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Effect of breastfeeding on brain development in premature infants and construction of human milk bank standardization system
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注册号:

Registration number:

ChiCTR1900027648 

最近更新日期:

Date of Last Refreshed on:

2019-11-22 

注册时间:

Date of Registration:

2019-11-22 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

母乳喂养对早中期早产儿大脑结构及功能发育的影响及人乳库标准化体系构建 

Public title:

Effect of breastfeeding on brain development in premature infants and construction of human milk bank standardization system 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

母乳喂养对早产儿脑发育的影响 

Scientific title:

Effect of breastfeeding on brain development in premature infants  

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:

杨蕊 

研究负责人:

徐鑫芬 

Applicant:

Rui Yang 

Study leader:

Xinfen Xu 

申请注册联系人电话:

Applicant telephone:

+86 13989843649 

研究负责人电话:

Study leader's telephone:

+86 13575738066 

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:

11718313@zju.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

xuxinf@zju.edu.cn 

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:

浙江省杭州市江干区凯旋路268号浙江大学华家池校区 

研究负责人通讯地址:

浙江省杭州市学士路1号 

Applicant address:

268 Kaixuan Road, Jianggan District, Hangzhou, Zhejiang, China 

Study leader's address:

1 Xueshi Road, Hangzhou, Zhejiang, China 

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:

浙江大学医学院 

Applicant's institution:

Zhejiang University School of Medicine 

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:

(2019)伦审科第(058)号 

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:

浙江大学医学院附属妇产科医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Women's Hospital School Of Medicine Zhejiang University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-11-15 

伦理委员会联系人:

朱小明 

Contact Name of the ethic committee:

Xiaoming Zhu 

伦理委员会联系地址:

浙江省杭州市学士路1号 

Contact Address of the ethic committee:

1 Xueshi Road, Hangzhou, Zhejiang, 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:

浙江大学医学院附属妇产科医院 

Primary sponsor:

Women's Hospital School Of Medicine Zhejiang University 

研究实施负责(组长)单位地址:

浙江省杭州市学士路1号 

Primary sponsor's address:

1 Xueshi Road, Hangzhou, Zhejiang, 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):

浙江省

市(区县):

杭州市

Country:

China

Province:

Zhejiang

City:

Hangzhou

单位(医院):

浙江大学医学院附属妇产科医院

具体地址:

浙江省杭州市学士路1号

Institution
hospital:

Women's Hospital School Of Medicine Zhejiang University

Address:

1 Xueshi Road, Hangzhou, Zhejiang, China

经费或物资来源:

浙江省卫建委 

Source(s) of funding:

Zhejiang Provincial Health Commission 

研究疾病:

早产 

Target disease:

preterm 

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:

探索性研究/预试验 

Study phase:

研究目的:

本课题拟通过观察母乳暴露与早产儿静息态脑功能网络连接,肠道微生态之间的相关性,并通过随访进一步探究母乳对早产儿生后6个月内脑功能的影响,揭示母乳喂养与早产儿脑发育的相关性。 

Objectives of Study:

This study aims to observe the correlation between breast milk exposure and resting brain function network in premature infants, the correlation between intestinal microecology, and further explore the effect of breast milk on brain function in preterm infants within 6 months after birth, revealing the correlation between bresatfeeding and brain development in premature infants. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

于2019年11月-2020年5月在本院出生;孕周为30-34周早产儿;体重在1500-3000g之间 

Inclusion criteria

Born in our hospital from November 2019 to May 2020; premature babies born in 30-34 weeks of gestation; weight between 1500-3000g 

排除标准:

家族内存在抑郁症或精神性疾病史;家族存在先天性大脑发育障碍史者;先天畸形、染色体异常者;中重度缺血缺氧性脑病,III、IV级脑室内出血(IVH),囊性脑室周围白质软化(PVL)者;先天性遗传代谢病、心功能不全、消化道畸形、内分泌异常者 

Exclusion criteria:

Family history of depression or mental illness; family history of congenital brain development disorder; congenital malformation, chromosomal abnormalities; moderate to severe hypoxic ischemic encephalopathy, grade III and IV intraventricular hemorrhage (IVH), periventricular leukomalacia(PVL); congenital genetic metabolic disease, cardiac insufficiency, digestive tract malformation, endocrine abnormalities 

研究实施时间:

Study execute time:

From2019-11-25To 2020-11-30 

干预措施:

Interventions:

组别:

不分组

样本量:

160

Group:

Case series

Sample size:

干预措施:

母乳暴露

干预措施代码:

Intervention:

breastfeeding

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

浙江大学医学院附属妇产科医院 

单位级别:

三级甲等 

Institution
hospital:

Women's Hospital School Of Medicine Zhejiang University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

脑功能连接

指标类型:

主要指标 

Outcome:

Brain function connection

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肠道微生物

指标类型:

次要指标 

Outcome:

Intestinal microbiome

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

认知发育水平

指标类型:

次要指标 

Outcome:

Cognitive developmental level

Type:

Secondary indicator 

测量时间点:

测量方法:

年龄与发育进程问卷(Ages and Stages Questionnaires,ASQ)

Measure time point of outcome:

Measure method:

Ages and Stages Questionnaires (ASQ)

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

粪便

组织:

Sample Name:

stool

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 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):

不随机

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

Not randomized

盲法:

N/A

Blinding:

N/A

原始数据公开时间:

The time of sharing IPD:

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11月30日,浙江大学医学院附属妇产科医院

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

November 30, 2020, Women's Hospital School Of Medicine Zhejiang 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:

病历记录表和Excel数据表

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

Case record form and Excel will be used

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-11-22
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