COLLABORATIVE HOME INFANT MONITORING EVALUATION (CHIME)

描述（改编自申请人的描述）：这是一份申请 作为临床试验运营中心继续参与 扩展协作家庭婴儿监测评估 (CHIME) 研究结束 未来五年。 每年约有 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 对于婴儿猝死风险较高的三组之一的婴儿 综合症 (SIDS)：出现特发性明显症状的婴儿 危及生命的事件（婴儿期呼吸暂停，AO1）、SIDS 兄弟姐妹和早产 婴儿。 尽管有多年的经验，但尚不清楚其程度如何 监护仪的使用降低了婴儿发病率或死亡率。 钟声 该研究旨在解决有关谁拥有 CR 的未解决问题 家里发生的事件、这些事件的性质及其对 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。 一个 总共 2,115 名婴儿将被纳入其中：375 名健康足月婴儿，330 名 SIDS 兄弟姐妹，330 名 AO1 患者，以及 1,080 名出生体重 < 1750 克的早产儿。 每个婴儿将接受隔夜多声波检查，并在以下时间接受监测： 使用为 CHIME 研究开发的记忆监测器在家观察 4-5 个月。 监视器将存储家里发生的所有 CR 事件以及相关的事件 血氧饱和度和睡眠姿势，将记录周期性非事件 （标准）间隔，并将连续记录 R-R 和呼吸间呼吸 间隔。 呼吸暂停可分为中枢性呼吸暂停、混合性呼吸暂停或阻塞性呼吸暂停 使用电感体积描记法，这是一种以前不可用的技术 用于家庭监控。 临床和神经发育状态将 纵向确定至 1 岁。 CHIME 研究将 对发生在以下地区的所有 CR 事件进行全面总结 家。 结果将产生有关潜在问题的重要见解 机制、预测事件的先行变量、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.