Project 4: Neonatal Abstinence Syndrome (NAS): Fetus to First Years

项目 4：新生儿戒断综合症 (NAS)：胎儿到一岁

• 批准号: 10006605
• 负责人: Adam James Czynski
• 金额: $ 48.33万
• 依托单位: RHODE ISLAND HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-01 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10006605
• 关键词: Acupuncture Therapy; Address; Affect; Assessment tool; Buprenorphine; Caring; Centers of Research Excellence; Child Abuse and Neglect; Clinic; Communities; Counseling; Decision Making; Development; Double-Blind Method; Enrollment; Environment; Epidemic; Exposure to; Family; Fetus; Foundations; Gender; Goals; Guidelines; Health Care Costs; Health Professional; Home environment; Infant; Inpatients; Insurance; Intervention; Kangaroo-Mother Care; Length; Length of Stay; Life; Life Stress; Location; Massage; Measures; Medical; Methadone; Modeling; Morphine; Mothers; Nature; Neonatal Abstinence Syndrome; Newborn Infant; Nurseries; Opiate Addiction; Opioid; Outcome; Outpatients; Perinatal; Pharmaceutical Preparations; Pharmacological Treatment; Pharmacology; Pharmacotherapy; Pregnant Women; Prejudice; Prenatal care; Protocols documentation; Public Health; Randomized; Randomized Controlled Trials; Risk; Risk stratification; Severities; Skin; Standardization; Testing; Treatment Protocols; Variant; Vulnerable Populations; Weaning; Withdrawal; Work; adverse event risk; antenatal; base; buprenorphine treatment; child protective service; classification trees; comparative effectiveness; control trial; cost; design; evidence base; improved; improved outcome; in utero; individualized medicine; interdisciplinary approach; methadone treatment; morphine equivalent; multidisciplinary; neglect; non-compliance; novel; opioid epidemic; opioid exposure; opioid misuse; opioid overdose; opioid use disorder; opioid use in pregnancy; postnatal; prenatal; prevent; programs; regression trees; safety assessment; socioeconomics; support network; tool; treatment program; treatment strategy; trial comparing

PROJECT SUMMARY Opioid use disorders are a public health concern of epidemic proportion. Our project will contribute significantly to this COBRE Center on Opioids and Overdose, as misuse of opioids during pregnancy effects infants, our most vulnerable population. The focus of this project is on Neonatal Abstinence Syndrome (NAS), the withdrawal that infants suffer after being born to a mother who is dependent on opioids. NAS has increased fivefold since 2000, now affecting 60-80% of infants exposed to opioids in utero. The cost to treat NAS in 2012 was $1.5 billion with the majority of infants enrolled in state sponsored insurance programs. NAS is typically treated by the reintroduction of opioids (morphine or methadone and more recently, buprenorphine) followed by gradual weaning and increasingly with non-pharmacological interventions as well (e.g. rooming-in). Unfortunately, treatments are not evidence-based and there are no standardized protocols resulting in a wide variability in the management of these infants and the potential for mismanagement. The overall objective of this proposal is to develop the evidence based tools needed to define best practice and develop a standardized approach to improve the treatment and management of infants with NAS. Our central hypothesis is that establishment of a standardized perinatal to postnatal treatment program for maternal opioid dependency and the management of NAS will shorten length of stay and length of treatment, reduce health care costs, and prevent or mitigate potential adverse long term neurodevelopmental outcomes. In this project we propose to 1) develop a multi- disciplinary, buprenorphine-based prenatal care model for pregnant women being treated for opioid use disorders, 2) conduct a single center randomized control trial of buprenorphine vs. morphine for NAS, and 3) develop a preliminary Risk Stratification Safety Assessment tool (RSSA), using Classification and Regression Tree (CART) statistical decision making analysis to help determine which families are most at risk of medication noncompliance. By tailoring treatment prenatally and removing barriers to novel interventions and working synergistically with the Cores we will transform our current approach the treatment and management of NAS.

项目摘要 类阿片使用障碍是一种流行性的公共卫生问题。我们的项目将大大有助于 到这个COBRE阿片类药物和过量中心，由于怀孕期间滥用阿片类药物会影响婴儿，我们 最脆弱的人群。该项目的重点是新生儿戒断综合征（NAS）， 依赖阿片类药物的母亲所生下的婴儿所遭受的痛苦。自2010年以来， 2000年，现在影响60-80%的婴儿在子宫内暴露于阿片类药物。2012年治疗NAS的费用为15亿美元 大多数婴儿参加了国家赞助的保险计划。NAS通常由 重新引入阿片类药物（吗啡或美沙酮，最近，丁丙诺啡），然后逐渐 断奶和越来越多的非药物干预（如同屋）。不幸的是， 治疗不是以证据为基础的，也没有标准化的方案，导致治疗的广泛差异。 这些婴儿的管理和管理不善的可能性。本建议的总体目标是 开发确定最佳做法所需的基于证据的工具，并制定标准化方法， 改善NAS患儿的治疗和管理。我们的中心假设是， 标准化的围产期到产后治疗计划，用于孕产妇阿片类药物依赖和管理 NAS将缩短住院时间和治疗时间，降低医疗保健成本，并预防或减轻 潜在的不良长期神经发育结果。在这个项目中，我们建议1）开发一个多- 针对因使用阿片类药物而接受治疗的孕妇的基于丁丙诺啡的纪律性产前护理模式 2）进行丁丙诺啡与吗啡治疗NAS的单中心随机对照试验，以及3） 使用分类和回归，开发初步的风险分层安全评估工具（RSSA） 树（CART）统计决策分析，以帮助确定哪些家庭是最危险的药物 不服从通过产前定制治疗，消除新干预措施的障碍， 协同核心，我们将改变我们目前的做法，治疗和管理的NAS。