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白三烯与支气管肺发育不良关系的临床及机制研究
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注册号:

Registration number:

ChiCTR-ORN-16008890 

最近更新日期:

Date of Last Refreshed on:

2016-07-23 

注册时间:

Date of Registration:

2016-07-23 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

白三烯与支气管肺发育不良关系的临床及机制研究 

Public title:

Research on relationship of leukotrienes and bronchopulmonary dysplasia 

注册题目简写:

白三烯与BPD 

English Acronym:

LT and BPD 

研究课题的正式科学名称:

白三烯与支气管肺发育不良关系的临床及机制研究 

Scientific title:

Research on relationship of leukotrienes and bronchopulmonary dysplasia 

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:

章晔 

研究负责人:

陈筱青 

Applicant:

Zhang Ye 

Study leader:

Chen Xiaoqing 

申请注册联系人电话:

Applicant telephone:

+86 13776620765 

研究负责人电话:

Study leader's telephone:

+86 13951676702 

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:

zhangxumeng88@126.com 

研究负责人电子邮件:

Study leader's E-mail:

chenxq2002@foxmail.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:

江苏省南京市江东北路368# 

研究负责人通讯地址:

江苏省鼓楼区虎踞关1-1-1-702 

Applicant address:

368 North Jiangdong Road, Nanjing, Jiangsu, China 

Study leader's address:

1-1, 1-702 Hujuguan, Gulou Distric, Nanjing, Jiangsu, China 

申请注册联系人邮政编码:

Applicant postcode:

210024 

研究负责人邮政编码:

Study leader's postcode:

210024 

申请人所在单位:

南京医科大学第一附属医院/江苏省人民医院 

Applicant's institution:

First affiliated hospital of Nanjing Medical University 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

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:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

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:

南京医科大学第一附属医院/江苏省人民医院 

Primary sponsor:

First affiliated hospital of Nanjing Medical University 

研究实施负责(组长)单位地址:

江苏省南京市鼓楼区广州路300# 

Primary sponsor's address:

300 Guangzhou Road, Gulou district, Nanjing, Jiangsu 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

江苏省

市(区县):

南京市鼓楼区

Country:

China

Province:

Jiangsu

City:

Gulou district, Nanjing

单位(医院):

南京医科大学第一附属医院/江苏省人民医院

具体地址:

江苏省南京市鼓楼区广州路300#

Institution
hospital:

First affiliated hospital of Nanjing Medical University

Address:

300 Guangzhou Road, Gulou district, Nanjing, Jiangsu

经费或物资来源:

自筹 

Source(s) of funding:

self-financing 

研究疾病:

支气管肺发育不良 

Target disease:

Bronchopulmanary 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:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

本研究旨在探讨白三烯拮抗剂孟鲁司特干预早产儿支气管肺发育不良(BPD)的临床评价及其可能机制,阐明孟鲁司特治疗BPD必要性和安全性,为临床BPD的治疗开辟新途径。 

Objectives of Study:

To explore the the evaluation theraputic and mechanisms of leukotriene receptor blockade Montelukast on the bronchopulmanary dysplasia of prematurity (BPD). TO evaluate the efficacy and safety of Montelukast on the intervention of BPD,which will be a new approach for the treatment of BPD. 

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:

1)出生体重<1500g的早生儿; 2)所有患儿的治疗需获父母知情同意。 

Inclusion criteria

1) Premature infants with birth weight <1500 g; 2) Informed written parental consent was required. 

排除标准:

1)严重先天性畸形(21三体综合征,先天性膈疝脐膨出等); 2)严重紫绀型先天性心脏病(如大动脉转位、法乐氏四联症等); 3)患有先天性遗传代谢性疾病; 4)未获得父母的知情同意书。 

Exclusion criteria:

1) Serious congenital malformation (2trisomy 21 syndromecyanotic congenital heart disease,diaphragmatic hernias, etc.); 2) Severe cyanotic type of congenital heart disease (TGA and TOF etc.); 3) Congenital genetic metabolic diseases; 4) Informed written parental consent was not required. 

研究实施时间:

Study execute time:

From2016-07-01To 2017-12-31 

征募观察对象时间:

Recruiting time:

From2016-07-01To 2017-12-31 

干预措施:

Interventions:

组别:

干预组/观察组

样本量:

200

Group:

2

Sample size:

干预措施:

孟鲁司特治疗

干预措施代码:

Intervention:

therapy of Montelukast

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏省 

市(区县):

南京市 

Country:

China 

Province:

Jiangsu 

City:

Nanjing 

单位(医院):

南京医科大学第一附属医院/江苏省人民医院 

单位级别:

三甲 

Institution
hospital:

First affiliated hospital of Nanjing Medical University  

Level of the institution:

Tertiary hospital 

测量指标:

Outcomes:

指标中文名:

死亡率

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:

平均氧疗时间

指标类型:

主要指标 

Outcome:

mean duration of oxygen therapy

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:

尿液

组织:

Sample Name:

urine

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

支气管吸出物

组织:

Sample Name:

tracheal aspirate

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 0 years
最大 Max age 1 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):

观察性研究,非随机

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

observation study, non-randomize

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):

是否共享原始数据:

IPD sharing

是Yes

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):

南京医科大学第一附属医院/江苏省人民医院

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

First affiliated hospital of Nanjing Medical University

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:

Epidata 3.1 录入,SAS 9.2分析, 对统计人员采用盲法原则.

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

Epidata 3.1 input, analysed by SAS 9.2, blinded to statistician.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2016-07-23
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