消毒与儿童感染性疾病关系研究

注册号:

Registration number:

ChiCTR-TRC-12002705 

最近更新日期:

Date of Last Refreshed on:

2015-12-16 22:29:12 

注册时间:

Date of Registration:

2012-09-22 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

消毒与儿童感染性疾病关系研究

Public title:

Research on the impact of cleaning and disinfection measures for infectious diseases of children

注册题目简写:

English Acronym:

研究课题的正式科学名称:

消毒与儿童感染性疾病关系研究

Scientific title:

Research on the impact of infectious diseases of children by cleaning and disinfection measures

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:

班海群 

研究负责人:

张流波 

Applicant:

Ban Haiqun 

Study leader:

Zhang Liubo 

申请注册联系人电话:

Applicant telephone:

+86 010 67717125

研究负责人电话:

Study leader's
telephone:

+86 010 87779905

申请注册联系人传真 :

Applicant Fax:

+86 010 87779905

研究负责人传真:

Study leader's fax:

+86 010 87779905

申请注册联系人电子邮件:

Applicant E-mail:

banhaiqun@163.com

研究负责人电子邮件:

Study leader's E-mail:

zlbxj@263.net

申请单位网址(自愿提供):

Applicant website(voluntary supply):

http://www.hygiene.net.cn

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:

北京市朝阳区潘家园南里7号

研究负责人通讯地址:

北京市朝阳区潘家园南里7号

Applicant address:

7 Panjiayuan Nanli, Chaoyang District, Beijing

Study leader's address:

7 Panjiayuan Nanli, Chaoyang District, Beijing

申请注册联系人邮政编码:

Applicant postcode:

100021

研究负责人邮政编码:

Study leader's postcode:

100021

申请人所在单位:

中国疾病预防控制中心环境与健康相关产品安全所

Applicant's institution:

Institute of Environment Health and Related Product Safety, China CDC

研究负责人所在单位:

Affiliation of the Leader:

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

2012001

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

中国疾病预防控制中心环境与健康相关产品安全所医学伦理审查委员会

Name of the ethic committee:

Institute of Environment Health and Related Product Safety Ethics Committee

伦理委员会批准日期:

Date of approved by ethic committee:

2012-09-12 00:00:00

伦理委员会联系人:

Contact Name of the ethic committee:

伦理委员会联系地址:

Contact Address of the ethic committee:

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:

中国疾病预防控制中心环境与健康相关产品安全所

Primary sponsor:

Institute of Environment Health and Related Product Safety, China CDC

研究实施负责(组长)单位地址:

北京市朝阳区潘家园南里7号

Primary sponsor's address:

.7 Panjiayuan Nanli, Chaoyang District, Beijing

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

朝阳

Country:

China

Province:

Beijng

City:

Chaoyang District

单位(医院):

中国疾病预防控制中心环境与健康相关产品安全所

具体地址:

北京市朝阳区潘家园南里7号

Institution
hospital:

Institute of Environment Health and Related Product Safety, China CDC

Address:

7 Panjiayuan Nanli, Chaoyang District, Beijing

经费或物资来源:

威莱(广州)日用品有限公司

Source(s) of funding:

the Whealthfields Lohmann (Guangzhou) Company Ltd.

研究疾病:

儿童感染性疾病  

Target disease:

infectious diseases in children

研究疾病代码:

Target disease code:

研究类型:

干预性研究

Study type:

Interventional study

研究所处阶段:

其它 

Study phase:

N/A

研究设计:

随机平行对照 

Study design:

Parallel 

研究目的:

在幼儿园和家庭中开展清洁消毒干预措施,评价手卫生和环境清洁消毒干预措施对儿童感染性疾病的预防效果,可为该类疾病新的预防策略提供依据。  

Objectives of Study:

Through this study of these infectious diseases, the prevention effect of intervention measures(hand hygiene and environmental cleaning or disinfection) will be clarified primarily, which can provide a foundation for further researching on the mechanism of contact transmission and developing new prevention strategies.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

Inclusion criteria

排除标准:

排除患有严重疾病或先天性疾病者

Exclusion criteria:

Who have serious disease or congenital diseases.

研究实施时间:

Study execute time:

From 2012-09-01 00:00:00 To 2013-10-31 00:00:00  

征募观察对象时间:

Recruiting time:

From 2012-09-01 00:00:00 To 2012-09-30 00:00:00

干预措施:

Interventions:

组别:

干预组

样本量:

360

Group:

intervention group

Sample size:

干预措施:

手卫生

干预措施代码:

Intervention:

hand hygiene

Intervention code:

组别:

干预组

样本量:

360

Group:

intervention group

Sample size:

干预措施:

环境物体表面清洁消毒

干预措施代码:

Intervention:

surface cleaning or disinfection

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

北京 

市(区县):

东城区 

Country:

China

Province:

Beijing

City:

Dongcheng District

单位(医院):

北京市第一幼儿园 

单位级别:

一级一类 

Institution
hospital:

First kindergarten of Beijing

Level of the institution:

first class

国家:

中国

省(直辖市):

北京 

市(区县):

东城区 

Country:

China

Province:

Beijing

City:

Dongcheng District

单位(医院):

东城区东四五条幼儿园 

单位级别:

一级一类 

Institution
hospital:

Dongsiwutiao kindergarten of Dongcheng

Level of the institution:

first class

国家:

中国

省(直辖市):

北京 

市(区县):

朝阳区 

Country:

China

Province:

Beijing

City:

Chaoyang District

单位(医院):

朝阳区亚运村第二幼儿园 

单位级别:

一级一类 

Institution
hospital:

Second Asian Sports village kindergarten of Chaoyang

Level of the institution:

first class

国家:

中国

省(直辖市):

北京 

市(区县):

朝阳区 

Country:

China

Province:

Beijing

City:

Chaoyang District

单位(医院):

朝阳区劲松第二幼儿园 

单位级别:

一级一类 

Institution
hospital:

Second Jinsong kindergarten of Chaoyang

Level of the institution:

first class

国家:

中国

省(直辖市):

上海 

市(区县):

杨浦区 

Country:

China

Province:

Shanghai

City:

Yangpu District

单位(医院):

畅想艺术幼稚园 

单位级别:

一级 

Institution
hospital:

Changxiang Art kindergarten

Level of the institution:

first class

国家:

中国

省(直辖市):

上海 

市(区县):

杨浦区 

Country:

China

Province:

Shanghai

City:

Yangpu District

单位(医院):

杨浦幼儿园 

单位级别:

示范园 

Institution
hospital:

kindergarten of Yangpu

Level of the institution:

model class

国家:

中国

省(直辖市):

上海 

市(区县):

徐汇区 

Country:

China

Province:

Shanghai

City:

Xuhui District

单位(医院):

上海幼儿园上中分园 

单位级别:

一级 

Institution
hospital:

Shangzhong Division of Shanghai kindergarten

Level of the institution:

first class

国家:

中国

省(直辖市):

上海 

市(区县):

徐汇区 

Country:

China

Province:

Shanghai

City:

Xuhui District

单位(医院):

上海幼儿园凌云分园 

单位级别:

一级 

Institution
hospital:

Lingyun Division of Shanghai kindergarten

Level of the institution:

first class

国家:

中国

省(直辖市):

湖北 

市(区县):

仙桃市 

Country:

China

Province:

Hubei

City:

Xiantao

单位(医院):

德政幼儿园 

单位级别:

示范园 

Institution
hospital:

Dezheng kindergarten

Level of the institution:

model class

国家:

中国

省(直辖市):

湖北 

市(区县):

仙桃市 

Country:

China

Province:

Hubei

City:

Xiantao

单位(医院):

育才幼儿园 

单位级别:

示范园 

Institution
hospital:

Yucai kindergarten

Level of the institution:

model class

测量指标:

Outcomes:

指标中文名:

感染性疾病症状

指标类型:

主要指标

Outcome:

infectious diseases symptoms

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

因病缺课

指标类型:

主要指标

Outcome:

illness absenteeism

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

环境微生物

指标类型:

次要指标

Outcome:

Environmental Microbiology

Type:

Secondary 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:

组织:

Sample Name:

none

Tissue:

none

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:

结束

/Completed

年龄范围:

Participant age:

最小 Min age 3 years
最大 Max age 5 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):

整群随机

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

clustor Randomization

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法:

Blinding:

None

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

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):

中国疾病预防控制中心环境与健康相关产品安全所

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

Institute of Environment Health and Related Product Safety, China CDC

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:

中国疾病预防控制中心环境与健康相关产品安全所

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

Institute of Environment Health and Related Product Safety, China CDC

数据与安全监察委员会:

Data and Safety Monitoring Committee:

注册人:

Name of Registration:

 2012-11-21 00:00:00