Heart Rate Characteristics Monitoring in Newborn Infant

描述(申请人提供)：败血症是新生儿重症监护病房(NICU)中高危新生儿的主要健康问题，25%的极低出生体重儿会发生败血症，导致死亡率增加一倍以上，住院时间增加50%。异常心率特征(HRC)变异性降低和一过性减速发生在新生儿败血症的早期，一个中心已经开发了预测脓毒症和死亡的多变量模型，并在另一个中心进行了验证。我们的长期目标是验证这样一种假设，即持续的HRC监测将通过早期诊断脓毒症和其他亚急性、潜在灾难性疾病来改善这些患者的护理。我们建议通过完成三个研究目标来实现这一目标。 在目标1中，我们将检验这一假设，即结合传统的实验室测试和临床结果与HRC将导致改进的预测模型，以早期诊断迟发性新生儿败血症。在目标2中，我们将确定特定机制的测试和发现，并测试它们在迟发性新生儿败血症预测模型中添加信息的假设。这些目标的临床研究设计是从一组患者中推导出多变量预测统计模型，然后使用第二组患者的临床数据进行验证阶段。在目标3中，我们将开发新的数学指标，在迟发性新生儿败血症过程中早期发现HRC异常，特别是减速特征的指标。 我们认为NICU中的HRC监测是一种真正新颖的方法，我们打算在开发临床用于新生儿败血症早期诊断的预测算法方面处于领先地位。

DESCRIPTION (provided by applicant): Sepsis is a major health problem in high-risk newborn infants in the neonatal intensive care unit (NICU), where it occurs in 25 percent of very low birth weight infants and leads to a more than doubling of mortality and a 50 percent increase in hospital stay. Abnormal heart rate characteristics (HRC) of reduced variability and transient decelerations occur early in the course of neonatal sepsis, and predictive multivariable models for sepsis and death have been developed at one center and validated at another. Our long-term goal is to test the hypothesis that continuous HRC monitoring will improve care of these patients by earlier diagnosis of sepsis and other sub-acute, potentially catastrophic illnesses. We propose to advance toward this objective by completing three research aims. In Aim 1, we will test the hypothesis that incorporating conventional lab tests and clinical findings with HRC will lead to improved predictive models for early diagnosis of late-onset neonatal sepsis. In Aim 2, we will identify mechanism-specific tests and findings, and test the hypothesis that they add information in predictive models of late-onset neonatal sepsis. The clinical research design for these Aims is a derivation of multivariable predictive statistical models from one set of patients followed by a validation phase using clinical data from a second set of patients. In Aim 3, we will develop new mathematical measures that detect abnormal HRC early in the course of late-onset neonatal sepsis, in particular, measures of deceleration characteristics. We feel that HRC monitoring in the NICU is a truly novel approach, and we intend to lead the field in developing predictive algorithms for clinical use in the early diagnosis of neonatal sepsis.