ECHO Administrative Supplement - Neonatal Opioid Trials

ECHO 行政补充文件 - 新生儿阿片类药物试验

• 批准号: 10459783
• 负责人: Laura Kristin NEWBY
• 金额: $ 150万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-21 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10459783
• 关键词: Address; Administrative Supplement; Affect; Area; Arkansas; Biometry; Caring; Child Health; Childhood; Clinical; Clinical Research; Clinical Trials; Clinical Trials Network; Clinical trial protocol document; Cohort Studies; Collaborations; Consent; Data; Data Coordinating Center; Diagnosis; Eating; Enrollment; Exposure to; Family; Goals; Incidence; Infant; Infant Care; Infrastructure; International; Intervention; Knowledge; Length; Life; Medical; Methadone; Methods; Monitor; Morphine; Multicenter Neonatal Research Network; Muscle Hypertonia; Neonatal; Neonatal Abstinence Syndrome; Neonatal Intensive Care Units; Network Infrastructure; Opioid; Outcome; Pediatrics; Pregnant Women; Principal Investigator; Protocols documentation; Randomized; Randomized Controlled Trials; Reflex action; Research; Research Design; Research Institute; Research Personnel; Resources; Science; Site; Sleep; Time; Treatment outcome; United States National Institutes of Health; Universities; Weaning; Weight Gain; clinical trial participant; design; experience; improved; mid-career faculty; operation; pregnant; prenatal exposure; primary outcome; professor; programs; sucking; waiver

Neonatal opioid withdrawal syndrome (NOWS) has increased more than fivefold since 2000. The dramatic rise in NOWS has occurred in association with an increase in the use of opioids by pregnant women. Little is known about the best methods for identification, monitoring, and treatment of affected infants. The IDeA States Pediatric Clinical Trials Network (ISPCTN), which is part of the Environmental influences on Child Health Outcomes (ECHO) Program, and the Neonatal Research Network (NRN) are uniquely poised to address existing knowledge gaps associated with NOWS. The ISPCTN consists of >20 neonatal intensive care units and the NRN consists of >50 neonatal intensive care units. Both networks have access to investigators, study coordinators, infrastructure, and participants for clinical trials. The Duke Clinical Research Institute (DCRI) serves as the ECHO Coordinating Center and has extensive experience in cohort studies and clinical trials in infants. We will also leverage the expertise of the Data Coordinating and Operations Center (DCOC) of the ISPCTN at the University of Arkansas for Medical Sciences (UAMS). The overall goal of our proposal is to use the infrastructure of the ECHO Program and ISPCTN in collaboration with the NRN to initiate two clinical trials to evaluate interventions to improve the care of infants and families affected by NOWS. Our research team, led by Drs. Brian Smith and Rachel Greenberg at DCRI and Drs. Jeannette Lee and Jessica Snowden at UAMS, will achieve this goal by implementing: 1) a clinical trial protocol evaluating the optimal use of the Eating, Sleeping, Consoling (ESC) care approach on the length of time until infants affected by NOWS are medically ready for discharge; and 2) a clinical trial protocol evaluating whether an early stop weaning protocol for morphine in infants treated for NOWS will decrease the number of days of opioid treatment. Using the highest research standards, we will accomplish the task set out by the NIH to close research gaps in this critically important area. 1 2

自2000年以来，新生儿阿片类药物戒断综合征（NOWS）增加了五倍多。急剧增加 在NOWS中，与孕妇使用阿片类药物的增加有关。之甚少 了解识别、监测和治疗受影响婴儿的最佳方法。IDEA国家 儿科临床试验网络（ISPCTN），这是环境对儿童健康的影响的一部分 结果（ECHO）计划和新生儿研究网络（NRN）是唯一准备解决 与NOWS有关的现有知识差距。ISPCTN由20多个新生儿重症监护病房组成 NRN由50多个新生儿重症监护病房组成。这两个网络都可以接触到调查人员， 临床试验的协调员、基础设施和参与者。杜克临床研究所（DCRI） 作为ECHO协调中心，在以下领域的队列研究和临床试验方面拥有丰富的经验： 婴儿。我们还将利用数据协调和运营中心（DCOC）的专业知识， 阿肯色州医学科学大学（UAMS）的ISPCTN。我们提案的总体目标是利用 ECHO计划和ISPCTN的基础设施与NRN合作，启动两项临床试验 评估干预措施，以改善受NOWS影响的婴儿和家庭的护理。我们的研究团队， DCRI的Brian Smith博士和Rachel Greenberg博士以及UAMS的珍内特李博士和杰西卡斯诺登博士， 将通过实施以下措施实现这一目标：1）临床试验方案，评估进食的最佳使用， 睡眠，安慰（ESC）护理方法对受NOWS影响的婴儿进行医学检查的时间长度 准备出院;和2）临床试验方案，评估是否可以采用早期停止断奶方案， 在接受NOWS治疗的婴儿中使用吗啡将减少阿片类药物治疗的天数。使用最高 研究标准，我们将完成由美国国立卫生研究院提出的任务，以缩小在这方面的研究差距， 重要领域。 1 2