今天是:2019-07-21 星期日

阻塞性睡眠呼吸暂停患儿分泌性中耳炎发病与免疫相关性研究
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注册号:

Registration number:

ChiCTR1900022630 

最近更新日期:

Date of Last Refreshed on:

2019-04-19 

注册时间:

Date of Registration:

2019-04-19 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

阻塞性睡眠呼吸暂停患儿分泌性中耳炎发病与免疫相关性研究 

Public title:

Study for the relationship between otitis media with effusion and immunity in children with obstructive sleep apnea 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

阻塞性睡眠呼吸暂停患儿分泌性中耳炎发病与免疫相关性研究 

Scientific title:

Study for the relationship between otitis media with effusion and immunity in children with obstructive sleep apnea 

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:

杨文 

研究负责人:

赵宇 

Applicant:

YANG WEN 

Study leader:

ZHAO YU 

申请注册联系人电话:

Applicant telephone:

+86 13550053164 

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:

2808878554@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:

Room 412, Old 8th Teaching Building, West China Hospital, Sichuan University, 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:

其它 

Study phase:

N/A 

研究目的:

分析阻塞性睡眠呼吸暂停患儿分泌性中耳炎发病与免疫相关性 

Objectives of Study:

Analysis of the relationship between otitis media with effusion and immunity 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:

连续入组 

Study design:

Sequential 

纳入标准:

2016.4-2019.4以阻塞性睡眠呼吸暂停为主诉就诊于四川大学华西医院耳鼻咽喉头颈外科学拟行腺样体和/或扁桃体切除手术患儿。 

Inclusion criteria

From April 2016 to April 2019, children complaining of obstructive sleep apnea was admitted to the Department of Otolaryngology, Head and Neck Surgery, West China Hospital of Sichuan University for adenoidectomy and/or tonsillectomy. 

排除标准:

合并其它全身系统性疾病、慢性炎症及免疫系统疾病的患儿 

Exclusion criteria:

Children with other systemic diseases, chronic inflammation and immune system diseases 

研究实施时间:

Study execute time:

From2019-04-26To 2019-10-14 

干预措施:

Interventions:

组别:

Case series

样本量:

680

Group:

Case series

Sample size:

干预措施:

扁桃体腺样体切除术

干预措施代码:

Intervention:

Case series

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:

免疫指标

指标类型:

主要指标 

Outcome:

Immune 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:

BMI指数

指标类型:

次要指标 

Outcome:

Body mass index

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

扁桃体肥大程度

指标类型:

次要指标 

Outcome:

Tonsils grade

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

腺样体肥大程度

指标类型:

次要指标 

Outcome:

Adenoid grade(A/N)

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:

血液

组织:

Sample Name:

blood

Tissue:

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 2 years
最大 Max age 12 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:

 2019-04-19
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