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 许多婴儿在出生前暴露于阿片类药物， （NOWS）。HEAL倡议的总体目标：新生儿阿片类戒断综合征 药物治疗比较有效性试验-临床研究中心（UG 1临床试验 RFA-HD-21-031中规定的要求）是设计和实施多中心、比较 有效性，随机对照试验（RCT），以评估最佳药物治疗 对于NOWS。我们在伯明翰的亚拉巴马大学（UAB）的临床站点是一个区域围产期 该中心拥有一个全面的妊娠成瘾计划（CAPP），可以招募大量的 婴儿NOWS UAB还积极参加UAB阿片类药物暴露婴儿的结局 （OBOE）响应HEAL倡议：尿道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，我们的临床研究中心与许多 其他临床中心。我们的中心在临床研究中有着良好的入组记录（排名第1或第2）。 大多数NRN试验），成功随访至2岁及以上，由经过培训的认证检查员进行 for neurodevelopment神经发育.我们的研究药房与我们合作进行了多项试验。因此，我们认为， 已证明临床、行政和数据组织管理设施充分。 对于这项延迟发作的临床试验，将与其他研究人员协调制定最终方案。 临床研究中心和DCC。我们明确表示，我们打算以合作的方式参与， 其他临床中心、DCC、NIH和DSMC在研究的各个方面以一致的方式 对裁决的条款有意见具体目标是： 具体目标1：与其他临床研究中心和DCC协调制定方案， 比较吗啡、美沙酮和丁丙诺啡，同时考虑非药理学 新生儿阿片类药物戒断综合征的管理因素和辅助治疗。 具体目标2：在我们的研究中招募和入组患有新生儿阿片类戒断综合征的婴儿 随机对照试验中的临床研究中心，并按医院衡量重要的短期结局 放电 具体目标3：（A）确定重要的神经发育和其他临床、社会和 2年随访结果时入组婴儿的环境结局;（B）合作 与其他临床研究中心和DCC合作，传播临床试验结果，并帮助开发 循证临床实践指南。