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血栓前状态与儿童阻塞性睡眠呼吸暂停综合征的相关性研究:基于病历记录的分析
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注册号:

Registration number:

ChiCTR1900022254 

最近更新日期:

Date of Last Refreshed on:

2019-04-01 

注册时间:

Date of Registration:

2019-04-01 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

血栓前状态与儿童阻塞性睡眠呼吸暂停综合征的相关性研究:基于病历记录的分析 

Public title:

Correlation between obstructive sleep apnea-hypopnea syndrome and prethrombotic state in children: a case records based study 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

血栓前状态与儿童阻塞性睡眠呼吸暂停综合征的相关性研究 

Scientific title:

Correlation between obstructive sleep apnea-hypopnea syndrome and prethrombotic state in children: a case records based study 

研究课题代号(代码):

Study subject ID:

四川省科技厅课题(No.2016HH0064) 

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:

王晶 

研究负责人:

赵宇 

Applicant:

WANG JING 

Study leader:

ZHAO YU 

申请注册联系人电话:

Applicant telephone:

+86 18782951113 

研究负责人电话:

Study leader's telephone:

+86 18782951113 

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:

471751695@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

yutzhao@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:

四川省成都市国学巷37号 

研究负责人通讯地址:

四川省成都市国学巷37号四川大学华西医院 

Applicant address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China 

Study leader's address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China 

申请注册联系人邮政编码:

Applicant postcode:

610041 

研究负责人邮政编码:

Study leader's postcode:

610041 

申请人所在单位:

四川大学华西医院 

Applicant's institution:

West China Hospital, Sichuan 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:

2018-146 

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:

四川大学华西医院生物医学伦理分委会 

Name of the ethic committee:

the Biological and Medical Ethics Committee (BMEC) of West China Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-05-10 

伦理委员会联系人:

左泽锦 

Contact Name of the ethic committee:

Zuo Zejin 

伦理委员会联系地址:

成都市武侯区国学巷37号四川大学华西医院老八教四楼412室 

Contact Address of the ethic committee:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 028 85422654 

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:

四川大学华西医院 

Primary sponsor:

West China Hospital, Sichuan University 

研究实施负责(组长)单位地址:

四川省成都市国学巷37号 

Primary sponsor's address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, 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):

四川

市(区县):

成都

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

四川大学华西医院

具体地址:

四川省成都市国学巷37号

Institution
hospital:

West China Hospital, Sichuan University

Address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China

经费或物资来源:

四川省科技厅课题(No.2016HH0064). 

Source(s) of funding:

the International Scientific and Technological Cooperation Projects of Sichuan Province (No.2016HH0064).  

研究疾病:

阻塞性睡眠呼吸暂停低通气综合征 

Target disease:

Obstructive sleep apnea hypopnea syndrome 

研究疾病代码:

 

Target disease code:

 

研究类型:

基础科学研究 

Study type:

Basic Science 

研究所处阶段:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

分析比较肥胖、超重和正常体重的阻塞性睡眠呼吸暂停患儿的血栓前状态 

Objectives of Study:

To compare the prethrombotic state of obesity, overweight and normal weight in children with obstructive sleep apnea. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

纳入标准:

2013.1-2019.3于四川大学华西医院行多导睡眠监测的2-18岁患儿 

Inclusion criteria

2-18 year old children with polysomnography were performed from 2013.1-2019.3 in West China hospital.  

排除标准:

排除残疾患儿( 如听力、视力、语言、智力等残疾) ,某些先天性疾病患儿( 如Treacher Collins 综合征、Crouson 综合征、 Down 综合征等) 

Exclusion criteria:

Children with disabilities (such as hearing, vision, language, intelligence, etc.) and children with certain congenital diseases (such as Treacher Collins syndrome, Crouson syndrome, Down syndromeetc and etc.). 

研究实施时间:

Study execute time:

From2019-04-02To 2019-11-02 

干预措施:

Interventions:

组别:

肥胖、超重和正常体重的阻塞性睡眠呼吸暂停患儿

样本量:

400

Group:

obesity, overweight and normal weight children

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):

四川 

市(区县):

成都 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

四川大学华西医院 

单位级别:

三甲 

Institution
hospital:

West China Hospital, Sichuan University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

多导睡眠监测

指标类型:

主要指标 

Outcome:

polysomnography

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

BMI指数

指标类型:

主要指标 

Outcome:

Body mass index

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 examination

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

凝血指标

指标类型:

主要指标 

Outcome:

coagulation index

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 2 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):

非随机

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

N/A

盲法:

N/A

Blinding:

N/A

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:

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):

投稿时附件上传

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

Uploading attachments to contributors

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:临床检查报告单、病历。电子采集和管理系统:EXCEL表

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

CRF:clinical examination report form and medical record. EDC: EXCEL table

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-04-01
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