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Database development and multicentral epidemiological study of the trauma among children of ICU in the mainland of China
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注册号:

Registration number:

ChiCTR2000031629 

最近更新日期:

Date of Last Refreshed on:

2020-04-05 

注册时间:

Date of Registration:

2020-04-05 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

中国大陆入住ICU儿童创伤数据库的研制及多中心流行病学研究  

Public title:

Database development and multicentral epidemiological study of the trauma among children of ICU in the mainland of China 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

中国大陆入住ICU儿童创伤数据库的研制及多中心流行病学研究  

Scientific title:

Database development and multicentral epidemiological study of the trauma among children of ICU in the mainland of China 

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:

胡蕾 

研究负责人:

谈林华 

Applicant:

Hu Lei 

Study leader:

Tan linhua 

申请注册联系人电话:

Applicant telephone:

+86 13805789873 

研究负责人电话:

Study leader's telephone:

+86 13858100149 

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:

zhiliao7988@163.com 

研究负责人电子邮件:

Study leader's E-mail:

chtlh@zju.edu.cn 

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:

浙江省杭州市滨江区滨盛路3333号 

研究负责人通讯地址:

浙江省杭州市滨江区滨盛路3333号 

Applicant address:

3333 Binsheng Road, Binjiang District, Hangzhou, Zhejiang, China 

Study leader's address:

3333 Binsheng Road, Binjiang District, Hangzhou, 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:

浙江大学医学院附属儿童医院 

Applicant's institution:

The Children's Hospital Zhejiang University School of Medicine 

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:

2020-IRB-009 

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:

浙江大学医学院附属儿童医院医学伦理委员会 

Name of the ethic committee:

ethics committee of children's Hospital Zhejiang University School of Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-01-23 

伦理委员会联系人:

马爱眉 

Contact Name of the ethic committee:

Ma Aimei 

伦理委员会联系地址:

浙江省杭州市滨江区滨盛路3333号 

Contact Address of the ethic committee:

3333 Binsheng Road, Binjiang District, Hangzhou, 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:

浙江大学医学院附属儿童医院 

Primary sponsor:

The Children's Hospital Zhejiang University School of Medicine 

研究实施负责(组长)单位地址:

浙江省杭州市滨江区滨盛路3333号 

Primary sponsor's address:

3333 Binsheng Road, Binjiang District, Hangzhou, 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):

浙江省

市(区县):

杭州市

Country:

China

Province:

Zhejiang

City:

Hangzhou

单位(医院):

浙江大学医学院附属儿童医院

具体地址:

浙江省杭州市滨江区滨盛路3333号

Institution
hospital:

The Children's Hospital Zhejiang University School of Medicine

Address:

3333 Binsheng Road, Binjiang District

经费或物资来源:

浙江大学医学院附属儿童医院 

Source(s) of funding:

The Children's Hospital Zhejiang University School of Medicine 

研究疾病:

儿童创伤流行病学调查 

Target disease:

epidemiological study of the trauma among children 

研究疾病代码:

 

Target disease code:

 

研究类型:

流行病学研究 

Study type:

Epidemilogical research 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

1、建立中国大陆儿童严重创伤数据库。 2、了解中国大陆儿童严重创伤患者的年龄、疾病、特征、易感高危因素及治疗的疗效等。 3、建立中国大陆儿童严重创伤监测系统及预防模式并加以推广。 

Objectives of Study:

1. To establish a database of children's severe trauma in China mainland. 2. To understand the age, disease, characteristics, risk factors and therapeutic effect of children with severe trauma in China mainland. 3. To establish and popularize the monitoring system and prevention model of children's severe trauma in China mainland. 

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:

一年各个中心严重创伤住院患儿,年龄小于18周岁并且为严重创伤的患儿 

Inclusion criteria

Patients with severe trauma in each center, who are less than 18 years old and have severe trauma 

排除标准:

在ICU的创伤住院患者中年龄≥18岁以及非严重创伤害的患者 

Exclusion criteria:

Patients who are older than 18 years old and without serious injury in ICU 

研究实施时间:

Study execute time:

From2020-01-01To 2022-12-31 

干预措施:

Interventions:

组别:

Case series

样本量:

3000

Group:

Case series

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

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):

杭州 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

浙江大学医学院附属儿童医院 

单位级别:

三甲医院 

Institution
hospital:

The Children's Hospital Zhejiang University School of Medicine  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

年龄、疾病、特征、易感高危因素及治疗的疗效

指标类型:

主要指标 

Outcome:

age, disease, characteristics, risk factors and therapeutic effect

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:

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 18 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):

横断面研究,不是对照研究,不需要随机分配

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

We don't need to randomly assign.

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

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):

浙江大学医学院附属儿童医院多中心临床研究系统

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

Multicenter clinical research system of children's Hospital Zhejiang University School of Medicine

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:

CRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-04-05
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