ChiCTR2400084895 版本V1.0 版本创建时间2024/05/27 17:52:36 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2400084895 

最近更新日期：

Date of Last Refreshed on：

2024-05-27 17:52:30 

注册时间：

Date of Registration：

2024-05-27 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

基于计划行为理论的早产产妇泌乳启动促进方案构建及应用

Public title：

Construction and application of the lactation initiation promotion program for premature parturient based on the theory of planned behavior

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于计划行为理论的早产产妇泌乳启动促进方案构建及应用

Scientific title：

Construction and application of the lactation initiation promotion program for premature parturient based on the theory of planned behavior

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：

徐怡婷 

研究负责人：

徐怡婷 

Applicant：

Xu Yiting 

Study leader：

Xu Yiting 

申请注册联系人电话：

Applicant telephone：

+86 158 2132 2758

研究负责人电话：

Study leader's telephone：

+86 158 2132 2758

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：

15821322758@163.com

研究负责人电子邮件：

Study leader's E-mail：

15821322758@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：

中国上海市浦东新区高科西路2699号

研究负责人通讯地址：

中国上海市浦东新区高科西路2699号

Applicant address：

No.2699 West Gaoke Road, Shanghai, China

Study leader's address：

No.2699 West Gaoke Road, Shanghai, 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：

同济大学附属妇产科医院

Applicant's institution：

Shanghai First Maternity and Infant Hospital, School of Medicine, Tongji University

研究负责人所在单位：

同济大学附属妇产科医院

Affiliation of the Leader：

Shanghai First Maternity and Infant Hospital, School of Medicine, Tongji University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

KS24241

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：

同济大学附属妇产科医院医学伦理委员会

Name of the ethic committee：

Ethics Committee. Obstetrics and Gynecology Hospital of Tongji University

伦理委员会批准日期：

Date of approved by ethic committee：

2024-04-11 00:00:00

伦理委员会联系人：

罗烨

Contact Name of the ethic committee：

Luo Ye

伦理委员会联系地址：

中国上海市浦东新区高科西路2699号

Contact Address of the ethic committee：

No.2699 West Gaoke Road, Shanghai, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 20261211

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：

同济大学附属妇产科医院

Primary sponsor：

Shanghai First Maternity and Infant Hospital, School of Medicine, Tongji University

研究实施负责（组长）单位地址：

中国上海市浦东新区高科西路2699号

Primary sponsor's address：

Shanghai First Maternity and Infant Hospital, School of Medicine, Tongji University

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

上海

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

同济大学附属妇产科医院

具体地址：

中国上海市浦东新区高科西路2699号

Institution
hospital：

Shanghai First Maternity and Infant Hospital, School of Medicine, Tongji University

Address：

No.2699 West Gaoke Road, Shanghai, China

经费或物资来源：

同济大学附属妇产科医院院级课题

Source(s) of funding：

Hospital-level project of obstetrics and Gynecology Hospital affiliated to Tongji University

Target disease：

breastfeeding

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

研究设计：

非随机对照试验 

Study design：

Non randomized control 

研究目的：

（1）通过循证护理学方法构建促进早产产妇泌乳启动方案初稿，基于实施科学基本框架形成计划行为理论的促进早产产妇泌乳启动方案终稿； （2）通过类实验研究评价促进早产产妇泌乳启动促进方案的临床应用效果。  

Objectives of Study：

(1) to construct the first draft of the initiation program of lactation promotion in preterm labor through evidence-based nursing method, and the final draft of the initiation program of lactation promotion in preterm labor based on the theory of planned behavior formed by implementing the scientific basic framework; (2) to evaluate the clinical effect of the initiation promotion program for promoting lactation in premature parturients by quasi-experimental study.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

① 新生儿出生孕周≥28周且＜37周； ② 产妇愿意进行母乳喂养； ③ 母婴分离； ④ 自愿参加本研究。

Inclusion criteria

1 the gestational age of the newborn was ≥28 weeks and < 37 weeks; 2 pregnant women are willing to breast-feed; 3 separation of mother and infant; 4 voluntary participation in this study.

排除标准：

① 患儿或产妇有母乳喂养禁忌症； ② 其他原因导致不能母乳喂养者。

Exclusion criteria：

1 the child or the puerpera has the breast-feeding contraindication; 2 other reasons lead to non-breastfeeding.

研究实施时间：

Study execute time：

从 From 2023-12-01 00:00:00至 To 2025-04-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-06-01 00:00:00 至 To 2024-12-31 00:00:00  

干预措施：

Interventions：

组别：

干预组

样本量：

58

Group：

Intervention Group

Sample size：

干预措施：

干预组在对照组基础上采用早产产妇泌乳启动促进方案进行干预。包括（1）产前：①成立围产期母乳喂养指导小组，要求小组成员熟悉和掌握母乳喂养知识和促进泌乳启动的技巧和方法，在产妇分娩前对夫妻双方进行健康宣教，在产后前3天指导母亲泌乳启动系列程序与方法；②制作母乳喂养宣教ppt，向母乳喂养家庭提供母乳采集的相关支持（采集技巧、储存方法、标识等）；③把早产儿母乳喂养的益处及促进产妇泌乳的方法告诉预期早产的孕妇及其家庭成员；④每周与产妇见面或通过微信沟通以修订和更新母乳喂养目标。（2）产后：①告知产妇每日将吸出的母乳按照要求送至新生儿科病房，患儿未开始喂养时，医生开初乳口腔护理医嘱，为患儿行初乳口腔护理，患儿可以开始喂养后立即应用母乳喂养。②实行首次挤奶负责制（由首次帮助产妇开奶的人员持续负责该产妇后期的泌乳监测及管理，若首次开奶人员为产科护士，则由研究者进行负责），并在产后3天内，每天通过至病房与产妇交流一次，询问其遇到的困难并帮助解决。③产妇身体条件允许的情况下，可以至新生儿科参与家庭式护理。家长可以通过家庭参与式护理掌握的照护技能包括但不限于七步洗手法，给新生儿称体重，粗略读取心率、呼吸、血氧值和观察新生儿脸色，换尿片和估算尿量，给新生儿穿脱衣，袋鼠抱，正确摆放新生儿体位，皮肤（含脐根部）护理，口腔护理，亲母抱喂母乳，经鼻饲管重力喂养，给新生儿洗澡，量体温等，可酌情进一步在护士照护下掌握喂药、吸痰等技能。

干预措施代码：

Intervention：

On the basis of the control group, the intervention group was given the lactation initiation promotion program. Including (1) prenatal: 1 set up a perinatal breastfeeding steering group, ask the group members to be familiar with and master breastfeeding knowledge and promote the start of lactation skills and methods, before the parturient woman gives birth to carry on the health education to the husband and wife both sides, instructs the mother lactation to start the series procedure and the method in the first 3 days after the parturition; 2 makes the breast-feeding education PPT, provide breast milk collection support to breastfeeding families (collection skills, storage methods, labeling, etc.) ; Inform expectant mothers and their family members about the benefits of breastfeeding for premature infants and ways to promote lactation; and meet with expectant mothers on a weekly basis or via wechat to revise and update breastfeeding targets. (2) postpartum: 1 inform the parturient to send the sucked breast milk to the neonatal ward every day according to the request. When the child does not start feeding, the doctor will prescribe the oral nursing of Colostrum for the child, and give the oral nursing of Colostrum for the child, infants can be breastfed immediately after they start feeding. 2 implementation of the first milking system (continuous monitoring and management of lactation in the later stages of the pregnancy by the first milker, or by the researcher if the first Milker is an obstetrical nurse) And in postpartum 3 days, every day through to the ward and maternal communication once, ask the difficulties encountered and help to solve. 3 parturient's body condition permits, may go to the newborn department to participate in the family type nursing. Care skills that parents can acquire through family-based participatory care include, but are not limited to, seven-step hand washing, weighing the newborn, reading heart rate, breathing, blood oxygen, and observing the newborn's complexion, changing diapers and estimating urine output, dressing and undressing the newborn, holding the kangaroo, positioning the newborn correctly, skin (including the navel) care, oral care, breast-feeding by the mother, gravity feeding through the nasogastric feeding tube, bathing the newborn, measure body temperature and so on, may further grasp under the nurse's care to feed medicine, suctioning and so on skill.

Intervention code：

组别：

对照组

样本量：

58

Group：

Control Group

Sample size：

干预措施：

常规护理措施

干预措施代码：

Intervention：

Routine nursing measures

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 上海 

市(区县)：

  

Country：

China 

Province：

Shanghai 

City：

 

单位(医院)：

同济大学附属妇产科医院 

单位级别：

三甲 

Institution
hospital：

Shanghai First Maternity and Infant Hospital, School of Medicine, Tongji University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

泌乳启动延迟发生率

指标类型：

主要指标

Outcome：

Incidence of delayed initiation of lactation

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

前3日泌乳量

指标类型：

主要指标

Outcome：

Milk production of 3 days

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

纯母乳喂养率

指标类型：

次要指标

Outcome：

Rate of exclusive breastfeeding

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：

乳汁

组织：

Sample Name：

human 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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 20 岁 years
最大 Max age 60 岁 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）：

无

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

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

Blinding：

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）：

无

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

None

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：

一旦获得参与同意，研究者立即发放一般资料调查表、汉化版 BAPT 问卷及母乳喂养知识问卷。根据随机数字表确定该名研究对象分组情况，若为干预组则组建微信群，群内包括产妇及其家属、产科护士长、儿科护长及研究者本人；对照组则添加微信。干预组在发放首份问卷后3天内进行首次床边干预，由研究者本人进行母乳喂养宣教。研究者每日查看病史，发现研究对象分娩后，干预组依照干预计划进行干预。研究者每日询问研究对象泌乳情况，计算每日泌乳量。在产妇出院时、产后42天、产后3个月通过问卷星发放汉化版BAPT 问卷、EPDS及母乳喂养知识问卷，并询问当时母乳喂养情况。

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

Once consent was obtained, the researchers sent out general information questionnaires, the Sinicization version of the BAPT questionnaire, and the breastfeeding knowledge questionnaire. According to the random number table, the study subjects were divided into groups, and some intervention groups were divided into wechat group, which included lying-in women and their family members, head nurses of obstetrics, head nurses of pediatrics and the researcher himself The control group added wechat. The first bedside intervention was carried out within 3 days after the first questionnaire was given to the intervention group. The medical history was checked every day and the intervention group was given the intervention according to the intervention plan after delivery. The researchers asked the subjects daily about their milk production and calculated their daily milk production. At the time of discharge, 42 days and 3 months after delivery, the Chinese version of BAPT questionnaire, EPDS and breast-feeding knowledge questionnaire were distributed to the parturients.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2024-05-27 17:52:30