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: 10505279
• 负责人: JOHN D BARKS
• 金额: $ 38.74万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10505279
• 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.

抽象的 在美国出生的十个孩子中，大约有一个被接纳为新生儿重症监护室 （NICU）。睡眠对于健康发展至关重要，研究人员正在研究如何改善睡眠。 NICU睡眠良好的一个主要障碍是婴儿经常会受到中断。调整这些 基于婴儿是否睡着的中断，哪种睡眠状态可以改善睡眠，从而可以改善睡眠 改善健康的发展。但是，通常不可能分辨出NICU中的婴儿是清醒的还是 睡着了，因为这些年轻人的行为曲目非常有限，并且可能会进一步受到其他人的影响 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 睡在新生儿。这是开发可以实时提供技术的迫切需求 评估新生儿是清醒还是入睡，以及睡眠阶段。总体目标 建议是通过为新生儿新生儿的睡眠效果阶段创建实时监视器来解决，该建议需要创建。 该项目还将收集有关设备实用程序的初步数据。这些数据包括比较 在婴儿被醒来的饲料与已经清醒的情况下的病例之间的喂养效率， 睡眠中断和与接受药物有关的睡眠变化。该项目受益于两个 首席研究人员，是新生儿临床实践和研究专家，另一个是数据科学家 具有开发长期临床神经监测算法的经验。在R61阶段的具体目标 该奖项包括1）开发工作原型并进行初始测试和验证以及2） 获得初始用例和前市场数据。该奖项的R33阶段允许进行预期验证 和验证。直接的预期结果是经过验证的，经过验证的设备和初步用例 数据，允许该建议直接进行有关实践如何变化的临床研究 基于对睡眠的实时知识，可以改善NICU的护理。预期的，长期的结果将是 将研究转化为临床实践的商业设备。