COLLABORATIVE HOME INFANT MONITORING EVALUATION (CHIME)

描述(根据申请者的描述改编)：这是一份申请 作为临床试验运营中心继续参与 扩展协作式家庭婴儿监测评估(CHME)研究结束 接下来的五年。每年，大约有50,000名婴儿被安置在 家用心肺(CR)监护仪。监视器通常是规定的 对于婴儿猝死风险增加的三组中的一组 综合征(SID)：出现特发性表观症状的婴儿 生命威胁事件(婴儿期呼吸暂停，AO1)、小岛屿发展中国家兄弟姐妹和早产儿 婴儿。尽管有多年的经验，但目前还不清楚在多大程度上 监视器的使用降低了婴儿发病率或死亡率。钟声 这项研究旨在解决关于谁患有CR的悬而未决的问题 国内事件、这些事件的性质及其对 神经发育结果。我们建议将编钟延长5年 研究以完成招生、跟踪、数据分析等工作。一个 总共2,115名婴儿将被登记：375名健康足月儿，330名小岛屿发展中国家 有330名AO1的兄弟姐妹，以及1080名早产儿和1750克出生体重。 每个婴儿都将接受通宵多导睡眠图检查，并将在 使用为CHINE研究开发的记忆监测器回家4-5个月。 监控器将存储在家中发生的所有CR事件以及关联的 血氧饱和度和睡眠姿势，将记录周期性的非事件 (规范)间隔，并将连续记录R-R和呼吸对呼吸 间隔时间。呼吸暂停分为中枢性、混合性或阻塞性。 电感体积描记术的使用，这是一种以前没有的技术 用于家庭监控。临床和神经发育状况将是 通过1岁的纵向确定。钟声研究将 创建发生在以下位置的所有CR事件的全面摘要 这个家。这些结果将产生关于潜在因素的重要见解 机制，预测事件的先行变量，适当 干预策略，以及CR事件与 神经发育结果。

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.