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Impact of Neonatal Heart Rate Characteristics Monitoring

新生儿心率特征监测的影响

基本信息

批准号：
7666829
负责人：
JOSEPH RANDALL MOORMAN
金额：
$ 50.25万
依托单位：
UNIVERSITY OF VIRGINIA
依托单位国家：
美国
项目类别：
财政年份：
2005
资助国家：
美国
起止时间：
2005-07-20 至 2011-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7666829
关键词：
Acute Admission activity Algorithms Antibiotics CD 200 Caring Catastrophic Illness Cessation of life Characteristics Clinical Clinical Data Clinical Trials Complication Databases Deceleration Diagnosis Early Diagnosis Goals Head Heart Rate Hospital Mortality Hospitalization Infant Infection Length of Stay Life Measures Mechanical ventilation Medical Methods Monitor Morbidity - disease rate National Institute of Child Health and Human Development Neonatal Neonatal Intensive Care Units Neonatology Outcome Patients Physicians Premature Infant Randomized Clinical Trials Research Research Design Research Personnel Risk Secure Sepsis Site System Testing Time Training Universities Urinary tract infection Ventilator Very Low Birth Weight Infant Virginia base clinical care cost data management experience improved mathematical model member mortality neonatal sepsis novel programs social successful intervention tertiary care tool

项目摘要

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败血症风险的早产儿的结局。这一方法是基于这样一个发现，即新生儿败血症的临床表现之前会出现变异性降低和一过性减速的异常心率特征(HRC)。先前的研究已经导致了一种使用持续的HRC监测的脓毒症预测算法，该算法是在1个中心开发的，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他们的预后。这项建议的目的是检验人权委员会监测改善NICU患者预后的假设。这项研究设计是一项随机临床试验，其中对3所大学三级新生儿重症监护病房中一半的婴儿进行了监测。主要的研究组是极低出生体重儿，主要的结局变量是生命的前120天内无呼吸机的天数。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NICU入院人数的超级组。现场PI是部门负责人，每个人都有丰富的临床试验经验。PI项目在新生儿败血症临床体征出现前对HRC值的异常进行了初步观察，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，可以帮助临床新生儿医生早期诊断败血症。

项目成果

期刊论文数量（7）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Heart rate characteristics: physiomarkers for detection of late-onset neonatal sepsis.

DOI：
10.1016/j.clp.2010.06.002
发表时间：
2010-09
期刊：
Clinics in perinatology
影响因子：
2.1
作者：
Fairchild KD;O'Shea TM
通讯作者：
O'Shea TM

Trajectories of the heart rate characteristics index, a physiomarker of sepsis in premature infants, predict Neonatal ICU mortality.

DOI：
10.1177/2048004020945142
发表时间：
2020-01
期刊：
JRSM cardiovascular disease
影响因子：
1.6
作者：
Zimmet AM;Sullivan BA;Moorman JR;Lake DE;Ratcliffe SJ
通讯作者：
Ratcliffe SJ

Meningitis, urinary tract, and bloodstream infections in very low birth weight infants enrolled in a heart rate characteristics monitoring trial.

DOI：
10.1038/s41390-019-0701-4
发表时间：
2020-06-01
期刊：
Pediatric research
影响因子：
3.6
作者：
Weitkamp, Joern-Hendrik;Aschner, Judy L;Fairchild, Karen D
通讯作者：
Fairchild, Karen D

Mortality reduction by heart rate characteristic monitoring in very low birth weight neonates: a randomized trial.

DOI：
10.1016/j.jpeds.2011.06.044
发表时间：
2011-12
期刊：
JOURNAL OF PEDIATRICS
影响因子：
5.1
作者：
Moorman, Joseph Randall;Carlo, Waldemar A.;Kattwinkel, John;Schelonka, Robert L.;Porcelli, Peter J.;Navarrete, Christina T.;Bancalari, Eduardo;Aschner, Judy L.;Walker, Marshall Whit;Perez, Jose A.;Palmer, Charles;Stukenborg, George J.;Lake, Douglas E.;O'Shea, Thomas Michael
通讯作者：
O'Shea, Thomas Michael

Abnormal heart rate characteristics before clinical diagnosis of necrotizing enterocolitis.

DOI：
10.1038/jp.2013.63
发表时间：
2013-11
期刊：
JOURNAL OF PERINATOLOGY
影响因子：
2.9
作者：
Stone, M. L.;Tatum, P. M.;Weitkamp, J-H;Mukherjee, A. B.;Attridge, J.;McGahren, E. D.;Rodgers, B. M.;lake, D. E.;Moorman, J. R.;Fairchild, K. D.
通讯作者：
Fairchild, K. D.