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：	ChiCTR2500095343
最近更新日期： Date of Last Refreshed on：	2025-01-06 15:26:06
注册时间： Date of Registration：	2025-01-06 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	不同胎龄足月儿扰动系数值的建立及相关性研究
Public title：	Establishment and correlation of perturbation coefficient values in full-term infants of different gestational ages
注册题目简写：
English Acronym：
研究课题的正式科学名称：	不同胎龄足月儿扰动系数值的建立及相关性研究
Scientific title：	Establishment and correlation of perturbation coefficient values in full-term infants of different gestational ages
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：	赵梦茹	研究负责人：	赵梦茹
Applicant：	Zhao Mengru	Study leader：	Zhao Mengru
申请注册联系人电话： Applicant telephone：	+86 13577125942	研究负责人电话： Study leader's telephone：	+86 871 64101603
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：	468044364@qq.com	研究负责人电子邮件： Study leader's E-mail：	468044364@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：	云南省昆明市西山区兰亭上锦小区二期4单元606号	研究负责人通讯地址：	中国·云南昆明滇缅大道374号
Applicant address：	No. 606, Unit 4, Phase II, Lanting Shangjin Community, Xishan District, Kunming , Yunnan Province	Study leader's address：	No.374 Dianmian Road Kunming P.R. 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：	昆明医科大学第二附属医院
Applicant's institution：	The Second Affiliated Hospital of Kunming Medical University
研究负责人所在单位：	昆明医科大学第二附属医院
Affiliation of the Leader：	The second Affiliated Hospital of Kunming Medical 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：	审-PJ-科-2024-32	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：	昆明医科大学第二附属医院医学伦理委员会
Name of the ethic committee：	The Medical Ethics Committee 's Attendance Form of the Second Affiliated Hospital of Kunming Medical University
伦理委员会批准日期： Date of approved by ethic committee：	2024-02-02 00:00:00
伦理委员会联系人：	王政
Contact Name of the ethic committee：	Wang Zheng
伦理委员会联系地址：	中国·云南昆明滇缅大道374号
Contact Address of the ethic committee：	No.374 Dianmian Road Kunming P.R. China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 871 63402346	伦理委员会联系人邮箱： Contact email of the ethic committee：	155216763@qq.com

研究实施负责（组长）单位：

昆明医科大学第二附属医院

Primary sponsor：

The second Affiliated Hospital of Kunming Medical University

研究实施负责（组长）单位地址：

中国·云南昆明滇缅大道374号

Primary sponsor's address：

No.374 Dianmian Road Kunming P.R. China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	云南	市(区县)：
Country：	China	Province：	Yunnan	City：
单位(医院)：	昆明医科大学第二附属医院	具体地址：	中国·云南昆明滇缅大道374号
Institution hospital：	The second Affiliated Hospital of Kunming Medical University	Address：	No.374 Dianmian Road Kunming P.R. China

经费或物资来源：

2023年院内临床研究项目

Source(s) of funding：

2023 in-hospital clinical research project

研究疾病：

无颅脑损伤足月儿脑含水量

Target disease：

Brain hydration in term infants without head injury

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

研究设计：

横断面

Study design：

Cross-sectional

研究目的：

获得不同胎龄无颅脑损伤足月儿扰动系数的基线值，分析各胎龄组扰动系数的组间差异。探索日龄、性别、体重、头围与扰动系数的关系，建立预测模型。

Objectives of Study：

The baseline values of the perturbation coefficient of full-term infants without craniocerebral injury at different gestational ages were obtained, and the differences of perturbation coefficients between groups in each gestational age group were analyzed. To explore the relationship between age, gender, weight, head circumference and perturbation coefficient, and to establish a prediction model.

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

1.Perinatal medical history: normal parental cognition, no history of intrauterine hypoxia related to fetal hypoxia during pregnancy, history of intrauterine growth retardation, no history of asphyxia from birth to enrollment, history of resuscitation and rescue, history of head trauma, hereditary metabolic diseases, hypoglycemic encephalopathy, bilirubin encephalopathy, congenital malformations of the brain, TORCH infection and history of central nervous system infection. 42 weeks> gestational age>= 37 weeks, 4000g>= birth weight >= 2500g, Apgar score >7 points, umbilical cord arterial blood PH: 7.24~7.27, BE: -5.60~2.70mmol/L, Lac < 6.00.
2.Clinical manifestations and signs: normal response, normal feeding, no irritability, convulsions, convulsions, impaired consciousness, apnea, no special facial features, no abnormalities in neurological examination, normal primitive reflexes, intact skin on both ears without local infection, ulceration, rash, and no impact on electrode adhesion.
3.Cranial ultrasound: At least two cranial ultrasounds were independently completed by different medical staff at different times from birth to enrollment, and no abnormalities were found in cranial structure, echo, and cerebral blood flow monitoring.
4.The 20-item Behavioral Neurological Scoring Method for Neonates: At least two NBNA scores should be completed independently by different medical staff at different times from birth to enrollment, and each NBNA score should be ≥ 35 points.
5.Those who can cooperate with the examiner, obtain the informed consent of the child's guardian before the operation is carried out, and sign the informed consent form.

排除标准：

1.资料不齐全者；
2.双耳上皮肤局部有破溃、皮疹、感染，影响电极片黏贴者；
3.对电极片黏贴过敏者；
4.生后至入组期间任何一次颅脑超声明确提示颅脑结构、回声、脑血流监测任何一项异常者；
5.任何一次NBNA评分＜35分者；无法配合检查者；
6.在操作实施前未获得患儿监护人知情同意或家属签署拒绝行该检查者；

Exclusion criteria：

1. Those who do not have complete information; 2. Those who have local ulcers, rashes, and infections on the skin on both ears, which affect the adhesion of electrodes; 3. Those who are allergic to electrode sticking; 4. Patients with any abnormalities in cranial structure, echo, and cerebral blood flow monitoring during any period from postbirth to enrollment; 5. any time of NBNA score<35 points or cannot cooperate with the examination; 6. Those who refuse to perform the examination without the informed consent of the child's guardian or the signature of the family member before the implementation of the operation;

研究实施时间：

Study execute time：

从 From 2024-01-01 00:00:00至 To 2026-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2024-01-01 00:00:00 至 To 2025-02-28 00:00:00

干预措施：

Interventions：

组别：	37≤胎龄＜38周	样本量：	46
Group：	37<= gestational age< 38 weeks	Sample size：	46
干预措施：	无	干预措施代码：
Intervention：	No	Intervention code：

组别：	38≤胎龄＜39周	样本量：	46
Group：	38<= gestational age< 39 weeks	Sample size：	46
干预措施：	无	干预措施代码：
Intervention：	No	Intervention code：

组别：	39≤胎龄＜40周	样本量：	46
Group：	39<= gestational age< 40 weeks	Sample size：	46
干预措施：	无	干预措施代码：
Intervention：	No	Intervention code：

组别：	40≤胎龄＜41周	样本量：	46
Group：	40<= gestational age< 41 weeks	Sample size：	46
干预措施：	无	干预措施代码：
Intervention：	No	Intervention code：

组别：	41≤胎龄≤42周	样本量：	46
Group：	41<= gestational age<= 42 weeks	Sample size：	46
干预措施：	无	干预措施代码：
Intervention：	No	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	云南	市(区县)：
Country：	China	Province：	Yunnan	City：
单位(医院)：	昆明医科大学第二附属医院	单位级别：	三级甲等
Institution hospital：	The second Affiliated Hospital of Kunming Medical University	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	扰动系数	指标类型：	主要指标
Outcome：	Perturbation coefficient	Type：	Primary indicator
测量时间点：	住院期间	测量方法：	使用无创脑水肿动态监护仪对每位入组患儿进行监测，共进行两次监测（需在同一日龄内、由不同操作者完成），每次监测10分钟，中间间隔12小时，取两次测量值的均值作为该患儿的扰动系数。
Measure time point of outcome：	During hospitalization	Measure method：	Each enrolled child was monitored using a non-invasive cerebral edema dynamic monitor, and a total of two monitoring sessions (to be completed by different operators within the same day of age) for 10 minutes each time, with an interval of 12 hours in between, and the mean of the two measurements was taken as the perturbation coefficient of the child.

指标中文名：	体重	指标类型：	次要指标
Outcome：	weight	Type：	Secondary indicator
测量时间点：	监测扰动系数当日	测量方法：
Measure time point of outcome：	The perturbation coefficient was monitored on the same day	Measure method：

指标中文名：	头围	指标类型：	次要指标
Outcome：	Head circumference	Type：	Secondary indicator
测量时间点：	监测扰动系数当日	测量方法：
Measure time point of outcome：	The perturbation coefficient was monitored on the same day	Measure method：

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：

正在进行

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）：

无

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

No

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	是Yes
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）：	2026年12月31日试验完成后通过临床试验公共管理平台公众可开放查询或向研究者联系索取原始记录的数据和研究计划书，数据共享持续时间为2026年12月31日试验完成后至永久共享。临床试验公共管理平台不提供下载，只能浏览，要下载数据必须与研究者联系，由研究者提供下载数据。
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	After the completion of the trial on December 31, 2026, the public can open the public to inquire or contact the investigator to obtain the original recorded data and research plan through the clinical trial public management platform, and the data sharing period is from December 31, 2026 to permanent sharing after the completion of the trial. The public management platform for clinical trials does not provide download, only browsing, and to download the data, you must contact the investigator, and the investigator will provide the downloaded data.
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：	数据采集和管理规范化的数据采集和管理系统为病例记录表+基于互联网的EDC系统。项目负责人及项目参与者中高级职称人员依据项目实际情况制定数据管理计划并设计病例报告表；项目负责人以该项目的病例报告表为依据，运用Excel软件设计该项目数据库；数据采集者和录入者均接受过标准化、同质化培训，对所有受试者原始数据进行严格保密，所有计量资料均精确到小数点后2位。监察员需监察研究是否严格遵循研究方案执行，确认所有病例报告表填写完整、数据正确、记录及时、字迹清楚，如有错误或遗漏，需及时要求数据采集者改正，错误处用双线划在错误文字上，保留原记录清楚、可辨，并注明修改时间和修改人签名。不得采用刮、粘、涂等方法掩盖或去除原来的字迹。数据管理员应对每一份病例报告表进行审核，并对病例报告表在数据收集者、监察员、数据录入者之间的传送有专门的记录并妥善保管。数据录入采用双人在不同计算机进行分别录入的方式，两个数据库需进行一致性检验，发现错误后核查原始病例报告表并修改，直至两个数据库达成一致为止；数据每周需在不同电脑上进行一次备份。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Data collection and management the standardized data collection and management system is the case record form + Internet-based EDC system. The project leader and the project participants with senior professional titles formulate data management plans and design case report forms according to the actual situation of the project; the project leader uses Excel software to design the project database based on the case report form of the project; the data collectors and entrants have received standardized and homogeneous training, and the original data of all subjects are kept strictly confidential, and all measurement data are accurate to 2 decimal places. The supervisor shall monitor whether the study is carried out in strict accordance with the study protocol, confirm that all case report forms are completed completely, the data are correct, the records are timely, and the handwriting is clear, if there are errors or omissions, the data collector shall be required to correct them in a timely manner, and the errors shall be marked with a double line on the wrong text, and the original record shall be kept clear and legible, and the modification time and signature of the modifier shall be indicated. Do not use scraping, sticking, painting, etc. to cover up or remove the original handwriting. The data manager shall review each case report form and keep a special record of the transmission of the case report form between the data collector, the monitor, and the data entrant. Data entry is done by two people on different computers, the two databases need to be checked for consistency, and the original case report form is checked and modified until the two databases are agreed, and the data needs to be backed up on different computers once a week.
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2025-01-06 15:25:45