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: 10380355
• 负责人: Lori Ann Devlin-Phinney
• 金额: $ 46.55万
• 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 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10380355
• 关键词: Accounting; Address; Adjuvant Analgesic; Affect; Caring; Child; Childhood; Clinic; Clinical; Clinical Nursing Research; Clinical Pharmacology; Clinical Practice Guideline; Clinical Research; Clinical Trials; Clinical Trials Network; Collaborations; Communities; Community Healthcare; Confounding Factors (Epidemiology); Country; Data Analyses; Development; Dose; Enrollment; Ensure; Evaluation; Family; Female of child bearing age; Fetal Development; Frequencies; Geography; Goals; Health; Health Personnel; Healthcare Systems; Hospitalization; Hospitals; Infant; Infant Care; Infrastructure; Kentucky; Leadership; Length of Stay; Life; Medical; Medical Care Team; Mothers; Multi-Institutional Clinical Trial; Multi-site clinical study; Neonatal; Neonatal Abstinence Syndrome; Neonatal Intensive Care Units; Newborn Infant; Opioid; Outcome; Patient Recruitments; Patients; Pharmacological Treatment; Pharmacology; Play; Population; Population Heterogeneity; Pregnancy; Prevalence; Psychotropic Drugs; Public Health; Randomized; Randomized Controlled Clinical Trials; Recording of previous events; Research; Research Design; Research Personnel; Role; Rural; Sample Size; Scientist; Site; Solid; Standardization; Stress; Time; Treatment Protocols; United States; United States National Institutes of Health; Universities; Variant; Visit; Withdrawal; Work; behavioral outcome; care outcomes; clinical care; clinical practice; clinical research site; clinically relevant; comparative effectiveness trial; compare effectiveness; control trial; data sharing; design; effective therapy; evidence base; experience; follow-up; high risk; improved; improved outcome; infant outcome; member; neonate; opioid epidemic; opioid misuse; opioid use; opioid use in pregnancy; optimal treatments; outreach; pediatric department; pediatrician; prenatal exposure; programs; prospective; recruit; rural area; rural underserved; standard of care; suburb; underserved area; urban underserved

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.

项目摘要/摘要 阿片类药物的医学和非医疗用途以及育龄女性的其他精神药物是 在美国，一个重大的公共卫生问题。长时间在子宫内胎儿暴露于 孕产妇阿片类药物经常导致新生儿阿片类药物戒断综合征（现在）。婴儿 现在可能有轻度撤离迹象，这些迹象最小而影响其功能的能力，或者他们可能具有 需要长时间的药理学治疗和漫长的新生儿医院的大量戒断 留下强调家庭，社区和医疗保健系统。长时间住院可能会导致 减少母亲和婴儿的粘结和依恋，对神经发育和 受影响儿童的行为结果。怀孕期间阿片类药物使用的患病率和随后的患病率 在农村和服务不足的地区，分娩后的现在的发生不成比例。肯塔基是一个 高度农村和服务不足的状态，估计的现在速率约为 全国平均水平。 尽管这个问题具有重要意义，但缺乏现在对NOTS的新生儿的临床护理很复杂 全国接受的标准化方法，导致现场对地点的重大变化。这种变化是 部分原因是缺乏可为临床实践提供信息的证据。以前的研究受到 两个小样本量由于难以招募和保留率以及研究设计中的固有局限性。 为了识别最有效的治疗，从而优化了现在的婴儿护理，直接 迫切需要对可推广人群中药理治疗方案的比较。 将与当地社区合作伙伴以及其他临床站点合作 拟议的研究联盟，以设计，实施和进行多中心随机对照临床 审判。该试验的目的是直接比较患有NOW的婴儿的药理治疗， 解释混淆变量，例如非药物护理和辅助药物，并评估 在生命的头几年，神经发育和行为结果。此RCT的预期结果将是 高度推广，可以改善肯塔基州和全国各地的婴儿的护理。