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新生儿脐静脉血血常规、PCT、CRP对有感染高危因素新生儿早发败血症的预测价值
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注册号:

Registration number:

ChiCTR2000039751 

最近更新日期:

Date of Last Refreshed on:

2020-11-08 

注册时间:

Date of Registration:

2020-11-08 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

新生儿脐静脉血血常规、PCT、CRP对有感染高危因素新生儿早发败血症的预测价值 

Public title:

The value of umbilical venous blood routine, PCT and CRP in predicting early-onset sepsis of neonates with high risk factors of infection  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

脐血PCT、CRP对有感染高危因素新生儿早发感染的诊断价值研究 

Scientific title:

The value of umbilical cord blood PCT and CRP in the diagnosis of early-onset sepsis in newborns with high risk factors of infection 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

陈翠娥 

研究负责人:

陈淑君 

Applicant:

Cuie Chen 

Study leader:

Shujun Chen 

申请注册联系人电话:

Applicant telephone:

13777908806 

研究负责人电话:

Study leader's telephone:

13575939201 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

chencuie123456@163.com 

研究负责人电子邮件:

Study leader's E-mail:

cce1377@163.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

中国浙江省义乌市新科路C100号 

研究负责人通讯地址:

中国浙江省义乌市新科路C100号 

Applicant address:

No. C100 Xinke Road, Yiwu, Zhejiang, China 

Study leader's address:

No. C100 Xinke Road, Yiwu, Zhejiang, China 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

义乌市妇幼保健院 

Applicant's institution:

Yiwu Maternity and Children Hospital 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

0000033 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

义乌市妇幼保健院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Yiwu Maternity and Children Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-15 

伦理委员会联系人:

吴丽丽 

Contact Name of the ethic committee:

Lili Wu 

伦理委员会联系地址:

中国浙江省义乌市新科路C100号 

Contact Address of the ethic committee:

No. C100 Xinke Road, Yiwu, Zhejiang, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

义乌市妇幼保健院 

Primary sponsor:

Yiwu Maternity and Children Hospital 

研究实施负责(组长)单位地址:

中国浙江省义乌市新科路C100号 

Primary sponsor's address:

No. C100 Xinke Road, Yiwu, Zhejiang, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

浙江

市(区县):

Country:

China

Province:

Zhejiang

City:

单位(医院):

义乌市妇幼保健院

具体地址:

中国浙江省义乌市新科路C100号

Institution
hospital:

Yiwu Maternity and Children Hospital

Address:

No. C100 Xinke Road, Yiwu, Zhejiang, China

经费或物资来源:

义乌市妇幼保健院 

Source(s) of funding:

Yiwu Maternity and Children Hospital 

研究疾病:

新生儿早发感染 

Target disease:

early-onset sepsis in newborns  

研究疾病代码:

 

Target disease code:

 

研究类型:

诊断试验 

Study type:

Diagnostic test 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

本研究通过检测有感染高危因素新生儿脐血血常规、PCT、CRP水平,明确PCT、CRP、中性粒/淋巴细胞比值(neutrophil-to-lymphocyte ratio, NLR)对新生儿早发感染的诊断价值。 

Objectives of Study:

To explore the predictive value of cord blood PCT CRP and neutrophil-to-lymphocyte ratio (NLR) for Early-onset sepsis (EOS) in newborns. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

横断面 

Study design:

Cross-sectional 

纳入标准:

2020年12月-2021年12月在本院定期产检、分娩,母亲无重大内外科疾病,有感染高危因素的新生儿。感染高危因素指符合以下任一条件者:(1)胎膜早破>18h;(2)母亲妊娠晚期发热或血PCT、CRP、WBC指标升高;(3)羊水Ⅲ度污染或臭味;(4)绒毛膜羊膜炎;(5)孕34周阴道GBS 培养阳性;(6)胎儿宫内窘迫或新生儿出生窒息史;(7)胎盘早剥;(8)胎龄小于33周。 

Inclusion criteria

Newborns who delivered in our hospital from December 2020 to December 2021, whose mothers have no major internal or surgical diseases and have high risk factors for infection. Risk factors of infection refer to those who meet any of the following conditions:(1) premature rupture of membranes with > for 18h; (2) Maternal fever in the third trimester of pregnancy or increased blood PCT, CRP and WBC;(3) the amniotic fluid Ⅲ pollution or odor;(4) chorioamnionitis;(5) Positive vaginal GBS culture at 34 weeks of pregnancy;(6) History of fetal distress or neonatal asphyxia;(7) Placental abruption; (8) Gestational age less than 33 weeks. 

排除标准:

先天严重畸形、遗传代谢性疾病、染色体疾病、因各种原因未能按研究程序完成研究者。 

Exclusion criteria:

Severe congenital malformation, genetic metabolic diseases, chromosomal diseases, and failure to complete the study procedures for various reasons. 

研究实施时间:

Study execute time:

From2020-12-01To 2021-12-31 

征募观察对象时间:

Recruiting time:

From2020-12-01To 2021-12-31 

诊断试验:

Diagnostic Tests:

金标准或参考标准(即可准确诊断某疾病的单项方法或多项联合方法,在本研究中用于诊断是否有该病的临床参考标准):

根据新生儿败血症诊断及治疗专家共识(2019年版):新生儿早发感染指生后72小时内发生的感染,包括:(1)存在临床感染症状并且血培养等培养阳性;(2)存在3项及3项以上临床感染症状或者1项及1项以上临床感染症状合并血液感染依据(血小板<100×109/L,白细胞<5×109/L或>20×109/L,CRP>5mg/L)或影像支持感染,可临床诊断感染;临床感染症状包括(a)呼吸系统症状:呼吸暂停,呼吸急促(呼吸频率>60次/分),三凹征,发绀,呼吸窘迫)。(b)消化系统症状:腹胀,血便。(c)心血管系统症状:心动过缓(心率<100次/分),心动过快(心率>180次/分),低血压。(d)神经系统症状:易激惹,嗜睡,抽搐。(e)体温不稳定:肛温<36.0℃ 或 >38.0℃。(f)末梢循环不良或毛细血管充盈时间>3秒。

Gold Standard or Reference Standard (The clinical reference standards required to establish the presence or absence of the target condition in the tested population in present study):

According to the expert consensus on the diagnosis and treatment of neonatal sepsis (2019 edition), neonatal early infection refers to the infection occurring within 72 hours after birth, including: (1) the presence of clinical symptoms of infection and positive cultures such as blood culture;(2) The presence of

指标试验(即本研究的待评估诊断试验,无论为方法、生物标志物或设备,均请列出名称):

血培养、血小板、白细胞、临床感染症状

Index test:

Blood culture, platelets, leukocytes, clinical symptoms of infection

目标人群(可以是某种疾病患者或正常人群,详细描述其疾病特征,注意应纳入符合分布特点的全序列病例,具有良好的代表性)

具有感染高危因素新生儿,符合以下任一条件者:(1)胎膜早破>18h;(2)母亲妊娠晚期发热或血PCT、CRP、WBC指标升高;(3)羊水Ⅲ度污染或臭味;(4)绒毛膜羊膜炎;(5)阴道分泌物培养阳性;(6)胎儿宫内窘迫或新生儿出生窒息史;(7)胎龄小于33周。

例数:

Sample size:

300

Target condition (The target condition is a particular disease or disease stage that the index test will be intended to identify. Please specify the characteristics in detail; the population should has a complete spectrum and good representative):

Newborns with high risk of infection,If any of the following conditions are met:(1) premature rupture of membrane > for 18h;(2) Maternal fever in the third trimester of pregnancy or increased blood PCT, CRP and WBC;(3) of the amniotic fluid Ⅲ pollution or odor;(4) Chorionic amnitis;(5) Positive vaginal secretio

容易混淆的疾病人群(即与目标疾病不易区分的一种或多种不同疾病,应避免采用正常人群对照的病例-对照设计):

新生儿呼吸窘迫综合征、新生儿肺炎

例数:

Sample size:

0

Population with condition difficult to distinguish from the target condition, the normal population in a case-control study design should be avoid:

Neonatal respiratory distress syndrome、Neonatal pneumonia

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

义乌市妇幼保健院 

单位级别:

三级乙等医院 

Institution
hospital:

Yiwu Maternity and Children Hospital  

Level of the institution:

Tertiary Level B hospital 

测量指标:

Outcomes:

指标中文名:

早发感染

指标类型:

主要指标 

Outcome:

early-onset sepsis

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血培养

指标类型:

主要指标 

Outcome:

blood culture

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血常规

指标类型:

主要指标 

Outcome:

blood routine

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

临床感染症状

指标类型:

主要指标 

Outcome:

Clinical symptoms of infection

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

脐带静脉血

组织:

Sample Name:

Cord venous blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 0 years
最大 Max age 0 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

不是随机

Randomization Procedure (please state who generates the random number sequence and by what method):

not Randomization

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

chencuie123456@163.com

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

chencuie123456@163.com

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

病例记录表

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

A standard data collection and management system include a CRF and an electronic data capture

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-11-08
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