ECHO Administrative Supplement - Neonatal Opioid Trials

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。戏剧性的崛起 NOWS的发生与孕妇使用阿片类药物的增加有关。小才是 了解识别、监测和治疗受影响婴儿的最佳方法。理念陈述 儿科临床试验网络(ISPCTN)，这是环境对儿童健康影响的一部分 成果(ECHO)计划和新生儿研究网络(NRN)是唯一准备解决的问题 与NOW相关的现有知识差距。ISPCTN由20个新生儿重症监护病房组成 NRN由50个新生儿重症监护病房组成。研究称，这两个网络都可以接触到调查人员 临床试验的协调者、基础设施和参与者。杜克临床研究所(DCRI) 作为ECHO协调中心，在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 ISPCTN在阿肯色大学医学科学(UAMS)。我们提案的总体目标是使用 ECHO计划的基础设施和ISPCTN与NRN合作启动两项临床试验 评估改善受NOWS影响的婴儿和家庭护理的干预措施。我们的研究团队，领导 DCRI的Brian Smith博士和Rachel Greenberg博士以及UAMS的Jeannette Lee博士和Jessica Snowden博士， 将通过实施：1)评估EAT的最佳使用的临床试验方案来实现该目标， 睡眠、安慰(ESC)护理方法关于受NOWS影响的婴儿在医学上得到治疗之前的时间长短 准备出院；以及2)临床试验方案，评估早期停止脱机方案是否适用于 治疗NOWS的婴儿使用吗啡会减少阿片类药物治疗的天数。使用最高的 研究标准，我们将完成美国国立卫生研究院提出的任务，以填补这方面的研究空白 重要的领域。 1 2.

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