Real-time state of vigilance monitor for the neonatal intensive care unit

新生儿重症监护病房实时警戒状态监测

• 批准号: 10053394
• 负责人: JOHN D BARKS
• 金额: $ 38.04万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-01 至 2022-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10053394
• 关键词: Address; Age; Algorithmic Software; Algorithms; Award; Behavioral; Bottle feeding; Caffeine; Caring; Child; Clinical; Clinical Research; Clinical Trials; Cues; Custom; Data; Data Analyses; Data Scientist; Development; Devices; Dose; Electroencephalography; Equipment; Event; Feeds; Frequencies; Funding; Goals; Health; Health Professional; Health Services Accessibility; Improve Access; Industry; Infant; Infant Health; Intensive Care; Interruption; Intervention; Intervention Studies; Interview; Knowledge; Lead; Liquid substance; Manuals; Measures; Medicine; Methadone; Middle Insomnia; Monitor; Neonatal; Neonatal Intensive Care Units; Neurology; Newborn Infant; Outcome; Performance; Pharmaceutical Preparations; Phase; Polysomnography; Principal Investigator; Prospective cohort; Publishing; Research; Research Personnel; Scientist; Secure; Sleep; Sleep Fragmentations; Sleep Stages; Sleep disturbances; Standardization; Technology; Testing; Time; Translating; Translational Research; Translations; United States; Work; algorithm development; awake; base; care delivery; clinical care; clinical practice; data acquisition; data quality; design; experience; feeding; healing; improved; interest; neonate; neurodevelopment; premature; prevent; programs; prospective; prototype; real time monitoring; respiratory; sleep quantity; tool; verification and validation; vigilance

Abstract Approximately one out of ten children born in the United States are admitted to the neonatal intensive care unit (NICU). Sleep is essential to healthy development, and researchers are investigating how to improve sleep. One major barrier to good sleep in the NICU is the frequent interruptions the infants receive. Adjusting these interruptions based on whether the infant is asleep and what state of sleep could improve sleep and thus improve healthy development. However, it is generally not possible to tell if an infant in the NICU is awake or asleep, as the behavioral repertoire is very limited as these young ages and may be further influenced by other health conditions. Furthermore, few centers have the equipment and clinical expertise to assess and analyze sleep in neonates. Thus, there is a critical need to develop technology which could provide real-time assessment of whether neonates are awake or asleep, as well as the stage of sleep. The overall goal of this proposal is to address that need by creating a real-time monitor of sleep-wake stage for neonates in the NICU. The project will additionally gather preliminary data about the device’s utility. These data include comparing feeding efficacy between cases where the infant is awoken to feed versus already being awake, influence of interruptions to sleep, and sleep changes related to medications received. This project benefits from two principal investigators, one an expert in neonatal clinical practice and research and the other a data scientist with experience developing algorithms for long term clinical neuromonitoring. Specific Aims in the R61 phase of the award include 1) developing a working prototype and conducting initial testing and verification and 2) acquiring initial use-case and pre-market data. The R33 phase of the award allows for prospective validation and verification. The immediate, expected outcome is the verified, validated device and preliminary use-case data, allowing this proposal to be directly followed by clinical research regarding how changes in practice based on real-time knowledge of sleep can improve care in the NICU. The expected, long term outcome will be a commercial device allowing translation of that research into clinical practice.

摘要 在美国出生的儿童中，大约十分之一被送入新生儿重症监护室 （新生儿重症监护病房）。睡眠对健康发育至关重要，研究人员正在研究如何改善睡眠。 NICU中良好睡眠的一个主要障碍是婴儿经常受到干扰。调整这些 根据婴儿是否睡着以及睡眠状态可以改善睡眠， 促进健康发展。然而，通常不可能判断NICU中的婴儿是否清醒， 睡眠，因为这些年轻人的行为能力非常有限，可能会受到其他因素的进一步影响。 健康状况。此外，很少有中心拥有设备和临床专业知识来评估和分析 新生儿睡眠因此，迫切需要开发能够提供实时通信的技术。 评估新生儿是醒着还是睡着，以及睡眠阶段。总的目标是 建议是通过为NICU中新生儿创建睡眠-觉醒阶段实时监测器来解决该需求。 该项目还将收集有关该设备实用性的初步数据。这些数据包括比较 婴儿被唤醒进食与已经醒来进食的情况之间的喂养功效， 睡眠中断，以及与接受的药物有关的睡眠变化。该项目得益于两个 主要研究者，一位是新生儿临床实践和研究专家，另一位是数据科学家 具有开发长期临床神经监测算法的经验。R61阶段的具体目标 该奖项包括1）开发一个工作原型，并进行初步测试和验证，2） 获取初始用例和上市前数据。该奖项的R33阶段允许前瞻性验证 和核查。直接的预期结果是经过验证、确认的设备和初步用例 数据，使这一建议直接遵循临床研究如何改变实践 基于睡眠的实时知识可以改善NICU的护理。预期的长期结果将是 一种商业设备，可以将该研究转化为临床实践。