今天是:2020-08-11 星期二

新生儿使用硫酸丁胺卡那霉素临床分析
下载XML文档

注册号:

Registration number:

ChiCTR2000034644 

最近更新日期:

Date of Last Refreshed on:

2020-07-13 

注册时间:

Date of Registration:

2020-07-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

新生儿使用硫酸丁胺卡那霉素临床分析 

Public title:

The usage of amikacin sulfate in neonates 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

104例新生儿使用硫酸丁胺卡那霉素临床分析 

Scientific title:

The usage of amikacin sulfate in 104 neonates 

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:

胡又宁 

研究负责人:

王政力 

Applicant:

Youning Hu 

Study leader:

Zhengli Wang 

申请注册联系人电话:

Applicant telephone:

+86 13890781557 

研究负责人电话:

Study leader's telephone:

+86 18580183566 

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:

958479747@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

dengcgcb@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:

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 Dstrict, 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 of 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:

(2020)年伦审(研)第(26)号 

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:

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 of Children's Hospital of Chongqing Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-04-29 

伦理委员会联系人:

重庆医科大学附属儿童医院医学研究伦理委员会 

Contact Name of the ethic committee:

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

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 of 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(区县):

Country:

China

Province:

Chongqing

City:

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 of Chongqing Medical University

Address:

136 Second Zhongshan Road, Yuzhong District

经费或物资来源:

自费 

Source(s) of funding:

self-paying 

研究疾病:

新生儿败血症 

Target disease:

Neonatal septicemia 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

本研究将通过回顾性研究重庆医科大学儿童医院2013.01-2018.12静脉使用阿米卡星的患儿的临床特征,评估其耳毒性和肾毒性,为阿米卡星在新生儿中的使用提供参考。 

Objectives of Study:

This study will retrospectively study the clinical characteristics of intravenous amikacin in Children's Hospital of Chongqing Medical University from 2013.01 to 2018.12, and evaluate its ototoxicity and nephrotoxicity, so as to provide reference for the use of amikacin in newborns. 

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入院日龄/或纠正胎龄0-28天; ②住院期间使用阿米卡星 

Inclusion criteria

1. Age of admission / or the corrected gestational age of 0-28 days. 2. usage of amikacin during hospitalization. 

排除标准:

①有严重的先天性畸形 ②非静脉使用 ③病历资料不完整 

Exclusion criteria:

1. has severe congenital malformation; 2. non-intravenous use; 3. the medical records are incomplete. 

研究实施时间:

Study execute time:

From2020-05-01To 2020-10-01 

征募观察对象时间:

Recruiting time:

From2020-07-20To 2020-08-20 

干预措施:

Interventions:

组别:

Case series

样本量:

104

Group:

Case series

Sample size:

干预措施:

干预措施代码:

Intervention:

none

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(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

重庆医科大学附属儿童医院 

单位级别:

三级甲等医院 

Institution
hospital:

Children's Hospital of Chongqing Medical University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

肾功能

指标类型:

主要指标 

Outcome:

Renal function

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

听力

指标类型:

主要指标 

Outcome:

Hearing

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:

标本中文名:

组织:

Sample Name:

none

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 0 years
最大 Max age 0 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):

不适用

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

Not applicable

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):

邮箱

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

E-mail

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:

由1人完成数据收集

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

one person to complete the data collection

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-07-12
返回列表