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: 10372486
• 负责人: Namasivayam Ambalavanan
• 金额: $ 44.29万
• 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 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10372486
• 关键词: 2 year old; Alabama; Award; Birth; Budesonide; Buprenorphine; Clinical; Clinical Practice Guideline; Clinical Research; Clinical Trials; Clonidine; Collaborations; Data; Diagnosis; Discipline of obstetrics; Drug usage; Enrollment; Ethnic group; Exposure to; Funding; Gestational Age; Goals; Helping to End Addiction Long-term; Hospitals; Infant; Infant Care; Institutes; Investigation; Longitudinal Studies; Measures; Medicine; Methadone; Morphine; Mothers; Multicenter Neonatal Research Network; Multicenter Studies; Multicenter Trials; National Heart, Lung, and Blood Institute; National Institute of Child Health and Human Development; National Institute of Diabetes and Digestive and Kidney Diseases; Neonatal; Neonatal Abstinence Syndrome; Neonatal Intensive Care Units; Newborn Infant; Opioid; Outcome; Perinatal; Pharmaceutical Preparations; Pharmacological Treatment; Pharmacology; Pharmacy facility; Phenobarbital; Pregnancy; Protocols documentation; Randomized Controlled Trials; Regimen; Research; Site; Training; United States National Institutes of Health; Universities; Variant; Weaning; Work; addiction; antenatal; clinical application; clinical center; clinical research site; cohort; comparative effectiveness; comparative effectiveness trial; design; effectiveness clinical trial; evidence base; experience; follow-up; high risk infant; in utero; neurodevelopment; opioid exposure; opioid use; opioid withdrawal; participant retention; patient population; payment; prevent; programs; racial and ethnic; recruit; response; social; socioeconomics

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 许多暴露于阿片类药物的婴儿解剖发展了新生儿阿片类药物戒断综合征 （现在）。 Heal倡议的总体目标：新生儿阿片类药物戒断综合征 药理治疗比较有效性试验 - 临床部位（UG1临床试验） RFA-HD-21-031中所述）是设计和实施多中心的比较 有效性，随机对照试验（RCT）评估最佳药物治疗 现在。我们在阿拉巴马大学伯明翰（UAB）的临床场所是区域围产期 中心具有全面的妊娠计划成瘾（CAPP），可以参加大量队列 现在有婴儿。 UAB还在积极参与阿片类药物暴露的婴儿的UAB结果 （双簧管）响应Heal Initiative：产前阿片类药物暴露纵向研究联盟（RFA- HD-19-025）和该法案现在断奶研究。作为NICHD新生儿研究网络的中心 （NRN）> 25年以上，我们的临床网站与许多人建立了长期建立的产品合作 其他临床中心。我们的中心在临床研究中的入学率很高（＃1或2 大多数NRN试验）与经过培训的认证审查员成功进行了2岁及以后的成功随访 用于神经发育。我们的调查药房已与我们合作进行了多项试验。所以， 临床，行政和数据组织管理设施的适当性证明了适当性。 对于这项延迟的发作临床试验，将制定最终方案 临床部位和DCC。我们清楚地表达了与与 其他临床中心，DCC，NIH和DSMC在研究的各个方面都以一致 带有奖项的条款。具体目的是： 特定目的1：与其他临床部位和DCC协调制定协议， 比较吗啡，方法载体和丁丙诺啡，同时考虑了非药物 新生儿阿片类药物戒断综合征管理的因素和辅助疗法。 特定目的2：在我们的 随机对照试验中的临床部位，并测量医院的重要短期结局 释放。 特定目的3：（a）确定重要的神经发育和其他临床，社会和 在两年的随访结果中，入学婴儿的环境结果； （b）合作 随着其他临床部位和DCC，以传播临床试验的发现并有助于发展 基于证据的临床实践指南。