ChiCTR2500115864 版本V1.0 版本创建时间2025/12/31 17:31:11 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：

ChiCTR2500115864 

最近更新日期：

Date of Last Refreshed on：

2025-12-31 17:30:24 

注册时间：

Date of Registration：

2025-12-31 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

基于信息化平台的家庭-县级医院二级联动出院后早产儿护理模式的构建及初步应用研究

Public title：

Construction and Preliminary Application Study of a Family-County Hospital Secondary Linked Post-Discharge Care Model for Premature Infants Based on an Information Platform

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于信息化平台的家庭-县级医院二级联动出院后早产儿护理模式的构建及初步应用研究

Scientific title：

Construction and Preliminary Application Study of a Family-County Hospital Secondary Linked Post-Discharge Care Model for Premature Infants Based on an Information Platform

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：

孙晓函 

研究负责人：

孙晓函 

Applicant：

Sun Xiaohan 

Study leader：

Sun Xiaohan 

申请注册联系人电话：

Applicant telephone：

+86 158 5766 2192

研究负责人电话：

Study leader's telephone：

+86 158 5766 2192

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：

532334174@qq.com

研究负责人电子邮件：

Study leader's E-mail：

532334174@qq.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：

浙江省临海市大洋街道学浦路298号

研究负责人通讯地址：

浙江省临海市大洋街道学浦路298号

Applicant address：

No. 298, Xuepu Road, Dayang Street, Linhai City, Zhejiang Province

Study leader's address：

No. 298, Xuepu Road, Dayang Street, Linhai City, Zhejiang Province

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：

临海市妇幼保健院

Applicant's institution：

Linhai Maternal and Child Health Hospital

研究负责人所在单位：

临海市妇幼保健院

Affiliation of the Leader：

Linhai Maternal and Child Health Hospital

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：

YJLFBY202501

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：

临海市妇幼保健院伦理委员会

Name of the ethic committee：

Linhai Maternal and Child Health Hospital Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

2025-11-14 00:00:00

伦理委员会联系人：

朱士土

Contact Name of the ethic committee：

Zhu Shitu

伦理委员会联系地址：

浙江省临海市大洋街道学浦路298号

Contact Address of the ethic committee：

No. 298, Xuepu Road, Dayang Street, Linhai City, Zhejiang Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 150 6865 5756

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：

临海市妇幼保健院

Primary sponsor：

Linhai Maternal and Child Health Hospital

研究实施负责（组长）单位地址：

浙江省临海市大洋街道学浦路298号

Primary sponsor's address：

No. 298, Xuepu Road, Dayang Street, Linhai City, Zhejiang Province

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

市(区县)：

Country：

China

Province：

Zhejiang

City：

单位(医院)：

临海市妇幼保健院

具体地址：

浙江省临海市大洋街道学浦路298号

Institution
hospital：

Linhai Maternal and Child Health Hospital

Address：

No. 298, Xuepu Road, Dayang Street, Linhai City, Zhejiang Province

经费或物资来源：

自筹

Source(s) of funding：

self-financed

Target disease：

Premature baby

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：

随机平行对照 

Study design：

Parallel 

研究目的：

1. 构建适配基层的基于信息化平台的联动护理模式 以“基层可落地、医护易操作、家庭好上手”为核心原则，构建基于信息化平台的家庭-县级医院二级联动护理模式。明确模式核心架构，涵盖县级医院医护和早产儿家庭双方的功能分工与协同机制；设计适配基层的信息化平台核心模块，整合早产儿电子健康档案、日常照护数据上传、个性化护理指导、双向沟通互动、风险预警提示等核心功能，兼顾基层医院技术条件与家庭数字素养，确保模式的基层适配性与实操性。 2.验证该模式应用成效并形成可推广经验 通过初步应用开展随机对照研究，对比试验组与对照组在早产儿生长发育指标（身高、体重、神经发育等）、家长照护能力评分、再入院率等方面的差异，科学验证该二级联动护理模式的实用性与有效性。同时总结模式构建和应用中的问题与改进方案，形成适配县级医院推广的实操经验，为同类基层医院开展早产儿出院后护理工作提供参考。  

Objectives of Study：

1. Develop a community-adapted, information-based collaborative care model Focusing on the core principles of "practical for the community, easy for medical staff to operate, user-friendly for families," develop a family–county hospital two-tier collaborative care model based on an information platform. Clarify the core framework of the model, covering the functional division and coordination mechanisms between county hospital medical staff and families of preterm infants. Design core modules of the information platform suitable for community use, integrating key functions such as electronic health records for preterm infants, daily care data uploads, personalized care guidance, two-way communication and interaction, and risk warning alerts, while taking into account the technical conditions of community hospitals and the digital literacy of families, ensuring the model’s suitability and practicality for community settings. 2. Validate the effectiveness of the model and generate replicable experience Conduct a preliminary randomized controlled study to compare differences between the experimental group and the control group in preterm infants’ growth and development indicators (height, weight, neurodevelopment, etc.), parents’ caregiving ability scores, and readmission rates, scientifically verifying the practicality and effectiveness of this two-tier collaborative care model. At the same time, summarize issues and improvement solutions encountered during the model’s development and application to form practical experiences that can be promoted in county-level hospitals, providing a reference for similar community hospitals in conducting post-discharge care for preterm infants.

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.胎龄确认以新生儿科记录的末次月经日期结合超声孕周校正，确保胎龄≥32 周且<37 周； 2.出生时 Apgar 评分≥7 分（5 分钟）； 3.住院期间完成从管饲到经口喂养过渡，出院时经口喂养量≥80% 每日需求量； 4.家庭居住固定，具备智能手机接收信息能力，至少有 1 名主要照护者年龄≥20 岁且具备基本读写能力。

Inclusion criteria

1. Gestational age is confirmed based on the date of the last menstrual period recorded by the neonatology department, adjusted with ultrasound gestational age, ensuring a gestational age >=32 weeks and <37 weeks; 2. Apgar score at birth >=7 (at 5 minutes); 3. During hospitalization, the transition from tube feeding to oral feeding is completed, with oral intake >=80% of daily requirements at discharge; 4. The family has a fixed residence, has the ability to receive information via smartphone, and has at least one primary caregiver aged >=20 years with basic literacy skills.

排除标准：

1.机械通气超过 48 小时史； 2.遗传代谢病筛查（如串联质谱）异常者； 3.母亲孕期有酗酒、吸毒史或患严重妊娠期疾病（如子痫前期、糖尿病酮症酸中毒）； 4.家庭存在社会福利机构介入风险（如虐待、遗弃史）

Exclusion criteria：

1. History of mechanical ventilation for more than 48 hours; 2. Abnormal findings in genetic metabolic disease screening (such as tandem mass spectrometry); 3. Mother has a history of alcohol or drug abuse during pregnancy, or suffers from severe pregnancy-related illnesses (such as preeclampsia or diabetic ketoacidosis); 4. The family has a risk of intervention from social welfare agencies (such as history of abuse or neglect).

研究实施时间：

Study execute time：

从 From 2025-11-14 00:00:00至 To 2026-11-13 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-01-01 00:00:00 至 To 2026-07-31 00:00:00  

干预措施：

Interventions：

组别：

试验组

样本量：

47

Group：

Experimental group

Sample size：

干预措施：

试验组使用本研究构建的基于信息化平台的家庭-县级医院二级联动出院后早产儿护理模式。

干预措施代码：

Intervention：

The experimental group used the post-discharge care model for premature infants, based on an information platform, linking families with county-level hospitals constructed in this study.

Intervention code：

组别：

对照组

样本量：

47

Group：

Control group

Sample size：

干预措施：

对照组接受常规干预：出院前系统化宣教（1.5h）+出院医嘱解读+《早产儿居家护理手册》+出院后1周电话随访+每4周儿保门诊随访（体格测量、发育筛查、喂养指导）+微信群科普支持（每周2次）+24h急诊绿色通道。

干预措施代码：

Intervention：

The control group received conventional interventions: systematic education before discharge (1.5 hours), explanation of discharge instructions, 'Home Care Manual for Preterm Infants,' telephone follow-up one week after discharge, pediatric outpatient follow-up every 4 weeks (physical measurements, developmental screening, feeding guidance), educational support via WeChat group (twice a week), and a 24-hour emergency green channel.

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)：

  

Country：

China 

Province：

Zhejiang 

City：

 

单位(医院)：

临海市妇幼保健院 

单位级别：

二甲 

Institution
hospital：

Linhai Maternal and Child Health Hospital

Level of the institution：

Secondary

测量指标：

Outcomes：

指标中文名：

体重

指标类型：

主要指标

Outcome：

Body weight

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

头围

指标类型：

主要指标

Outcome：

Head circumference

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

身长

指标类型：

主要指标

Outcome：

Body length

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

神经发育水平

指标类型：

次要指标

Outcome：

Neurodevelopmental level

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：

无

组织：

Sample Name：

None

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 岁 years
最大 Max age 0 岁 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）：

该研究采用随机数字表法产生随机序列，由课题组未参与干预方案实施的独立成员执行。

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

The study used a random number table to generate a random sequence, which was executed by independent members of the research team who were not involved in the implementation of the intervention protocol.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

1.分组由不参与干预、评估的独立研究者操作，结果密封隐藏（如装密封信封、密码文档），不提前告知干预人员和研究对象； 2.给早产儿的编号仅用于分组，不泄露给干预、评估人员； 3.两组干预在不同时间进行，避免相互沾染； 4.干预人员只知道自己负责的干预方案，不清楚另一组情况，直到干预启动才获取对应对象的分组结果。

Blinding：

1. Grouping is conducted by independent researchers who do not participate in the intervention or assessment, with results sealed and concealed (e.g., in sealed envelopes or password-protected documents), and not disclosed in advance to the intervention personnel and study participants; 2. The numbers assigned to preterm infants are only used for grouping and are not disclosed to the intervention or assessment personnel; 3. Interventions for the two groups are conducted at different times to avoid cross-contamination; 4. Intervention personnel only know the intervention plan they are responsible for and are unaware of the other group's situation, only obtaining the corresponding subjects' group results once the intervention begins.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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：

无

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

None

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：

  2025-12-31 17:30:24