Today is 2021-07-24

A prospective study on the clinical characteristics of neonatal hyperbilirubinemia caused by congenital liver disease
download

注册号:

Registration number:

ChiCTR2100047697 

最近更新日期:

Date of Last Refreshed on:

2021-06-22 

注册时间:

Date of Registration:

2021-06-22 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

先天性肝病致新生儿高胆红素血症临床特点前瞻性研究 

Public title:

A prospective study on the clinical characteristics of neonatal hyperbilirubinemia caused by congenital liver disease 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

先天性肝病致新生儿高胆红素血症临床特点前瞻性研究 

Scientific title:

A prospective study on the clinical characteristics of neonatal hyperbilirubinemia caused by congenital liver disease 

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:

王凤 

研究负责人:

王凤 

Applicant:

Wang Feng 

Study leader:

Wang Feng 

申请注册联系人电话:

Applicant telephone:

18600317210 

研究负责人电话:

Study leader's telephone:

18600317210 

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:

wf_316@sina.com 

研究负责人电子邮件:

Study leader's E-mail:

wf_316@sina.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:

No.5 Nanmencang, Dongcheng District, Beijing 

Study leader's address:

No.5 Nanmencang, Dongcheng District, Beijing 

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:

解放军总医院第七医学中心儿科医学部新生儿科 

Applicant's institution:

Neonatal intensive care unit of department of Pediatrics, Seventh Medical Center, PLA General Hospital 

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:

2021-40 

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:

解放军总医院第七医学中心伦理委员会 

Name of the ethic committee:

Ethical Committee of the Seventh Medical Center of PLA General Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

杨蓉娅 

Contact Name of the ethic committee:

Yang Rongya 

伦理委员会联系地址:

北京市东城区南门仓5号 

Contact Address of the ethic committee:

No.5 Nanmencang, Dongcheng District, Beijing 

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:

解放军总医院第七医学中心儿科医学部新生儿科 

Primary sponsor:

Neonatal intensive care unit of department of Pediatrics, Seventh Medical Center, PLA General Hospital 

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:

No.5 Nanmencang, Dongcheng 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):

解放军总医院第七医学中心

具体地址:

北京市东城区南门仓5号

Institution
hospital:

Seventh Medical Center, PLA General Hospital

Address:

No.5 Nanmencang, Dongcheng District, Beijing

经费或物资来源:

自筹经费 

Source(s) of funding:

self-financing 

研究疾病:

先天性肝病 

Target disease:

congenital liver disease 

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期临床试验 

Study phase:

研究目的:

通过对先天性肝病致新生儿高胆红素血症患儿进行住院期间临床观察、完善各类生化、先天性遗传代谢检查及基因检测,出院后长期跟踪随访,分析其临床特点及远期预后情况。 

Objectives of Study:

The clinical characteristics and long-term prognosis of neonatal hyperbilirubinemia caused by congenital liver disease will be observed analyzed through congenital genetic and metabolic examination and gene detection during hospitalization and long-term follow-up after discharge. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

a.新生儿高胆红素血症 b.确诊肝豆状核变性、Gilbert综合征、 Crigler-Najjar综合征、Dubin-Johnson综合征、家族性肝内胆汁淤积症 

Inclusion criteria

A. Neonatal hyperbilirubinemia B. Diagnosed hepatolenticular degeneration,Gilbert syndrome,Crigler-Najjar syndrome,Dubin-Johnson syndrome and familial intrahepatic cholestasis 

排除标准:

a.先天性胆道闭锁 b.先天性胆管囊肿 c.新生儿败血症 e.超过2周静脉营养 f.各脏器衰竭 g.休克 h.家长不同意完善家系基因检测或后期随访者。 

Exclusion criteria:

A. Congenital biliary atresia B. Congenital bile duct cyst C. Neonatal sepsis E. Intravenous nutrition for more than 2 weeks F. Organ failure G. shock H. Parents do not agree to improve pedigree genetic testing or follow-up visits. 

研究实施时间:

Study execute time:

From2021-06-22To 2026-06-22 

征募观察对象时间:

Recruiting time:

From2021-06-22To 2026-06-22 

干预措施:

Interventions:

组别:

观察组

样本量:

20

Group:

observation

Sample size:

干预措施:

观察

干预措施代码:

Intervention:

observation

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:

北京 

City:

 

单位(医院):

解放军总医院第七医学中心 

单位级别:

三级甲等 

Institution
hospital:

Seventh Medical Center, PLA General Hospital  

Level of the institution:

Grade three Class 1 

测量指标:

Outcomes:

指标中文名:

血清总胆红素

指标类型:

主要指标 

Outcome:

serum total bilirubin

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血清直接胆红素

指标类型:

主要指标 

Outcome:

serum direct bilirubin

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

谷丙转氨酶

指标类型:

主要指标 

Outcome:

glutamic-pyruvic transaminase

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肝脏超声

指标类型:

主要指标 

Outcome:

liver ultrasound

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

代谢血筛查

指标类型:

主要指标 

Outcome:

Metabolic Blood Screening

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Metabolic urine Screening

指标类型:

主要指标 

Outcome:

Metabolic Blood Screening

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

基因二代测序额

指标类型:

主要指标 

Outcome:

Next generation sequencing

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

发育评估

指标类型:

主要指标 

Outcome:

development assessment

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:

blood

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:

尿

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:

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 years
最大 Max age years

性别:

男性

Gender:

Male

随机方法(请说明由何人用什么方法产生随机序列):

统计人员采用电脑程序产生随机序列

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

Statisticians use a computer program to generate random sequences

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):

是否共享原始数据:

IPD sharing

No

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):

2028/10/01

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

2028/10/01

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:

病历记录表

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

Case Record Form

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2021-06-22
return list