COLLABORATIVE HOME INFANT MONITORING EVALUATION (CHIME)

描述（改编自申请人的描述）：这是一个应用程序 作为临床试验运营中心继续参与 协作式家庭婴儿监护评估（CHIME）研究 未来五年 每年大约有5万名婴儿被安置在 家用心肺（CR）监护仪。 通常规定 对于婴儿猝死风险增加的三组之一的婴儿， 综合征（SIDS）：发生特发性明显 危及生命的事件（婴儿期呼吸暂停，AO 1）、SIDS兄弟姐妹和早产儿 婴儿。 尽管有多年的经验， 监测器的使用降低了婴儿发病率或死亡率。 编钟 研究旨在解决关于CR患者的未解决问题 国内发生的事件，这些事件的性质，以及它们对 神经发育结果。 我们建议将CHIME延长5年 研究，以完成入组、随访和数据分析。 一 共入组2，115名婴儿：375名健康足月婴儿，330名SIDS 330例AO 1患者和1，080例出生体重< 1750 g的早产儿。 每名婴儿将接受一次夜间多道超声检查， 使用为CHIME研究开发的记忆监测器在家4-5个月。 监护仪将存储在家中发生的所有CR事件以及相关 氧饱和度和睡眠位置，将记录周期性的非事件 （标准）间隔，并将连续记录R-R和呼吸到呼吸 的间隔 呼吸暂停将被分类为中枢性、混合性或阻塞性， 使用电感体积描记法，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 在1岁时纵向确定。 CHIME研究将 创建发生的全系列CR事件的全面总结， 家中 结果将产生重要的见解， 机制，预测事件的前因变量，适当的 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.