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: |
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English Acronym: |
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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: |
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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: |
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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): |
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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: |
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申请人所在单位: |
义乌市妇幼保健院 |
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Applicant's institution: |
Yiwu Maternity and Children Hospital |
是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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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 |
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Name of the ethic committee: |
Medical Ethics Committee of Yiwu Maternity and Children Hospital |
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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 |
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Contact Name of the ethic committee: |
Lili Wu |
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伦理委员会联系地址: |
中国浙江省义乌市新科路C100号 |
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Contact Address of the ethic committee: |
No. C100 Xinke Road, Yiwu, Zhejiang, China |
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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 |
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Primary sponsor: |
Yiwu Maternity and Children Hospital |
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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 |
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Primary sponsor's address: |
No. C100 Xinke Road, Yiwu, Zhejiang, China |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
义乌市妇幼保健院 |
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Source(s) of funding: |
Yiwu Maternity and Children Hospital |
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研究疾病: |
新生儿早发感染 |
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Target disease: |
early-onset sepsis in newborns |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
诊断试验 |
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Study type: |
Diagnostic test |
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研究所处阶段: |
其它 | ||||||||||||||||||||||
Study phase: |
N/A |
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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。 |
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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. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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研究设计: |
横断面 |
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Study design: |
Cross-sectional |
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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。 |
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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. |
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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。 |
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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: |
从From2020-12-01至To 2021-12-31 |
征募观察对象时间: Recruiting time: |
从From2020-12-01至To 2021-12-31 |
诊断试验: Diagnostic Tests: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
尚未开始 Not yet recruiting |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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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 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
not Randomization |
盲法: |
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Blinding: |
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试验完成后的统计结果(上传文件): |
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Calculated Results after
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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 |