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异体脐带血防治早产儿支气管肺发育不良
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注册号:

Registration number:

ChiCTR-OPN-15006932 

最近更新日期:

Date of Last Refreshed on:

2015-08-17 

注册时间:

Date of Registration:

2015-08-17 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

异体脐带血防治早产儿支气管肺发育不良 

Public title:

Prevention and treatment of Bronchopulmonary Dysplasia with Allogeneic Cord blood mononuclear cells 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

异体脐带血防治早产儿支气管肺发育不良的临床研究 

Scientific title:

Prevention and treatment of Bronchopulmonary Dysplasia with Allogeneic Cord blood mononuclear cells 

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:

梅亚波 

研究负责人:

封志纯 

Applicant:

Mei Yabo 

Study leader:

Fengzhichun 

申请注册联系人电话:

Applicant telephone:

+86 010-84008805 

研究负责人电话:

Study leader's telephone:

+86 010-66721786 

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:

myb2003@163.com 

研究负责人电子邮件:

Study leader's E-mail:

Zhjfengzc@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:

北京市东城区南门仓5号 

研究负责人通讯地址:

北京市东城区南门仓5号 

Applicant address:

5 Nanmencang, Dongcheng District, Beijing, China 

Study leader's address:

5 Nanmencang, Dongcheng District, Beijing, China 

申请注册联系人邮政编码:

Applicant postcode:

100700 

研究负责人邮政编码:

Study leader's postcode:

100700 

申请人所在单位:

中国人民解放军北京军区总医院 

Applicant's institution:

The General Hospital of Beijing Military Region of PLA 

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:

2015110 

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:

中国人民解放军北京军区总医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of The General Hospital of Beijing Military Region of PLA 

伦理委员会批准日期:

Date of approved by ethic committee:

2015-08-12 

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:

中国人民解放军北京军区总医院 

Primary sponsor:

The General Hospital of Beijing Military Region of PLA 

研究实施负责(组长)单位地址:

北京市东城区南门仓5号 

Primary sponsor's address:

5 Nanmencang, Dongcheng District, Beijing, 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):

北京市

市(区县):

东城区

Country:

China

Province:

Beijing

City:

Dongcheng District

单位(医院):

中国人民解放军北京军区总医院

具体地址:

北京市东城区南门仓5号

Institution
hospital:

The General Hospital of Beijing Military Region of PLA

Address:

5 Nanmencang, Dongcheng District, Beijing, China

经费或物资来源:

儿童器官功能衰竭北京市重点实验室2015年度科技创新基本培育与发展专项项目 

Source(s) of funding:

2015 fiscal basic foster technological innovation and development special projects of Beijing Key Laboratory of Children's Organ Failure 

研究疾病:

支气管肺发育不良 

Target disease:

Bronchopulmonary Dysplasia 

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:

I期+II期 

Study phase:

1-2 

研究目的:

评价异体健康足月儿脐血输注对早产儿BPD的疗效和安全性。 

Objectives of Study:

The efficacy and safety evaluation of allogeneic cord blood transfusion for BPD in preterm children 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

治疗试验入选标准:(需同时符合) 1)生后≥28天; 2)需氧疗,FiO2>21%; 3)家长阅读了受试者须知,同意治疗并签署书面知情同意书。 预防试验入选标准:(需同时符合) 1)出生胎龄≤31周; 2)出生体重401-1249g之间; 3)入院第3天BPD风险≥60%;,评分依据:NICHD新生儿合作网络建立的BPD高危评分系统; 4)家长阅读了受试者须知,同意治疗并签署书面知情同意书。 

Inclusion criteria

Treatment trials to simultaneously meet the eligibility criteria : 1. >=28 days after birth; 2. oxygen supplement, FiO2> 21%; 3. Parents read the notes subject, consent to treatment and signed a written informed consent. Prevention trial to simultaneously meet the eligibility criteria: 1. gestational age <=31 weeks; 2. birth weight between 401-1249g; 3. the first three days of admission BPD risk >=60% ; score based: BPD-risk scoring system (NICHD neonatal network); 4. Parents read the notes subject, consent to treatment and signed a written informed consent. 

排除标准:

治疗试验:病例排除标准(符合其中1条即排除) 1)年龄<28天; 2)严重先天异常; 3)不能或不愿提供知情同意或不能遵守试验要求者; 预防试验:病例排除标准(符合其中1条即排除) 1)出生胎龄>31周; 2)出生体重<401g或>1249g; 3)入院第3天BPD风险<60% 4)严重先天异常; 5)不能或不愿提供知情同意或不能遵守试验要求者; 

Exclusion criteria:

Treatment Trial: Case exclusion criteria (according to which one that is excluded) 1. Age <28 days; 2. severe congenital anomalies; 3. unable or unwilling to provide informed consent or who can not comply with the test requirements; Prevention trials: Case exclusion criteria (according to which one that is excluded) 1) gestational age> 31 weeks; 2) birth weight <401g or> 1249g; 3) the first three days of admission BPD risk <60% 4) severe congenital anomalies; 5) unable or unwilling to provide informed consent or who can not comply with the test requirements. 

研究实施时间:

Study execute time:

From2015-08-12To 2016-08-16 

干预措施:

Interventions:

组别:

预防组

样本量:

15

Group:

prevention group

Sample size:

干预措施:

异体脐血细胞

干预措施代码:

Intervention:

Allogeneic umbilical cord blood cells

Intervention code:

组别:

治疗组

样本量:

15

Group:

Treatment group

Sample size:

干预措施:

异体脐血细胞

干预措施代码:

Intervention:

Allogeneic umbilical cord blood cells

Intervention code:

组别:

对照组

样本量:

30

Group:

Control groups

Sample size:

干预措施:

生理盐水

干预措施代码:

Intervention:

normal saline

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 

市(区县):

东城区 

Country:

China 

Province:

Beijing 

City:

Dongcheng District 

单位(医院):

中国人民解放军北京军区总医院 

单位级别:

三级医院 

Institution
hospital:

The General Hospital of Beijing Military Region of PLA  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

用氧时间

指标类型:

主要指标 

Outcome:

the time of oxygen supplement

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

BPD分级

指标类型:

主要指标 

Outcome:

Grade of BPD

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

死亡

指标类型:

主要指标 

Outcome:

Death

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

出院时间

指标类型:

次要指标 

Outcome:

Discharge time

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:

支气管灌洗液

组织:

Sample Name:

Bronchoalveolar lavage

Tissue:

no

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

no

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):

非随机临床对照试验

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

Non-randomized controlled clinical trials

盲法:

Blinding:

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:

即时公开/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):

中国人民解放军北京军区总医院

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

the General Hospital of Beijing Military Region of PLA

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:

中国人民解放军北京军区总医院

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

the General Hospital of Beijing Military Region of PLA

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2015-08-17
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