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Association of functional components of breast milk with infant growth and development and intestinal health
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注册号:

Registration number:

ChiCTR2100052281 

最近更新日期:

Date of Last Refreshed on:

2022-04-25 

注册时间:

Date of Registration:

2021-10-24 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

母乳功能成分与婴幼儿生长发育及肠道健康的关联 

Public title:

Association of functional components of breast milk with infant growth and development and intestinal health 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

母乳功能成分与婴幼儿生长发育及肠道健康的关联 

Scientific title:

Association of functional components of breast milk with infant growth and development and intestinal health 

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:

赵艾 

研究负责人:

赵艾 

Applicant:

Zhao Ai 

Study leader:

Zhao Ai 

申请注册联系人电话:

Applicant telephone:

+86 10 62781788 

研究负责人电话:

Study leader's telephone:

+86 10 62781788 

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:

aizhao18@tsinghua.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

aizhao18@tsinghua.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:

北京市海淀区双清路30号 

研究负责人通讯地址:

北京市海淀区双清路30号 

Applicant address:

30 Shuangqing Road, Haidian District, Beijing 

Study leader's address:

30 Shuangqing Road, Haidian 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:

清华大学万科公共卫生与健康学院 

Applicant's institution:

Tsinghua University 

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:

20210126 

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:

清华大学医学伦理委员会 

Name of the ethic committee:

Tsinghua University Medical Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2021-09-22 

伦理委员会联系人:

朱艳东 

Contact Name of the ethic committee:

Zhu Yandong 

伦理委员会联系地址:

北京市海淀区双清路30号 

Contact Address of the ethic committee:

30 Shuangqing Road, Haidian 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:

its@tsinghua.edu.cn 

研究实施负责(组长)单位:

清华大学万科公共卫生与健康学院 

Primary sponsor:

Tsinghua University 

研究实施负责(组长)单位地址:

北京市海淀区双清路30号 

Primary sponsor's address:

30 Shuangqing Road, Haidian 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):

清华大学

具体地址:

海淀区双清路30号

Institution
hospital:

Tsinghua University

Address:

30 Shuangqing Road, Haidian District

经费或物资来源:

内蒙古乳业技术研究院有限责任公司;内蒙古伊利实业集团股份有限公司 

Source(s) of funding:

Inner Mongolia Dairy Technology Research Institute Co., Ltd.; Inner Mongolia Yili Industrial Group Co., Ltd. 

研究疾病:

N/A 

Target disease:

N/A 

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:

其它 

Study phase:

N/A 

研究目的:

1.通过考察婴儿喂养方式及检测母乳相关营养素水平,测量婴儿生长发育(包括:肠道菌群、体格发育、认知发育、免疫力)情况,分析母乳营养素对婴幼儿生长发育和肠道健康的关联,了解婴儿期代谢状况及其影响因素; 2.将母乳喂养的婴幼儿生长发育及肠道健康情况与混合喂养组(母乳与配方粉组混合喂养)或人工喂养组(配方奶粉组)进行比较,分析母乳核心营养素对婴儿生长发育及肠道健康的关联。 

Objectives of Study:

1. By examining infant feeding methods and detecting levels of nutrients related to breast milk, measuring infant growth and development (including: gut flora, physical development, cognitive development, immunity), analyzing the relationship of breast milk nutrients to infant growth and development and intestinal health, and understanding the metabolic status and influencing factors in infancy; 2. The growth and development and intestinal health of breastfed infants and young children were compared with the mixed feeding group (mixed feeding of breast milk and formula powder group) or the artificial feeding group (formulated milk powder group), to analyze the association of breast milk core nutrients on infant growth and development and gut health. 

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:

1.母亲: (1)无糖尿病等代谢性疾病; (2)无乙肝、HIV等传染性疾病; (3)无乳头凹陷等乳腺及乳房疾病。 2.婴儿: (1)单胎,足月产(孕周>37周); (2)出生Apagar评分>8分,且无遗传性、代谢性疾病; (3)未采用机械通气、抗生素等治疗。 

Inclusion criteria

1. Mother: (1) No metabolic diseases such as diabetes; (2) No infectious diseases such as hepatitis B and HIV; (3) No breast and breast diseases such as nipple depression. 2. Babies: (1) Singleton, term delivery (gestational age > 37 weeks); (2) Apagar score > 8 at birth, and no hereditary or metabolic disease; (3) Mechanical ventilation, antibiotics and other treatments were not used. 

排除标准:

1.母亲患有围产期抑郁等精神疾病,或无法良好配合研究者; 2.婴儿出生残疾者; 3.母婴发生重大疾病造成喂养或代谢障碍者(肿瘤、代谢疾病等); 4.自愿退出者。 

Exclusion criteria:

1. The mother suffers from mental illness such as perinatal depression, or is unable to cooperate well with the research; 2. Babies born with disabilities; 3. Those who suffer from major diseases of mother and child causing feeding or metabolic disorders (tumor, metabolic diseases, etc.); 4. Those who voluntarily withdraw. 

研究实施时间:

Study execute time:

From2021-11-30To 2022-11-30 

征募观察对象时间:

Recruiting time:

From2021-11-30To 2023-10-31 

干预措施:

Interventions:

组别:

人工喂养组

样本量:

80

Group:

artificial feeding group

Sample size:

干预措施:

配方奶粉

干预措施代码:

Intervention:

Formula milk

Intervention code:

组别:

混合喂养组

样本量:

80

Group:

mixed feeding group

Sample size:

干预措施:

母乳与配方粉组混合喂养

干预措施代码:

Intervention:

Mixed feeding of breast milk and formula group

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

甘肃 

市(区县):

兰州 

Country:

China 

Province:

Gansu 

City:

Lanzhou 

单位(医院):

兰州市妇幼保健院 

单位级别:

三级 

Institution
hospital:

Lanzhou Maternal and Child Health Hospital  

Level of the institution:

Tertiary 

国家:

中国 

省(直辖市):

辽宁 

市(区县):

沈阳 

Country:

China 

Province:

Liaoning 

City:

Shenyang 

单位(医院):

沈阳市妇幼保健院 

单位级别:

三级 

Institution
hospital:

Shenyang Maternal and Child Health Hospital  

Level of the institution:

Tertiary 

国家:

中国 

省(直辖市):

河北 

市(区县):

沧州 

Country:

China 

Province:

Hebei 

City:

Cangzhou 

单位(医院):

沧州市中西医结合医院 

单位级别:

三级 

Institution
hospital:

Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine  

Level of the institution:

Tertiary 

国家:

中国 

省(直辖市):

湖南 

市(区县):

郴州 

Country:

China 

Province:

Hu'nan 

City:

Chenzhou 

单位(医院):

湘南学院 

单位级别:

大学 

Institution
hospital:

Xiangnan Univeristy  

Level of the institution:

University 

测量指标:

Outcomes:

指标中文名:

母乳蛋白质

指标类型:

主要指标 

Outcome:

Breast milk protein

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

婴儿肠道菌群

指标类型:

主要指标 

Outcome:

Infant gut microbiota

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

母乳叶酸

指标类型:

主要指标 

Outcome:

Breast milk folic acid

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

母乳胆碱

指标类型:

主要指标 

Outcome:

Breast milk choline

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体格发育

指标类型:

主要指标 

Outcome:

Physical development

Type:

Primary 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

指标类型:

主要指标 

Outcome:

Cognitive development

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:

母乳

组织:

Sample Name:

Breast milk

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:

粪便

组织:

Sample Name:

Feces

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:

血液

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:

唾液

组织:

Sample Name:

Saliva

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 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):

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

None

盲法:

不涉及

Blinding:

NA

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):

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

NA

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:

使用调查问卷,建立CRF表。 由项目组研究员进行录入,建立电子数据库并进行数据管理

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

Questionnaires will be used to collect data, CRF will be applied. The data entry and management will be managed by the reseach team

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2021-10-24
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