试验 必需)如RFA-HD-21-031中所述，设计和实施多中心、可比较 评估最佳药物治疗的有效性、随机对照试验(RCT) 对于NOWS。我们在阿拉巴马大学伯明翰分校(UAB)的临床站点是地区性围产儿 拥有全面孕期成瘾计划(CAPP)的中心可以招收大量的 患有NOWS的婴儿。UAB还积极参与阿片类药物暴露的婴儿的UAB结果 (双簧管)对Hear倡议的回应：产前阿片类药物暴露纵向研究联盟(RFA- HD-19-025)和ACT Now断奶研究。作为NICHD新生儿研究网络的中心 (NRN)25年来，我们的临床站点与许多 其他临床中心。我们中心在临床研究方面有着良好的招生记录(排名第一或第二 大多数NRN试验)，成功随访到2岁及以上，并有训练有素的认证检查员 用于神经发育。我们的研究药房已经与我们合作进行了多项试验。因此， 已证明临床、行政和数据组织管理设施充足。 对于这项延迟开始的临床试验，最终方案将与另一项方案协调制定 临床站点和疾病控制中心。我们明确表示愿意以合作的方式与 其他临床中心、DCC、NIH和DSMMC在所有方面的研究都保持一致 关于获奖条款的问题。具体目标是： 具体目标1：与其他临床站点和DCC协调制定一项协议， 比较吗啡、美沙酮和丁丙诺啡，同时考虑非药理学因素 新生儿阿片类药物戒断综合征的处理因素和辅助治疗。 具体目标2：招募和登记患有新生儿阿片类药物戒断综合征的婴儿 随机对照试验中的临床地点，并由医院衡量重要的短期结果 出院。 具体目标3：(A)确定重要的神经发育和其他临床、社会和 登记婴儿的两年随访结果中的环境结果；和(B)合作 与其他临床站点和DCC一起传播临床试验的结果并帮助开发 循证临床实践指南。