Today is 2020-03-30

A randomized controlled trial for comparing feeding preterm infants fresh versus frozen mother's own milk in the NICU
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注册号:

Registration number:

ChiCTR1900020577 

最近更新日期:

Date of Last Refreshed on:

2019-01-09 

注册时间:

Date of Registration:

2019-01-09 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

NICU中新鲜与冷冻亲母母乳喂养早产儿的随机对照研究 

Public title:

A randomized controlled trial for comparing feeding preterm infants fresh versus frozen mother's own milk in the NICU 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

NICU中新鲜与冰冻亲母乳喂养<30周早产儿的随机对照研究 

Scientific title:

A randomized controlled trial for comparing feeding preterm infants <30 weeks' gestation fresh versus frozen mother's own milk in the NICU 

研究课题代号(代码):

Study subject ID:

FBM 

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:

孙慧清 

研究负责人:

李树锦 

Applicant:

Huiqing Sun 

Study leader:

Shoo Lee 

申请注册联系人电话:

Applicant telephone:

+86 0371 85515913 

研究负责人电话:

Study leader's telephone:

+1 416 586-4800 ext 6370 

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:

s_huiqing@sina.com 

研究负责人电子邮件:

Study leader's E-mail:

Shoo.Lee@sinaihealthsystem.ca 

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:

河南省郑州市龙湖外环路33号 

研究负责人通讯地址:

多伦多大学600号 

Applicant address:

33 Waihuan Road, Longhu District, Zhengzhou, He'nan, China 

Study leader's address:

600 University Avenue, Room 19-2310, Toronto, Ontario M5G 1X5 

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:

郑州大学附属儿童医院 

Applicant's institution:

Children's Hospital affiliated to Zhengzhou 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:

2018042701 

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:

郑州大学附属儿童医院临床科研伦理委员会 

Name of the ethic committee:

Research Ethics Committee of Children’s Hospital affiliated to Zhengzhou University for Clinical Research 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

和东阳 

Contact Name of the ethic committee:

Dongyang He 

伦理委员会联系地址:

河南省郑州市龙湖外环路33号 

Contact Address of the ethic committee:

33 Waihuan Road, Longhu District, Zhengzhou, He'nan, 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:

中国新生儿协作网 

Primary sponsor:

Chinese Neonatal Network 

研究实施负责(组长)单位地址:

上海儿童医学中心 

Primary sponsor's address:

Shanghai Children Medical Center 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

河南

市(区县):

郑州

Country:

China

Province:

He'nan

City:

Zhengzhou

单位(医院):

郑州大学附属儿童医院

具体地址:

河南省郑州市龙湖外环路33号

Institution
hospital:

Children's Hospital affiliated to Zhengzhou University

Address:

33 Waihuan Road, Longhu District, Zhengzhou, He'nan, China

经费或物资来源:

中国新生儿协作网 

Source(s) of funding:

Chinese Neonatal Network 

研究疾病:

新生儿坏死性小肠结肠炎和死亡率 

Target disease:

Neonatal necrotizing enterocolitis and motality 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

坏死性小肠结肠炎(NEC)是出生胎龄<30周的早产儿死亡的主要原因, 对于母乳喂养的早产儿,NEC的发病率比配方奶喂养的发病率低,目前我国多数早产儿是冷冻母乳或母乳巴氏消毒后喂养,但冷冻或巴氏灭菌会使母乳中有益的生物活性成分失活,降低有效性。 我们的初步研究表明,每天喂养一次新鲜亲母母乳安全可行,有降低NEC发生的趋势。 为了进一步探讨新鲜母乳喂养比冷冻母乳喂养对早产儿的有益性,采用多中心前瞻性随机对照试验进行每天2次的新鲜母乳喂养,以评估新鲜母乳喂养对早产儿发病率和病死率的影响。 

Objectives of Study:

Necrotizing enterocolitis (NEC) is the leading cause of death among preterm infants born at <30 weeks’ gestation. The incidence of NEC is lower when infants are fed human milk, but freezing or pasteurization deactivates beneficial bioactive components of human milk. Our pilot study showed that one feed of fresh mother’s own milk per day was safe, feasible, and may reduce morbidity in preterm infants. To further evaluate the benefits of fresh human milk, a randomized controlled trial is needed. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1.出生体重<30周的早产儿 2.未接受配方奶喂养 3.入住参与研究的28家三级医院NICU的早产儿 4.患儿父母同意参与研究 5.患儿母亲同意每天至少送2次新鲜母乳喂养,每周7天连续不间断,直至纠正胎龄32周 

Inclusion criteria

1. Born at <30 weeks gestation; 2. Who never received infant formula; 3. Admitted to one of the 28 participating tertiary NICUs in China; 4. Have parents who consent to the study; 5. Have mothers who are willing to providing at least 2 feeds of fresh milk a day, 7 days a week until the infant is 32 weeks corrected age. 

排除标准:

1.患儿有先天异常或接受姑息治疗的早产儿 2.患儿母亲患有疾病不能提供新鲜母乳喂养 3.患儿母亲每天不能提供至少2次的新鲜母乳喂养 4.患儿有先天巨细胞病毒感染 5.母亲的血液化验CMV-IgM (+), 或 CMV-DNA (+) 6.患儿父母不同意参与研究 

Exclusion criteria:

1. Infants with major congenital anomalies or receiving palliative care; 2. Infants with mothers who are too ill to provide fresh human milk in the first week after birth; 3. 1nfants with mothers who are unable to provide at least 2 feeds of fresh milk a day; 4. Infants with congenital Cytomegalic virus (CMV) infection; 5. Infants whose mothers have blood CMV-IgM (+), or CMV-DNA (+); 6. Infants with parents who are unwilling to consent. 

研究实施时间:

Study execute time:

From2019-01-01To 2021-06-30 

干预措施:

Interventions:

组别:

Group 2

样本量:

1549

Group:

Group 2

Sample size:

干预措施:

新鲜亲母母乳

干预措施代码:

Intervention:

Fresh Breast Milk

Intervention code:

组别:

Group 1

样本量:

1549

Group:

Group 1

Sample size:

干预措施:

冷冻亲母母乳

干预措施代码:

Intervention:

previously frozen milk

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

河南省 

市(区县):

郑州市 

Country:

China 

Province:

Henan 

City:

Zhengzhou 

单位(医院):

郑州大学附属儿童医院 

单位级别:

三甲医院 

Institution
hospital:

Children's Hospital affiliated to Zhengzhou University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

上海市 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

Shanghai 

单位(医院):

复旦大学附属儿科医院 

单位级别:

三甲医院 

Institution
hospital:

Children’s Hospital of Fudan University  

Level of the institution:

Tertiary A Hospital 

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):

南京妇幼保健院 

单位级别:

三甲医院 

Institution
hospital:

Nanjing Maternity and Child Health Care Hospital  

Level of the institution:

Tertiary A Hospital 

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):

南京医科大学附属儿童医院 

单位级别:

三甲医院 

Institution
hospital:

Children’s Hospital of Nanjing Medical University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

贵州省 

市(区县):

贵阳市 

Country:

China 

Province:

Guizhou 

City:

Guiyang 

单位(医院):

贵州省妇幼保健院 

单位级别:

三甲医院 

Institution
hospital:

Guizhou Maternity and Child Health Care Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghgai 

City:

Shanghai 

单位(医院):

上海第一妇婴保健院 

单位级别:

三甲医院 

Institution
hospital:

Shanghai First Maternity and Infant Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

湖北省 

市(区县):

武汉 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

湖北省妇幼保健院 

单位级别:

三甲医院 

Institution
hospital:

The Women and Children's Health-Care Hospital of Hubei province  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

广东省 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

广州妇女儿童中心 

单位级别:

三甲医院 

Institution
hospital:

Guangzhou Women and Children’s Medical Center  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

陕西省 

市(区县):

西安 

Country:

China 

Province:

Shanxi 

City:

Xian 

单位(医院):

西北妇女儿童医院 

单位级别:

三甲医院 

Institution
hospital:

Northwest Women and Children Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

甘肃省 

市(区县):

兰州 

Country:

China 

Province:

Gansu 

City:

Lanzhoiu 

单位(医院):

甘肃妇幼保健院 

单位级别:

三甲医院 

Institution
hospital:

Gansu Maternity and Child Care Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

广西壮族自治区 

市(区县):

南宁 

Country:

China 

Province:

Guangxi Zhuang Autonomous Region 

City:

Nanning 

单位(医院):

广西壮族自治区妇幼保健院 

单位级别:

三甲医院 

Institution
hospital:

Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

新疆维吾尔自治区 

市(区县):

维吾尔 

Country:

China 

Province:

Xinjiang Uygur Autonomous Region 

City:

Uiger 

单位(医院):

新疆维吾尔人民医院 

单位级别:

三甲医院 

Institution
hospital:

Xinjiang Uiger Municipal people’s Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

江苏省 

市(区县):

苏州市 

Country:

China 

Province:

Jiangsu 

City:

Suzhou 

单位(医院):

苏州大学附属儿童医院 

单位级别:

三甲医院 

Institution
hospital:

Children’s Hospital of Soochow University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

福建省 

市(区县):

厦门 

Country:

China 

Province:

Fujian 

City:

Xiamen 

单位(医院):

厦门儿童医院 

单位级别:

三甲医院 

Institution
hospital:

Xiamen Children’s Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

浙江省 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

浙江大学附属妇产医院 

单位级别:

三甲医院 

Institution
hospital:

Women’s Hospital School of Medicine Zhejiang University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

山东省 

市(区县):

济南市 

Country:

China 

Province:

Shandong 

City:

Jinan 

单位(医院):

山东大学附属齐鲁医院 

单位级别:

三甲医院 

Institution
hospital:

Qilu Children’s Hospital of Shandong University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

浙江省 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

浙江大学附属儿童医院 

单位级别:

三甲医院 

Institution
hospital:

Children’s Hospital School of Medicine Zhejiang University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

陕西省 

市(区县):

西安 

Country:

China 

Province:

Shanxi 

City:

Xian 

单位(医院):

陕西省人民医院 

单位级别:

Institution
hospital:

Shaanxi Provincial People’s Hospital  

Level of the institution:

国家:

中国 

省(直辖市):

山西省 

市(区县):

太原 

Country:

China 

Province:

Shaanxi 

City:

Taiyuan 

单位(医院):

山西省儿童医院 

单位级别:

三甲医院 

Institution
hospital:

Shanxi Children’s Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

安徽省 

市(区县):

合肥市 

Country:

China 

Province:

Anhui 

City:

Hefei 

单位(医院):

安徽省立医院 

单位级别:

三甲医院 

Institution
hospital:

Anhui Provincial Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

上海 

Country:

China 

Province:

Shanghai 

City:

Shanghai 

单位(医院):

复旦大学附属妇产医院 

单位级别:

三甲医院 

Institution
hospital:

Obstetrics and Gynecology, Hospital of Fudan University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

福建省 

市(区县):

厦门 

Country:

China 

Province:

FuJian 

City:

Xiamen 

单位(医院):

厦门弘爱医院 

单位级别:

三甲医院 

Institution
hospital:

Xianmen Humanity Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

北京 

Country:

China 

Province:

Beijing 

City:

Beijing 

单位(医院):

首都儿科研究所附属儿童医院 

单位级别:

三甲医院 

Institution
hospital:

Children's Hospital of Capital Institute of Pediatrics  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

新疆 

市(区县):

维吾尔 

Country:

China 

Province:

Xinjiang Uygur Autonomous Region 

City:

Uiger 

单位(医院):

新疆医科大学第一附属医院 

单位级别:

三甲医院 

Institution
hospital:

First Affiliated Hospital of Xinjiang Medical University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

江西省 

市(区县):

南昌 

Country:

China 

Province:

Jiangxi 

City:

Nanchang 

单位(医院):

江西省儿童医院 

单位级别:

三甲医院 

Institution
hospital:

Jiangxi Children’s Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

上海 

Country:

China 

Province:

Shanghai 

City:

Shanghai 

单位(医院):

上海交通大学附属第一人民医院 

单位级别:

三甲医院 

Institution
hospital:

Shanghai General Hospital, Shanghai Jiaotong University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

广东省 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

广东妇幼保健院 

单位级别:

三甲医院 

Institution
hospital:

Guangdong Women and Children Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

广东省 

市(区县):

深圳 

Country:

China 

Province:

Guangdong 

City:

Shenzhen 

单位(医院):

深圳妇幼保健院 

单位级别:

三甲医院 

Institution
hospital:

Shenzhen Maternity and Child Healthcare Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

澳大利亚 

省(直辖市):

西澳大利亚 

市(区县):

珀斯 

Country:

Australia 

Province:

Western Australia 

City:

Perth 

单位(医院):

西澳大学 

单位级别:

大学 

Institution
hospital:

The University of Western Australia  

Level of the institution:

University 

国家:

加拿大 

省(直辖市):

安大略省 

市(区县):

多伦多 

Country:

Canada 

Province:

Ontario 

City:

Toronto 

单位(医院):

西奈山医院 

单位级别:

三甲医院 

Institution
hospital:

Mount Sinai Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

出院前病死率或2期以上坏死性小肠结肠炎的发病率

指标类型:

主要指标 

Outcome:

composite of mortality or necrotizing enterocolitis ≥ stage 2 before discharge

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

出院前死亡率

指标类型:

次要指标 

Outcome:

mortality before discharge

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

2期以上NEC

指标类型:

次要指标 

Outcome:

NEC ≥ stage 2

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

需要手术治疗的NEC

指标类型:

次要指标 

Outcome:

NEC needing surgery

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

晚发败血症

指标类型:

次要指标 

Outcome:

late-onset sepsis

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

早产儿视网膜病和需要手术治疗的视网膜病

指标类型:

次要指标 

Outcome:

retinopathy of prematurity (ROP) and ROP requirement

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

支气管肺发育不良

指标类型:

次要指标 

Outcome:

bronchopulmonary dysplasia

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体重、身长和头围的变化

指标类型:

次要指标 

Outcome:

change in weight, length, and head circumference;

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

达全经肠喂养时间

指标类型:

次要指标 

Outcome:

time to full enteral feeds

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

不良事件发生的次数,包括喂养错误

指标类型:

次要指标 

Outcome:

number and type of critical incident reports, including feeding errors

Type:

Secondary 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:

Breast Milk

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 years

性别:

女性

Gender:

Female

随机方法(请说明由何人用什么方法产生随机序列):

根据各家NICU 进行分层区组随机化,把患儿随机分配到对照组或新鲜母乳组,随机分配方案是按顺序编码、不透光、密封的信封的方法,应用随机分组软件产生分组顺序编码。

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

The statistician will create an allocation scheme for each site that will be concealed using sequentially numbered opaque sealed envelopes held by a research coordinator not involved with the study

盲法:

未说明

Blinding:

Not stated

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):

试验未开始,无原始数据

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

We have no IPD yet

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:

该研究采用病例记录表收集2019年1月1日至2020年12月31日关于母婴特征的数据,包括人口统计学,风险因素,分娩并发症,疾病严重程度评分,婴儿并发症,体重,生长和每日喂养方法,包括益生菌。所有信息都将收集在数据表格中,这些数据表格将输入到加密的Excel文件数据库中以供后续分析。所有数据都将被去除识别,我们将在汇总数据时使用患者编号而不是名称。数据访问将遵守隐私法规,所有数据将由研究专家委员会保存,以保护患者的隐私。上海复旦大学附属儿科医院研究所为母乳研究协调中心,协调中心将存储所有的研究数据和进行完整的数据分析。郑州大学附属儿童医院负责临床研究注册、各家医院伦理审查报告收集及研究数据的收集。

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

We will collect data from January 1, 2019 to December 31, 2020 on maternal and infant characteristics including demographics, risk factors, delivery complications, illness severity scores, infant complications, weight, growth, and daily feeding practices, including probiotics. All information will be collected on data forms that will be entered into an encrypted excel file database for subsequent analysis. Study-specific variables will include compliance with the fresh milk protocol, the number and volume of fresh milk feeds provided to study infants on each day, and the response of the infant following the feed (Appendix 4). All data will be de-identified, and we will use patient numbers instead of names when summarizing data. Data access will comply with privacy regulations, and all data will be kept by a specialist to protect the patient’s privacy. The Research Institute of Children’s Hospital of Fudan University in Shanghai, China will host the coordinating center for the Fresh Milk study. The coordinating center will store all the study data and complete data analysis. Dr. Huiqing Sun from the Children’s Hospital affiliated to Zhengzhou University will be the Principal Investigator of the study and will be responsible for registering, receiving ethical approval, and notifying and receiving approval for changes to the study from the regulatory bodies. The study has received ethical approval from the ethics committee of the Children’s Hospital affiliated to Zhengzhou University for Clinical Research (REB #2018042701, Appendix 3). The study will be registered in the clinicaltrials.gov registry. To ensure ethical standards are met, we will obtain informed consent from each participating parent before enrollment and will respect the parents’ decision to join or leave the study at any time. Furthermore, we will use an incident reporting system that will be completed within 24 of an incident and will include a formal written report to guarantee patient’s safety. Finally, we will obtain parents’ written approval for publishing their names or pictures on the research update in addition to following the data privacy procedures described above.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-01-09
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