Neonatal Opioid Withdrawal Syndrome (NOWS) in Kentucky: Improving Outcomes for Infants

肯塔基州新生儿阿片类药物戒断综合症 (NOWS)：改善婴儿的预后

• 批准号: 10891301
• 负责人: Lori Ann Devlin-Phinney
• 金额: $ 22.89万
• 依托单位: UNIVERSITY OF LOUISVILLE
• 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/10891301
• 关键词: Neonatal; Opioid; Withdrawal; Syndrome; NOWS

PROJECT SUMMARY/ABSTRACT The medical and non-medical use of opioids and other psychoactive drugs in women of childbearing age is a significant public health concern in the United States. Prolonged in utero exposure of the developing fetus to maternal opioids often results in Neonatal Opioid Withdrawal Syndrome (NOWS) after delivery. Infants with NOWS may have mild signs of withdrawal that minimally impact their ability to function or they may have significant withdrawal that requires a prolonged course of pharmacologic therapy and a lengthy newborn hospital stay which stresses families, communities, and the healthcare system. Prolonged hospitalization may result in decreased maternal and infant bonding and attachment and have a negative impact on neurodevelopmental and behavioral outcomes of affected children. The prevalence of opioid use during pregnancy and the subsequent occurrence of NOWS after delivery is disproportionately higher in rural and underserved areas. Kentucky is a highly rural and underserved state and has an estimated rate of NOWS that is approximately three times the national average. Despite the significance of this problem, the clinical care for neonates with NOWS is complicated by a lack of nationally accepted standardized approaches which leads to significant site-to-site variation. Such variation is due in part to a lack of generalizable evidence to inform clinical practice. Previous research has been limited by both small sample sizes, due to difficulty with recruitment and retention, and inherent limitations in study designs. In order to identify the most effective treatment and thereby optimize the care of infants with NOWS, a direct comparison of pharmacologic treatment regimens in a generalizable population is urgently needed. Collaboration with local community partners and with other clinical sites will be undertaken within the proposed research consortium to design, implement, and conduct a multicenter randomized controlled clinical trial. The goal of the trial is to provide a direct comparison of pharmacologic treatment for infants with NOWS, account for confounding variables such as non-pharmacologic care and adjuvant medications and evaluate neurodevelopmental and behavioral outcomes in the first years of life. The anticipated results of this RCT will be highly generalizable to improve care for infants with NOWS in KY and throughout the nation.

项目总结/摘要 育龄妇女在医疗和非医疗方面使用阿片类药物和其他精神药物的情况， 这是美国一个重大的公共卫生问题。发育中的胎儿在子宫内长期暴露于 母体阿片类药物常常导致分娩后的新生儿阿片类药物戒断综合征（NOWS）。婴幼儿 NOWS可能有轻微的戒断症状，对他们的功能影响最小，或者他们可能有 需要延长药物治疗疗程和漫长的新生儿住院时间的显著停药 留下来给家庭、社区和医疗保健系统带来压力。长期住院可能导致 减少母婴的联系和依恋，对神经发育和 受影响儿童的行为结果。妊娠期间阿片类药物使用的流行率以及随后的 分娩后NOWS的发生率在农村和服务不足地区不成比例地高。肯塔基州是 高度农村和服务不足的状态，并有估计的NOWS率约为三倍， 全国平均水平 尽管这个问题的重要性，临床护理新生儿与NOWS是复杂的缺乏 国家接受的标准化方法，导致显着的网站之间的差异。这种变化是 部分原因是缺乏可推广的证据来告知临床实践。以前的研究受到限制， 由于招募和保留困难以及研究设计的固有局限性，样本量较小。 为了确定最有效的治疗方法，从而优化NOWS婴儿的护理， 迫切需要在可推广的人群中进行药物治疗方案的比较。 与当地社区合作伙伴和其他临床站点的合作将在 建议的研究联盟设计，实施和进行多中心随机对照临床试验， 审判该试验的目的是为患有NOWS的婴儿提供药物治疗的直接比较， 考虑混杂变量，如非药物治疗和辅助药物，并评估 在生命的最初几年的神经发育和行为结果。本RCT的预期结果为 高度概括性，以改善护理婴儿与NOWS在肯塔基州和全国各地。