今天是:2019-08-22 星期四

2019年重庆0-3岁儿童食物过敏流行病学研究
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注册号:

Registration number:

ChiCTR1900024338 

最近更新日期:

Date of Last Refreshed on:

2019-07-06 

注册时间:

Date of Registration:

2019-07-06 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

2019年重庆0-3岁儿童食物过敏流行病学研究 

Public title:

An epidemiological study for food allergy in children aged 0-3 years old in chongqing, 2019 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

2019年重庆0-3岁儿童食物过敏流行病学研究 

Scientific title:

An epidemiological study for food allergy in children aged 0-3 years old in chongqing, 2019 

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:

马卓颖 

研究负责人:

胡燕 

Applicant:

Ma Zhuoying 

Study leader:

Hu Yan 

申请注册联系人电话:

Applicant telephone:

+86 18673489166 

研究负责人电话:

Study leader's telephone:

+86 13896015172 

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:

mzy1011@126.com 

研究负责人电子邮件:

Study leader's E-mail:

hy420@126.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:

重庆市渝中区中山二路136号 

研究负责人通讯地址:

重庆市渝中区中山二路136号 

Applicant address:

136 Second Zhongshan Road, Yuzhong District, Chongqing, China 

Study leader's address:

136 Second Zhongshan Road, Yuzhong District, Chongqing, 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:

重庆医科大学附属儿童医院 

Applicant's institution:

Children's Hospital Affiliated to Chongqing Medical University 

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:

(2019)年轮审(研)第(103)号 

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:

重庆医科大学附属儿童医院医学研究伦理委员会 

Name of the ethic committee:

Institutional Review Board, Children's Hospital of Chongqing Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-05-17 

伦理委员会联系人:

袁老师 

Contact Name of the ethic committee:

Mr. Yuan 

伦理委员会联系地址:

重庆市渝中区中山二路136号 

Contact Address of the ethic committee:

136 Second Zhongshan Road, Yuzhong District, Chongqing, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 023 63664659 

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:

重庆医科大学附属儿童医院 

Primary sponsor:

Children's Hospital Affiliated to Chongqing Medical University 

研究实施负责(组长)单位地址:

重庆市渝中区中山二路136号 

Primary sponsor's address:

136 Second Zhongshan Road, Yuzhong District, Chongqing, 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):

重庆市

市(区县):

渝中区

Country:

China

Province:

Chongqing

City:

YUzhong District

单位(医院):

重庆医科大学附属儿童医院

具体地址:

重庆市渝中区中山二路136号

Institution
hospital:

Children's Hospital Affiliated to Chongqing Medical University

Address:

136 Second Zhongshan Road, Yuzhong District, Chongqing, China

经费或物资来源:

自筹 

Source(s) of funding:

self-collected 

研究疾病:

食物过敏 

Target disease:

food allerge 

研究疾病代码:

 

Target disease code:

 

研究类型:

卫生服务研究 

Study type:

Health services reaserch 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

了解重庆地区0-36个月儿童食物过敏的患病情况及其临床症状,以利其诊疗和预防。 

Objectives of Study:

To understand the prevalence and clinical symptoms of food allergy in children aged 0-36 months in chongqing and for the purpose of diagnosis, treatment and prevention 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

(1)≤3岁的健康儿童; (2)智能发育正常; (3)愿意加入该临床研究并签署知情同意书 

Inclusion criteria

(1) Healthy children <=3 years old; (2) Intelligence develops normally; (3) Willing to participate in the clinical study and sign the informed consent. 

排除标准:

(1)患有急性病症或严重慢性疾病; (2)患有遗传代谢等先天性疾病; (3)存在明确行为发育偏离者 

Exclusion criteria:

(1) Acute illness or severe chronic disease; (2) Congenital diseases such as genetic metabolism; (3) Clear behavioral developmental deviations  

研究实施时间:

Study execute time:

From2019-07-01To 2019-09-30 

干预措施:

Interventions:

组别:

Case series

样本量:

500

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):

重庆市 

市(区县):

渝中区 

Country:

China 

Province:

Chongqing 

City:

Yuzhong District 

单位(医院):

重庆医科大学附属儿童医院 

单位级别:

三甲 

Institution
hospital:

Children's hospital affiliated to chongqing medical university  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

皮肤点刺试验

指标类型:

主要指标 

Outcome:

skin prick rest

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 3 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):

于我院儿保科门诊就诊0-3岁的儿童

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

N/A

盲法:

N/A

Blinding:

N/A

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

发表论文形式公开

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

share IPD with papers published

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:

Case record form

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-07-06
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