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: 10873579
• 负责人: Laura Kristin NEWBY
• 金额: $ 99.98万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10873579
• 关键词: Address; Administrative Supplement; Affect; Area; Arkansas; Caring; Child Health; Childhood; Clinical; Clinical Research; Clinical Trials; Clinical Trials Network; Cohort Studies; Collaborations; Consent; Data; Data Coordinating Center; Eating; Enrollment; Examinations and Diagnoses; 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; Pregnant Women; Principal Investigator; Protocols documentation; Qualifying; Randomized; Randomized, Controlled Trials; Reflex action; Research; Research Design; Research Institute; Research Personnel; Resources; Science; Seizures; Site; Sleep; Time; United States National Institutes of Health; Universities; Weaning; Weight Gain; clinical trial participant; clinical trial protocol; design; experience; improved; operation; prenatal exposure; primary outcome; programs; sucking; treatment and outcome; 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. 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 Dr. Brian Smith at DCRI, 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.

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。的 NOWS的急剧上升与孕妇使用阿片类药物的增加有关， 妇女对受影响的患者的识别、监测和治疗的最佳方法知之甚少。 婴儿。IDEA国家儿科临床试验网络（ISPCTN），这是环境的一部分， 对儿童健康结果（ECHO）计划和新生儿研究网络（NRN）的影响， 特别是准备解决与NOWS相关的现有知识差距。ISPCTN由> 20个 新生儿重症监护病房和NRN包括> 50新生儿重症监护病房。两个网络 接触研究者、研究协调员、基础设施和临床试验参与者。的 杜克临床研究所（DCRI）作为ECHO协调中心， 婴儿队列研究和临床试验经验。我们建议的总体目标是利用 ECHO计划和ISPCTN的基础设施与NRN合作， 评估干预措施以改善受NOWS影响的婴儿和家庭的护理的试验。我们 由DCRI的Brian Smith博士领导的研究小组将通过以下方式实现这一目标：1）临床试验 评估进食、睡眠、安慰（ESC）护理方法在持续时间上的最佳使用的方案 受NOWS影响的婴儿在医疗上准备出院的时间;以及2）临床试验方案 评估在接受NOWS治疗的婴儿中早期停止吗啡断奶方案是否会 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NIH提出的任务，以缩小这一至关重要领域的研究差距。

项目成果

Pragmatic, randomized, blinded trial to shorten pharmacologic treatment of newborns with neonatal opioid withdrawal syndrome (NOWS).

• DOI: 10.1186/s13063-023-07378-x
• 发表时间: 2023-07-21
• 期刊: Trials
• 影响因子: 2.5

Cognitive and motor function in adults with spina bifida myelomeningocele: a pilot study.

脊柱脊虫脊髓脑纤维膨出的成年人的认知和运动功能：一项初步研究。

• DOI: 10.1007/s00381-020-04964-1
• 发表时间: 2021-04
• 期刊: Child's nervous system : ChNS : official journal of the International Society for Pediatric Neurosurgery
• 作者: Jasien JM;Mikati MA;Kolarova M;Smith B;Thera S;Lee P
• 通讯作者: Lee P