中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2500100744
最近更新日期： Date of Last Refreshed on：	2025-04-15 08:55:56
注册时间： Date of Registration：	2025-04-15 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	口腔运动干预联合三阶梯俯卧位通气在早产儿完全经口喂养中的研究
Public title：	Study on oral exercise intervention combined with three-step prone position ventilation in complete oral feeding of premature infants
注册题目简写：
English Acronym：	Study on oral exercise intervention combined with three-step prone position ventilation in complete oral feeding of premature infants
研究课题的正式科学名称：	口腔运动干预联合三阶梯俯卧位通气在早产儿完全经口喂养中的研究
Scientific title：	Study on oral exercise intervention combined with three-step prone position ventilation in complete oral feeding of 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：	雷雯媛	研究负责人：	雷雯媛
Applicant：	Lei Wenyuan	Study leader：	Lei Wenyuan
申请注册联系人电话： Applicant telephone：	+86 133 7702 2303	研究负责人电话： Study leader's telephone：	+86 772 266 2605
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：	124512419@qq.com	研究负责人电子邮件： Study leader's E-mail：	124512419@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：	柳州市城中区文昌路8号	研究负责人通讯地址：	广西柳州市文昌路8号
Applicant address：	No. 8 Wenchang Road, Chengzhong District, Liuzhou City, Guangxi	Study leader's address：	NO.8，Wenchang Road，Liuzhou，Guangxi，China，545006
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：	柳州市人民医院
Applicant's institution：	Liuzhou People's Hospital
研究负责人所在单位：	柳州市人民医院
Affiliation of the Leader：	Liuzhou people's hospital

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：	KY2024-164-01	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：	柳州市人民医院医学伦理委员会
Name of the ethic committee：	Research Ethical Committee of Liuzhou People's Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2024-12-14 00:00:00
伦理委员会联系人：	吴仕华
Contact Name of the ethic committee：	wushihua
伦理委员会联系地址：	广西柳州市文昌路8号
Contact Address of the ethic committee：	NO.8，Wenchang Road，Liuzhou，Guangxi，China，545006
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 772 266 2052	伦理委员会联系人邮箱： Contact email of the ethic committee：	392233973@qq.com

研究实施负责（组长）单位：

柳州市人民医院

Primary sponsor：

Liuzhou people's hospital

研究实施负责（组长）单位地址：

广西柳州市文昌路8号

Primary sponsor's address：

NO.8，Wenchang Road，Liuzhou，Guangxi，China，545006

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	广西壮族自治区	市(区县)：
Country：	China	Province：	Guangxi Zhuang Autonomous Region	City：
单位(医院)：	柳州市人民医院	具体地址：	广西柳州市文昌路8号
Institution hospital：	Liuzhou people's hospital	Address：	NO.8，Wenchang Road，Liuzhou，Guangxi，China，545006

经费或物资来源：

口腔运动干预联合三阶梯俯卧位通气在早产儿完全经口喂养中的研究

Source(s) of funding：

Study on Oral Movement Intervention Combined with Three Step Prone Ventilation in Premature Infants

研究疾病：

早产儿

Target disease：

preemy

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：

探索性研究/预试验

Study phase：

0

研究设计：

随机平行对照

Study design：

Parallel

研究目的：

通过口腔运动干预联合三阶梯俯卧位通气在早产儿完全经口喂养中的研究，提高早产儿的喂养进程，减少喂养不耐受的情况，有助于早产儿更好的生长发育。

Objectives of Study：

A study on the combination of oral exercise intervention and three-step prone ventilation in complete oral feeding of premature infants, aiming to improve the feeding process, reduce feeding intolerance, and promote better growth and development of premature 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：

Inclusion criteria

排除标准：

1.①非首次入院的早产儿； ②神经系统并发症如脑室内出血，脑室周白质软化等； ③先天性疾病如染色体或基因异常，神经系统畸形，复杂的先天性心脏病，先天性消化道畸形； ④重度窒息，机械通气治疗； ⑤具有严重感染； ⑥口腔黏膜损伤； ⑦需要特殊体位的疾病或治疗； ⑧家属放弃治疗或中途出院。

Exclusion criteria：

1. Premature infants who are not admitted for the first time; 2. Neurological complications such as intraventricular hemorrhage and periventricular white matter softening; 3. Congenital diseases such as chromosomal or genetic abnormalities, neurological malformations, complex congenital heart disease, and congenital gastrointestinal malformations; 4. Severe asphyxia, mechanical ventilation treatment; 5. Has severe infection; 6. Oral mucosal injury; 7. Diseases or treatments that require special positions; 8. Family members give up treatment or are discharged midway.

研究实施时间：

Study execute time：

从 From 2024-07-30 00:00:00至 To 2027-06-30 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2025-04-15 00:00:00 至 To 2026-12-31 00:00:00

干预措施：

Interventions：

组别：	儿科二病区早产儿喂养小组1	样本量：	80
Group：	Pediatric Ward 2 Preterm Infant Feeding Group 1	Sample size：	80
干预措施：	常规护理	干预措施代码：
Intervention：	Usual care	Intervention code：

组别：	儿科二病区早产儿喂养小组2	样本量：	80
Group：	Pediatric Ward 2 Preterm Infant Feeding Group 2	Sample size：	80
干预措施：	口腔运动干预联合三阶梯俯卧位通气	干预措施代码：
Intervention：	Oral exercise intervention combined with three-step prone ventilation	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	广西	市(区县)：
Country：	China	Province：	Guangxi Zhuang Autonomous Region	City：
单位(医院)：	柳州市人民医院	单位级别：	三级甲等
Institution hospital：	Liuzhou people's hospital	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	完全经口喂养成功率	指标类型：	主要指标
Outcome：	Complete oral feeding success rate	Type：	Primary indicator
测量时间点：	每天	测量方法：	评估干预后早产儿能否成功实现完全经口喂养，以及达到完全经口喂养的时间，衡量干预后早产儿的吸吮、吞咽能力。
Measure time point of outcome：	every day	Measure method：	Evaluate whether premature infants can successfully achieve complete oral feeding after intervention, as well as the time required to achieve complete oral feeding, and measure the sucking and swallowing abilities of premature infants after intervention.

指标中文名：	早产儿生长发育指标	指标类型：	主要指标
Outcome：	Growth and development indicators of premature infants	Type：	Primary indicator
测量时间点：		测量方法：	如体重、身长、头围等
Measure time point of outcome：		Measure method：	Such as weight, length, head circumference, etc

指标中文名：	日常喂养相关指标	指标类型：	主要指标
Outcome：	Indicators related to daily feeding	Type：	Primary indicator
测量时间点：		测量方法：	喂养频次、静脉营养液使用情况、大便性状及次数、小便性状及次数、是否出现腹胀、溢奶次数、呕吐次数等。
Measure time point of outcome：		Measure method：	Frequency of feeding, use of intravenous nutrient solution, stool quality and frequency, urine quality and frequency, abdominal distention, frequency of milk leakage, number of vomiting, etc.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	无	组织：
Sample Name：	NA	Tissue：
人体标本去向	其它	说明
Fate of sample：	0thers	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	1	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）：

早产儿按照入院时间进行随机分配

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

Premature infants are randomly assigned based on their admission time

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：	开放标签
Blinding：	Open-label study

是否共享原始数据： IPD sharing	否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）：	柳州市人民医院内网
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Liuzhou People's Hospital intranet
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：	（1）早产儿的出生体重数据来源：来源于医院出生记录和病历资料。测量方法：出生时由医护人员使用婴儿磅秤进行称量。可靠性：婴儿磅秤通常具有较高的精确度，且由专业人员进行操作，数据可靠性较高。（2）早产儿的胎龄数据来源：来源于医院出生记录和病历资料。测量方法：通过孕妇的末次月经日期和超声检查结果推算胎龄。可靠性：胎龄的推算方法较为成熟，但存在一定误差。超声检查结果相对可靠，但需考虑操作者的技术水平。（3）口腔运动干预次数数据来源：来源于口腔运动干预记录。测量方法：记录每次干预的时间、干预者、干预方法等。可靠性：通过详细记录干预过程，可以确保数据的准确性。但需注意干预者的操作规范性。（4）三阶梯俯卧位通气时间数据来源：来源于俯卧位通气记录。测量方法：记录每次通气的开始和结束时间，计算总通气时间。可靠性：通过精确记录通气时间，可以确保数据的准确性。但需注意操作者的规范操作。（5）早产儿完全经口喂养时间数据来源：来源于喂养记录。测量方法：记录早产儿从开始尝试经口喂养到完全经口喂养的时间。可靠性：通过详细记录喂养过程，可以确保数据的准确性。但需注意喂养方法的规范性和观察者的主观判断。（6）早产儿生长发育指标（如体重、身长、头围等）数据来源：来源于定期生长发育监测记录。测量方法：使用专业仪器（如婴儿秤、身高计、软尺等）进行测量。可靠性：专业仪器具有较高的精确度，且由专业人员进行操作，并记录在科研表格中，数据可靠性较高。（7）并发症发生率数据来源：来源于病历资料和并发症监测记录。测量方法：记录研究期间早产儿发生的并发症，如呼吸暂停、感染等。可靠性：通过详细记录并发症情况，可以确保数据的准确性。但需注意观察者的主观判断。在研究过程中，确保数据来源的准确性和测量方法的可靠性至关重要。通过规范地操作和详细地记录，可以提高研究的可信度。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	(1) Birth weight of premature infants Data source: sourced from hospital birth records and medical records. Measurement method: At birth, medical staff use a baby scale for weighing. Reliability: Baby scales typically have high accuracy and are operated by professionals, resulting in high data reliability. (2) The gestational age of premature infants Data source: sourced from hospital birth records and medical records. Measurement method: Calculate gestational age based on the last menstrual period date and ultrasound examination results of the pregnant woman. Reliability: The calculation method for gestational age is relatively mature, but there is a certain degree of error. The ultrasound examination results are relatively reliable, but the operator's technical level needs to be considered. (3) Number of Oral Movement Interventions Data source: sourced from oral exercise intervention records. Measurement method: Record the time, intervener, intervention method, etc. of each intervention. Reliability: By recording the intervention process in detail, the accuracy of the data can be ensured. However, attention should be paid to the operational norms of the interventionist. (4) Three step prone position ventilation time Data source: sourced from prone position ventilation records. Measurement method: Record the start and end time of each ventilation and calculate the total ventilation time. Reliability: By accurately recording ventilation time, the accuracy of data can be ensured. But attention should be paid to the operator's standardized operation. (5) Complete oral feeding time for premature infants Data source: sourced from feeding records. Measurement method: Record the time from attempting oral feeding to complete oral feeding in premature infants. Reliability: By recording the feeding process in detail, the accuracy of the data can be ensured. However, attention should be paid to the standardization of feeding methods and the subjective judgment of observers. (6) Growth and development indicators of premature infants (such as weight, length, head circumference, etc.) Data source: sourced from regular growth and development monitoring records. Measurement method: Use professional instruments (such as baby scales, height meters, tape measures, etc.) for measurement. Reliability: Professional instruments have high accuracy and are operated by professionals and recorded in scientific research tables, resulting in high data reliability. (7) Incidence of complications Data source: sourced from medical records and complication monitoring records. Measurement method: Record the complications that occur in premature infants during the study period, such as respiratory pauses, infections, etc. Reliability: By detailed recording of complications, the accuracy of data can be ensured. But attention should be paid to the subjective judgment of the observer. Ensuring the accuracy of data sources and the reliability of measurement methods is crucial in the research process. By operating in a standardized manner and recording in detail, the credibility of research can be improved.
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2025-04-15 08:55:48