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Early Intervention of Stem Cell Transplantation for Neonates with Hypoxic-ischemic Encephalpathy----a Preliminary Clinical Study
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注册号:

Registration number:

ChiCTR-TNRC-11001591 

最近更新日期:

Date of Last Refreshed on:

2015-07-21 

注册时间:

Date of Registration:

2011-08-17 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

干细胞移植对新生儿缺氧缺血性脑病早期干预的临床研究 

Public title:

Early Intervention of Stem Cell Transplantation for Neonates with Hypoxic-ischemic Encephalpathy----a Preliminary Clinical Study 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

干细胞移植对新生儿缺氧缺血性脑病早期干预的临床研究 

Scientific title:

Early Intervention of Stem Cell Transplantation for Neonates with Hypoxic-ischemic Encephalpathy----a Preliminary Clinical Study 

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:

王晓东 

研究负责人:

安沂华 

Applicant:

Xiaodong Wang 

Study leader:

Yihua An 

申请注册联系人电话:

Applicant telephone:

+86 1057976849 

研究负责人电话:

Study leader's telephone:

+86 1057976849 

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:

xdwang2000@163.com 

研究负责人电子邮件:

Study leader's E-mail:

xdwang2000@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:

北京市海淀区永定路69号 

研究负责人通讯地址:

北京市海淀区永定路69号 

Applicant address:

69 Yongding Road, Haidian District, Beijing 

Study leader's address:

69 Yongding Road, Haidian District, Beijing 

申请注册联系人邮政编码:

Applicant postcode:

100039 

研究负责人邮政编码:

Study leader's postcode:

100039 

申请人所在单位:

中国人民武装警察部队总医院 

Applicant's institution:

General Hospital of Chinese People's Armed Police Forces 

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:

20110813 

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:

中国人民武装警察部队总医院医学伦理委员会 

Name of the ethic committee:

Ethics Committee of General Hospital of the Chinese People’s Armed Police Force 

伦理委员会批准日期:

Date of approved by ethic committee:

2011-06-06 

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:

中国人民武装警察部队总医院 

Primary sponsor:

General Hospital of the Chinese People’s Armed Police Force 

研究实施负责(组长)单位地址:

北京市海淀区学院路15号 

Primary sponsor's address:

15 Xueyuan Road, Haidian 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):

Country:

China

Province:

Beijing

City:

单位(医院):

中国人民武装警察部队总医院

具体地址:

北京市海淀区学院路15号

Institution
hospital:

General Hospital of the Chinese People’s Armed Police Force

Address:

15 Xueyuan Road, Haidian District, Beijing

经费或物资来源:

留学回国人员科研启动基金、武警总医院二类课题 

Source(s) of funding:

Scientific Research Foundation for returned overseas students of China 

研究疾病:

新生儿缺氧缺血性脑病 

Target disease:

hypoxic-ischemic encephalpathy 

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:

I期临床试验 

Study phase:

研究目的:

探讨干细胞移植对新生儿缺氧缺血性脑病早期干预对预后的影响 

Objectives of Study:

To study the effect of stem cell on neonates with hypoxic-ischemic encephalpathy 

药物成份或治疗方案详述:

干细胞 

Description for medicine or protocol of treatment in detail:

stem cell 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

1、足月新生儿 2、Apgar评分:1分钟<=6分,5分钟<10分 ;NBNA<28 

Inclusion criteria

1. full term infants; 2. Apgar: 1min: <=6', 5 min<10', NBNA<28 

排除标准:

遗传代谢性疾病 

Exclusion criteria:

accompanied by other genetic diseases 

研究实施时间:

Study execute time:

From2011-12-01To 2015-12-01 

干预措施:

Interventions:

组别:

A组

样本量:

10

Group:

Group A

Sample size:

干预措施:

常规治疗+干细胞移植

干预措施代码:

Intervention:

routin treatment +stem cell

Intervention code:

组别:

B组

样本量:

10

Group:

Group B

Sample size:

干预措施:

常规治疗+康复

干预措施代码:

Intervention:

routin treatment+rehabilition

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):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国人民武装警察部队总医院 

单位级别:

三级甲等 

Institution
hospital:

中国人民武装警察部队总医院  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

CDCC

指标类型:

主要指标 

Outcome:

CDCC

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

GMFM

指标类型:

主要指标 

Outcome:

GMFM

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

ABC

指标类型:

主要指标 

Outcome:

ABC

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

视、听、体感觉诱发电位

指标类型:

主要指标 

Outcome:

visua v evoke potential, Brainstem Auditory Evoked Potential, somatosensory evoked potentials (SEP)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

NBNA

指标类型:

主要指标 

Outcome:

NBNA

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

FMFM

指标类型:

主要指标 

Outcome:

FMFM

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

EEG

指标类型:

次要指标 

Outcome:

EEG

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:

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 years
最大 Max age 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):

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

no

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Real time access

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):

中国人民武装警察部队总医院

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

General Hospital of the Chinese People’s Armed Police Force

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:

中国人民武装警察部队总医院

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

General Hospital of the Chinese People’s Armed Police Force

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2011-08-17
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