Impact of Neonatal Heart Rate Characteristics Monitoring

新生儿心率特征监测的影响

• 批准号: 7097473
• 负责人: JOSEPH RANDALL MOORMAN
• 金额: $ 49.49万
• 依托单位: UNIVERSITY OF VIRGINIA
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-07-20 至 2010-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7097473
• 关键词: antibiotics; clinical research; clinical trials; disease /disorder proneness /risk; early diagnosis; heart disorder diagnosis; heart rate; hospital length of stay; human subject; infant mortality; low birth weight infant human; neonatal intensive care; patient monitoring device; patient oriented research; premature infant human; respirators; septicemia; statistics /biometry

DESCRIPTION (provided by applicant): Neonatal sepsis is a major cause of morbidity and mortality. The long term goal of this research is to improve outcomes of premature infants at risk of sepsis. The approach is based on the finding that clinical findings of neonatal sepsis are preceded by abnormal heart rate characteristics (HRC) of reduced variability and transient decelerations. Prior studies have led to a predictive algorithm for sepsis using continuous HRC monitoring that was developed at 1 center, and both internally and externally validated. Thus HRC monitoring is a potential adjunct to clinical care of premature infants that may improve their outcomes by allowing early diagnosis of neonatal sepsis. The Aim of this proposal is to test the hypothesis that HRC monitoring improves outcomes in NICU patients. The study design is a randomized clinical trial in which monitoring results are available for half the infants in 3 university tertiary care neonatal intensive care units. The main study group is very low birth weight infants, and the main outcome variable is ventilator-free days during the first 120 days of life. Secondary endpoints are length of stay, antibiotic usage, and in-hospital mortality, and we will study the supergroup of all NICU admissions. The site PIs are the division heads, and each has extensive experience in clinical trials. The project PI made the original observation of abnormal HRC prior to clinical signs of neonatal sepsis, and developed the validated clinical predictive tool. The Clinical Trials Office of the University of Virginia will provide secure and confidential data management. There is expert mathematical and biostatistical analysis. We feel that there is no more important problem in clinical neonatology, and that this approach represents a truly novel method to assist clinical neonatologists in early diagnosis of sepsis.

描述（由申请人提供）：新生儿败血症是发病率和死亡率的主要原因。这项研究的长期目标是改善有脓毒症风险的早产儿的预后。该方法是基于发现新生儿败血症的临床表现是由异常心率特征（HRC）变异性降低和短暂减速。先前的研究已经产生了一种预测败血症的算法，该算法使用连续HRC监测，在一个中心开发，并得到了内部和外部的验证。因此，HRC监测是早产儿临床护理的潜在辅助手段，可以通过早期诊断新生儿败血症来改善早产儿的预后。本建议的目的是验证HRC监测改善新生儿重症监护病房患者预后的假设。研究设计是一项随机临床试验，其中监测结果可用于3所大学三级新生儿重症监护病房的一半婴儿。主要研究组为极低出生体重儿，主要结局变量为出生后120天无呼吸机天数。次要终点是住院时间、抗生素使用和住院死亡率，我们将研究所有新生儿重症监护病房入院的超组。现场pi是部门负责人，每个人都有丰富的临床试验经验。项目PI对新生儿脓毒症临床症状出现前的HRC异常进行了原始观察，并开发了经过验证的临床预测工具。弗吉尼亚大学临床试验办公室将提供安全和保密的数据管理。有专业的数学和生物统计分析。我们认为在临床新生儿学中没有比这更重要的问题了，这种方法代表了一种真正新颖的方法来帮助临床新生儿医生早期诊断败血症。