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基于家庭参与的早产儿智护训练对改善小早产儿神经系统发育结局的研究
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注册号:

Registration number:

ChiCTR1900028330 

最近更新日期:

Date of Last Refreshed on:

2019-12-19 

注册时间:

Date of Registration:

2019-12-19 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

基于家庭参与的早产儿智护训练对改善小早产儿神经系统发育结局的研究 

Public title:

The Effect of Family Paticipated Preterm Intellectural Training on Improving Neurodevelopment of Small Preterm Infants 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于家庭参与的早产儿智护训练对改善小早产儿神经系统发育结局的研究 

Scientific title:

The Effect of Family Paticipated Preterm Intellectural Training on Improving Neurodevelopment of Small Preterm 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:

范娟 

研究负责人:

范娟 

Applicant:

Fan Juan 

Study leader:

Fan Juan 

申请注册联系人电话:

Applicant telephone:

+86 13594396150 

研究负责人电话:

Study leader's telephone:

+86 13594396150 

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:

fanjuan_1987@126.com 

研究负责人电子邮件:

Study leader's E-mail:

fanjuan_1987@126.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:

中国重庆市渝中区中山二路136号 

研究负责人通讯地址:

中国重庆市渝中区中山二路136号 

Applicant address:

136 Second Zhongshan Road, Yuzhong District, Chongqing, China 

Study leader's address:

136 Second Zhongshan Road, Yuzhong District, Chongqing, China 

申请注册联系人邮政编码:

Applicant postcode:

400014 

研究负责人邮政编码:

Study leader's postcode:

400014 

申请人所在单位:

重庆医科大学附属儿童医院 

Applicant's institution:

Children's Hospital of Chongqing 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:

(2019)年伦审(研)第(261)号 

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:

重庆医科大学附属儿童医院医学研究伦理委员会 

Name of the ethic committee:

Medical Research Ethics Committee of Children's Hospital of Chongqing Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-11-29 

伦理委员会联系人:

张姝 

Contact Name of the ethic committee:

Zhang Shu 

伦理委员会联系地址:

重庆市渝中区中山二路136号 

Contact Address of the ethic committee:

136 Second Zhongshan Road, Yuzhong District, Chongqing, 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:

重庆医科大学附属儿童医院 

Primary sponsor:

Children's Hospital of Chongqing Medical University 

研究实施负责(组长)单位地址:

中国重庆市渝中区中山二路136号 

Primary sponsor's address:

136 Second Zhongshan Road, Yuzhong District, Chongqing, 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):

重庆

市(区县):

Country:

China

Province:

Chongqing

City:

单位(医院):

重庆医科大学附属儿童医院

具体地址:

渝中区中山二路136号

Institution
hospital:

Children's Hospital of Chongqing Medical University

Address:

136 Second Zhongshan Road, Yuzhong District

经费或物资来源:

自筹课题 

Source(s) of funding:

Self -Financial Support 

研究疾病:

早产儿 

Target disease:

preterm infants 

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:

研究目的:

1. 评估早产儿智护训练在小早产儿群体中推广的可行性,建立标准化的临床应用流程; 2. 评估早产儿智护训练实施的有效性,包括对改善小早产儿视听功能及神经行为发育的作用,和对减少父母在护理小早产儿中焦虑程度的作用,为早产儿智护训练的推广提供医学证据。 

Objectives of Study:

1. To assess the feasibility of intellectual training in the small preterm infants, and to establish the standard of procedure. 2. To assess the effectiveness of intellectual training, including the role of improving audio-visual function and neurobehavior development, the role of reducing the anxiety level of parents in care of small preterm infants, to provide the evidence for promotion of the preterm intellectural training. 

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. 早产儿孕周≥28周,<32周; 2. 纠正胎龄≥36周; 3. 早产儿出院时生命体征平稳,无感染征象,无需用氧支持,体重≥2000g且每日体重增加>15g/kg.d; 4. 父母至少一方研究期间能够全职照顾早产儿,且文化程度在高中及以上; 5. 父母书面同意参与此项研究。 

Inclusion criteria

1. Preterm infants with gestational age of >= 28weeks, and < 32weeks; 2. Corrected gestational age >= 36weeks; 3. Preterm infants with stable vitals, no infection signs, no requirement of oxygen, current weight >= 2000 with daily increment > 15g/kg; 4. At least one of the parents could take full-time care of the infant, whose education attainment should not be lower than high school; 5. Written consent should be obtained from the parents. 

排除标准:

1. 早产儿为小于胎龄儿; 2. 有典型脑损伤的表现,如III-IV级脑室内出血(IVH)、任何程度的脑室周围白质软化(PVL)、临床惊厥发作、脑电图背景明显异常等; 3. 早产儿有先天性感官功能障碍,如视觉障碍、听力障碍; 4. 早产儿接受其他神经行为干预训练。  

Exclusion criteria:

1. Preterm is categorized as small for gestational age; 2. Infants with manifestation of brain injury, such as Grade III-IV intraventricular hemorrhage, variable degree of periventricular leukomalacia, clinical seizure episode, abnomal backgroud of electroencephalogram; 3. Infants with congenital sensory loss, such as hearing loss, visual disorder; 4. Infants are receiving other intervention simutaneously. 

研究实施时间:

Study execute time:

From2019-12-01To 2020-11-30 

征募观察对象时间:

Recruiting time:

From2020-01-01To 2020-10-31 

干预措施:

Interventions:

组别:

干预组

样本量:

25

Group:

Intervention group

Sample size:

干预措施:

早产儿智护训练+常规出院后护理+门诊随访

干预措施代码:

Intervention:

Preterm Intellectural Training; Regular Post-discharge Care; Regular Post-discharge Follow-up

Intervention code:

组别:

对照组

样本量:

25

Group:

Control group

Sample size:

干预措施:

常规出院后护理+门诊随访

干预措施代码:

Intervention:

Regular Post-discharge Care; Regular Post-discharge Follow-up

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

重庆市 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

重庆医科大学附属儿童医院 

单位级别:

三级甲等 

Institution
hospital:

Children's Hospital of Chongqing Medical University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

婴儿运动表现测试

指标类型:

主要指标 

Outcome:

Test of Infant Motor Performance (TIMP)

Type:

Primary indicator 

测量时间点:

出院后1-6月每月一次

测量方法:

Measure time point of outcome:

Monthly up to 6 months after discharge

Measure method:

指标中文名:

发育熵评估

指标类型:

次要指标 

Outcome:

Development Quotient (DQ)

Type:

Secondary indicator 

测量时间点:

出院后1-6月每月一次

测量方法:

Measure time point of outcome:

Monthly up to 6 months after discharge

Measure method:

指标中文名:

体格发育

指标类型:

次要指标 

Outcome:

physical development index

Type:

Secondary indicator 

测量时间点:

出院后1-6月每月一次

测量方法:

身高,体重,头尾

Measure time point of outcome:

Monthly up to 6 months after discharge

Measure method:

height, weight, head circumference

指标中文名:

Teller acuity cards评估

指标类型:

次要指标 

Outcome:

Teller acuity cards evaluation

Type:

Secondary indicator 

测量时间点:

出院后1,3,6月

测量方法:

Measure time point of outcome:

The first, third, sixth month after discharge

Measure method:

指标中文名:

脑干听觉诱发电位

指标类型:

次要指标 

Outcome:

Brainstem Auditory Evoked Potentials (BAEP)

Type:

Secondary indicator 

测量时间点:

出院后1,3,6月

测量方法:

Measure time point of outcome:

The first, third, sixth month after discharge

Measure method:

指标中文名:

父母焦虑量表评估

指标类型:

次要指标 

Outcome:

Parenting Stress Index (PSI)

Type:

Secondary indicator 

测量时间点:

出院后6月

测量方法:

Measure time point of outcome:

The sixth month after discharge

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

无标本采集

组织:

Sample Name:

N/A

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

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 years
最大 Max age 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):

本研究采用随机数字表法产生随机数字,由专人负责。根据产生的随机数字,进行简单随机分组,奇数为干预组,偶数为对照组。

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

The random number will be generated using the random number table by a designated personel. If the random number is odd, assign the study population to intervention group; if it is even, then to the control group.

盲法:

在各个随访评估时点,对早产儿的视听功能及神经行为功能进行评估时,可对评估者施行盲法。

Blinding:

At every endpoint of follow-up, the examiner who will exam the infants audio-visual function and evaluate infants' neurobehavior development will be blinded.

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/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):

2020年12月将对数据进行公开,相关研究人员可向作者要求读取原始数据

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

The original data will be disclosed on Dec 2020. Some researcher could apply the authors for reading original 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:

本研究采用Epidata编制数据库,进行数据的采集和保存。

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

In this study, a Epidata database will be generated to collect and store the original data.

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2019-12-19
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