HEAL initiative: Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial: Cincinnati site

HEAL 计划：新生儿阿片类药物戒断综合征药理学治疗比较有效性试验：辛辛那提网站

• 批准号: 10377726
• 负责人: STEPHANIE L MERHAR
• 金额: $ 47.45万
• 依托单位: CINCINNATI CHILDRENS HOSP MED CTR
• 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/10377726
• 关键词: 2 year old; Age; Brain; Buprenorphine; Child Development; Clinic; Clinical Pharmacology; Clinical Research; Clinical Research Protocols; Clinical Services; Clinical Trials; Collaborations; Data; Development; Drug Kinetics; Eating; Effectiveness; Enrollment; Epidemic; Exposure to; Faculty; Future; Helping to End Addiction Long-term; Hospitalists; Infant; Infant Development; Inpatients; Institutes; Kentucky; Length; Length of Stay; Live Birth; Medical center; Methadone; Morphine; Multicenter Neonatal Research Network; Neonatal; Neonatal Abstinence Syndrome; Newborn Infant; Ohio; Opioid; Outcome; Outpatients; Pediatric Hospitals; Perinatal; Pharmaceutical Preparations; Pharmacological Treatment; Pharmacology; Physician Executives; Population; Productivity; Protocols documentation; Randomized; Research; Research Personnel; Services; Site; Sleep; Standardization; Structure; Treatment Protocols; base; behavioral outcome; buprenorphine treatment; clinical care; clinical research site; comparative effectiveness; comparative effectiveness trial; design; experience; fetal opioid exposure; follow-up; infant outcome; innovation; member; methadone treatment; neuroimaging; opioid exposure; opioid overdose; optimal treatments; overdose death; personalized medicine; pharmacodynamic biomarker; phase 1 study; population based; prenatal; programs; recruit; response

PROJECT SUMMARY/ABSTRACT The number of infants exposed to opioids prenatally in the US remains high, with one infant born exposed to opioids every 15 minutes. Optimal treatment for exposed infants who develop neonatal opioid withdrawal syndrome (NOWS) has not been established, and randomized comparative effectiveness trials of medications for NOWS are critically needed. Cincinnati Children’s Hospital Medical Center (CCHMC) is uniquely suited to participate as a clinical site in such a multicenter randomized comparative effectiveness trial. The CCHMC Perinatal Institute is a large regional perinatal center, providing population-based clinical service for approximately 25,000 newborns each year. Intrauterine exposure to opioids in the Cincinnati region was approximately 26 per 1000 live births in 2020, with 10.3 per 1000 developing NOWS requiring pharmacologic treatment. The proposed PI for this study Stephanie Merhar, proposed alternate PI Scott Wexelblatt, and proposed follow-up PI Jennifer McAllister all have extensive experience in clinical care, quality improvement, and clinical research in the NOWS population. The Cincinnati team will provide significant intellectual contributions to the design of the study, recruit a large number of infants with NOWS to participate, and continue our tradition of excellent follow-up rates to retain infants in the study to age 2. The expertise and experience of the investigators and support staff, along with the facilities and population available for study at CCHMC, make CCHMC a strong site for this proposed study.

项目总结/摘要 在美国，产前暴露于阿片类药物的婴儿数量仍然很高， 每15分钟注射一次阿片类药物暴露婴儿出现新生儿阿片类戒断的最佳治疗 综合征（NOWS）尚未建立，药物的随机比较有效性试验 NOWS是非常需要的。辛辛那提儿童医院医疗中心（CCHMC）非常适合 作为临床试验机构参与此类多中心随机有效性比较试验。CCHMC 围产研究所是一个大型的区域性围产中心，提供以人群为基础的临床服务， 每年大约有25，000名新生儿。在辛辛那提地区， 到2020年，每1000例活产中约有26例，每1000例发展中的NOWS中有10.3例需要药物治疗。 治疗本研究的拟定PI Stephanie Merhar、拟定替代PI Scott Wexelblatt和 拟定随访PI Jennifer麦卡利斯特均在临床护理、质量改进、 和NOWS人群的临床研究。辛辛那提队将提供重要的智力 为研究的设计做出贡献，招募了大量患有NOWS的婴儿参与，并继续 我们的优良传统随访率，以保持婴儿在研究中2岁。的专门知识和经验 研究者和支持人员，沿着CCHMC可用于研究的设施和人群， CCHMC是这项拟议研究的有力研究中心。