COLLABORATIVE HOME INFANT MONITORING EVALUATION (CHIME)

协作家庭婴儿监测评估 (CHIME)

• 批准号: 2836779
• 负责人: MICHAEL R NEUMAN
• 金额: $ 24.96万
• 依托单位: UNIVERSITY OF MEMPHIS
• 依托单位国家: 美国
• 财政年份: 1996
• 资助国家: 美国
• 起止时间: 1996-09-30 至 2000-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2836779
• 关键词: apnea; clinical research; clinical trials; cooperative study; disease /disorder proneness /risk; home health care; human subject; human therapy evaluation; infant human (0-1 year); mother /infant health care; patient monitoring device; plethysmography; premature infant human; respirators; sleep apnea; sudden infant death syndrome

DESCRIPTION (Adapted from applicant's description): This is an application for continued participation as the Clinical Trials Operations Center in an extended Collaborative Home Infant Monitoring Evaluation (CHIME) Study over the next five years. Each year, approximately 50,000 infants are placed on a home cardiorespiratory (CR) monitor. Monitors are typically prescribed for infants in one of three groups at increased risk for Sudden Infant Death Syndrome (SIDS): infants who experience an idiopathic apparent life-threaten-ing event (apnea of infancy, AO1), SIDS siblings, and preterm infants. Despite years of experience, it is not known to what extent monitor use has reduced either infant morbidity or mortality. The CHIME study is designed to address the unresolved questions regarding who has CR events at home, the nature of these events, and their impact on neurodevelopmental outcome. We propose a 5-year extension of the CHIME study in order to complete enrollment, follow-up, and data analysis. A total of 2,115 infants will be enrolled: 375 healthy term infants, 330 SIDS siblings, 330 with AO1, and 1,080 preterm infants < 1750 g birth weight. Each infant will receive an overnight polyson-ogram and will be monitored at home for 4-5 months using a memory monitor developed for the CHIME study. The monitor will store all CR events occurring at home and the associated oxygen saturation and sleep position, will record periodic non-event (normative) intervals, and will continuously record R-R and breath-to-breath intervals. Apneas will be categorized as central, mixed or obstructive by the use of inductance plethysmography, a technique not previously available for home monitoring. Clinical and neurodevelopmental status will be ascertained longitudinally through 1 year of age. The CHIME study will create a comprehensive summary of the full range of CR events occurring in the home. The results will yield important insights regarding underlying mechanisms, antecedent variables predictive of events, appropriate intervention strategies, and the relationship between CR events and neurodevelopmental outcome.

描述（根据申请人的描述改编）：这是一个申请 作为临床试验操作中心的继续参与 扩展协作家庭婴儿监测评估（CHIME）研究 接下来的五年。 每年，约有50,000名婴儿 家庭心肺（CR）监测器。 监视器通常处方 对于三组中的婴儿，婴儿猝死风险增加 综合征（SIDS）：经历特发性明显的婴儿 威胁生命的事件（婴儿期，AO1），sids兄弟姐妹和早产 婴儿。 尽管经验了多年，但尚不清楚 监测率降低了婴儿的发病率或死亡率。 铃声 研究旨在解决有关谁有CR的未解决的问题 在家中的活动，这些事件的性质及其对 神经发育结果。 我们提出了5年的钟声延长 研究以完成入学，随访和数据分析。 一个 总共将招募2115名婴儿：375名健康的婴儿，330个SIDS 兄弟姐妹，330，带有AO1，1,080个早产儿<1750 g出生体重。 每个婴儿将收到一夜之间的Polyson-farm，并将在 使用用于Chime研究的内存监视器的内存监视器4-5个月。 监视器将存储所有发生在家里的CR事件以及相关的 氧饱和度和睡眠位置将记录周期性的非事件 （规范）间隔，并将不断记录R-R和呼吸呼吸 间隔。 apneas将被归类为中央，混合或阻塞性 使用电感多生理图，这是一种以前无法使用的技术 用于家庭监控。 临床和神经发育状态将是 纵向确定到1岁。 核研究将 创建一个全面的摘要，概述发生在 家。 结果将产生有关基础的重要见解 机制，预性变量可预测事件，适当 干预策略以及CR事件与 神经发育结果。