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.

抽象的 在美国出生的儿童中大约有十分之一被送入新生儿重症监护室 （新生儿重症监护病房）。睡眠对于健康发育至关重要，研究人员正在研究如何改善睡眠。 新生儿重症监护病房 (NICU) 良好睡眠的一大障碍是婴儿经常受到干扰。 根据婴儿是否睡着以及什么睡眠状态可以改善睡眠来进行干扰，从而 改善健康发育 然而，通常无法判断 NICU 中的婴儿是否清醒或是否清醒。 睡着了，因为这些孩子的行为能力非常有限，并且可能会进一步受到其他因素的影响 此外，很少有中心拥有评估和分析的设备和临床专业知识。 因此，迫切需要开发能够提供实时睡眠的技术。 评估新生儿是否清醒或睡眠，以及睡眠阶段的总体目标。 建议通过为 NICU 中的新生儿创建睡眠-觉醒阶段的实时监测器来满足这一需求。 该项目还将收集有关该设备实用性的初步数据，其中包括比较。 婴儿醒着喂奶与已经醒着喂奶的情况之间的喂养效果， 睡眠中断和与所接受药物相关的睡眠变化该项目受益于两个。 主要研究者，其中一名是新生儿临床实践和研究专家，另一名是数据科学家 开发 R61 阶段长期临床神经监测的经验算法。 该奖项包括 1) 开发工作原型并进行初步测试和验证，以及 2) 获取初始用例和上市前数据可以在 R33 阶段进行前瞻性验证。 直接的预期结果是经过验证、验证的设备和初步用例。 数据，使该提案可以直接进行有关实践如何变化的临床研究 基于实时睡眠知识可以改善 NICU 的护理效果。 一种商业设备，可以将研究转化为临床实践。