今天是:2019-06-17 星期一

早产儿视网膜病变代谢组学分析研究
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注册号:

Registration number:

ChiCTR1900020677 

最近更新日期:

Date of Last Refreshed on:

2019-01-12 

注册时间:

Date of Registration:

2019-01-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

早产儿视网膜病变代谢组学分析研究 

Public title:

Metabolic analysis of retinopathy of prematurity 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

早产儿视网膜病变代谢组学分析研究 

Scientific title:

Metabolic analysis of retinopathy of prematurity 

研究课题代号(代码):

Study subject ID:

JCY20140414114853651 

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:

杨宇航 

研究负责人:

张国明 

Applicant:

Yuhang Yang 

Study leader:

Guoming Zhang 

申请注册联系人电话:

Applicant telephone:

+86 13751350913 

研究负责人电话:

Study leader's telephone:

+86 13823509060 

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:

635398767@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

13823509060@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:

广东省深圳市福田区香蜜湖街道泽田路18号深圳市眼科医院 

研究负责人通讯地址:

广东省深圳市福田区香蜜湖街道泽田路18号深圳市眼科医院 

Applicant address:

18 Zetian Road, Shenzhen, Guangdong, China 

Study leader's address:

18 Zetian Road, Shenzhen, Guangdong, China 

申请注册联系人邮政编码:

Applicant postcode:

518040 

研究负责人邮政编码:

Study leader's postcode:

518040 

申请人所在单位:

深圳市眼科医院 

Applicant's institution:

Shenzhen eye 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:

2018070502 

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:

深圳市眼科医院伦理委员会 

Name of the ethic committee:

Ethics committee of Shenzhen eye hospital 

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:

赵军 

Contact Name of the ethic committee:

Jun Zhao 

伦理委员会联系地址:

广东省深圳市福田区香蜜湖街道泽田路18号深圳市眼科医院 

Contact Address of the ethic committee:

Shenzhen Eye Hospital, the Second Affiliated Hospital of Jinan University, 18 Zetian Road, Shenzhen, Guangdong, China 

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:

深圳市眼科医院 

Primary sponsor:

Shenzhen Eye Hospital 

研究实施负责(组长)单位地址:

广东省深圳市福田区香蜜湖街道泽田路18号深圳市眼科医院 

Primary sponsor's address:

Shenzhen Eye Hospital,the Second Affiliated Hospital of Ji'nan University, 18 Zetian Road, Shenzhen, Guangdong, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

深圳市新生儿致盲眼病防治体系建设。深圳市科创委基础研究项目(JCY20140414114853651)。2014/8-2016/8,第一负责人20万 

Source(s) of funding:

Construction of prevention and treatment system for neonatal blindness in Shenzhen; Basic research project of Shenzhen Science and Innovation Commission (JCY20140414114853651) 

研究疾病:

早产儿视网膜病变 

Target disease:

retinopathy of prematurity 

研究疾病代码:

 

Target disease code:

 

研究类型:

病因学/相关因素研究 

Study type:

Cause/Relative factors study 

研究所处阶段:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

应用运用超高效液相色谱-串联质谱技术(ultra performance liquid chromatography-mass spectrometry/mass spectrometry, UPLC-MS/MS)的代谢组学测试平台,检测早产儿视网膜病变(retinopathy of prematurity,ROP)患儿外周血中不同代谢产物种类的非靶标的 (untargeted) UPLC-MS/MS分析,小分子代谢物质差异,寻找ROP的血代谢特殊生物标记物。 

Objectives of Study:

To investigate the potential biomarkers of blood of retinopathy of prematurity (ROP) by metabolomics. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

病例对照研究 

Study design:

Case-Control study 

纳入标准:

观察组:重度需治疗ROP患儿(阈值期、阈值前1型及AP-ROP);对照组早产(出生胎龄≦34W或出生体重<2000g的早产儿)并与重度需治疗ROP患儿的同一新生儿重症监护病房(NICU)、出生胎龄、出生体重和矫正胎龄相匹配(出生体重相差不超过200g,出生胎龄相差不超过2周,矫正胎龄相差不超过2周)未发生ROP的患儿 

Inclusion criteria

Observation group: children with severe ROP requiring treatment; Control group: The premature who with infants gestational age ≦ 34w or premature birth weight <2000g and without ROP in the same neonatal intensive care unit (NICU) of observation group have the matched gestational age, birth weight and correct gestational age(birth weight difference is less than 200 g, birth gestational age difference less than 2 weeks, correct gestational age difference less than 2 weeks). 

排除标准:

1.家长要求终止研究或提前出院;2早产儿和患儿存在先天遗传代谢病;3研究过程中出现严重并发症(如脓毒症、坏死性小肠结肠炎、新生儿呼吸窘迫综合征,严重代谢紊乱,对照组发病等)或死亡;4研究对象的母亲在孕期有严重疾病史和服药史;5对照组在后续的复查中发病。 

Exclusion criteria:

1. Parents request to withdrew from the study or infants who have not completed ROP screening; 2. Congenital malformation genetic metabolic disease exists in preterm infants; 3. Severe complications (such as sepsis, necrotizing enterocolitis, neonatal respiratory distress syndrome, severe metabolic disorder, morbidity of the control group, etc.) or death occurred during the study; 4. The mother of the study subject has a history of serious diseases and medication during pregnancy; 5. The control group develop ROP in subsequent follow-up examinations. 

研究实施时间:

Study execute time:

From2019-02-01To 2020-05-01 

干预措施:

Interventions:

组别:

Case series

样本量:

120

Group:

Case series

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

测量指标:

Outcomes:

指标中文名:

小分子代谢物质

指标类型:

主要指标 

Outcome:

biomarkers of blood of retinopathy of prematurity (ROP)

Type:

Primary indicator 

测量时间点:

测量方法:

超高效液相色谱-串联质谱技术

Measure time point of outcome:

Measure method:

ultra performance liquid chromatography-mass spectrometry/mass spectrometry, UPLC-MS/MS

采集人体标本:

Collecting sample(s)
from participants:

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):

N/A

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

N/A

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):

2020年12月以论文形式公开

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

It will be published as a paper in December 2020

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:

病例记录表

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:

 2019-01-12
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