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。 NOWS 的急剧上升与孕妇使用阿片类药物的增加有关 女性。对于识别、监测和治疗受影响的最佳方法知之甚少 婴儿。 IDeA 国家儿科临床试验网络 (ISPCTN)，是环境研究中心的一部分 对儿童健康结果 (ECHO) 计划和新生儿研究网络 (NRN) 的影响 独特地解决了与NOWS 相关的现有知识差距。 ISPCTN 由超过 20 个 新生儿重症监护病房和 NRN 由超过 50 个新生儿重症监护病房组成。两个网络 可以接触临床试验的研究者、研究协调员、基础设施和参与者。这 杜克临床研究所 (DCRI) 作为 ECHO 协调中心，拥有广泛的研究成果 具有婴儿队列研究和临床试验的经验。我们提案的总体目标是使用 ECHO 计划和 ISPCTN 的基础设施与 NRN 合作启动了两项临床 评估干预措施的试验，以改善受NOWS 影响的婴儿和家庭的护理。我们的 由 DCRI 的 Brian Smith 博士领导的研究团队将通过实施以下措施来实现这一目标：1) 临床试验 评估饮食、睡眠、安慰 (ESC) 护理方法对时长的最佳使用的协议 受NOWS 影响的婴儿在医疗上做好出院准备的时间； 2) 临床试验方案 评估接受 NOWS 治疗的婴儿早期停止吗啡断奶方案是否有效 减少阿片类药物治疗的天数。我们将采用最高的研究标准 完成 NIH 设定的任务，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.

• 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