Study on the effect of oral massage combined with invigorating spleen and invigorating qi massage on preterm infants with difficulty in oral feeding

注册号:

Registration number:

ITMCTR2025000207

最近更新日期:

Date of Last Refreshed on:

2025-01-28

注册时间:

Date of Registration:

2025-01-28

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

口腔按摩结合健脾益气推拿法对经口喂养困难早产儿的应用效果研究

Public title:

Study on the effect of oral massage combined with invigorating spleen and invigorating qi massage on preterm infants with difficulty in oral feeding

注册题目简写:

English Acronym:

研究课题的正式科学名称:

口腔按摩结合健脾益气推拿法对经口喂养困难早产儿的应用效果研究

Scientific title:

Study on the effect of oral massage combined with invigorating spleen and invigorating qi massage on preterm infants with difficulty in oral feeding

研究课题的正式科学名称简写:

Scientific title acronym:

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:

陈雪

研究负责人:

陈雪

Applicant:

Chen Xue

Study leader:

Chen Xue

申请注册联系人电话:

Applicant telephone:

15854348839

研究负责人电话:

Study leader's telephone:

15854348839

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:

342007763@qq.com

研究负责人电子邮件:

Study leader's E-mail:

342007763@qq.com

申请单位网址(自愿提供):

Study leader's 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:

山东省滨州市滨城区黄河二路661号

研究负责人通讯地址:

山东省滨州市滨城区黄河二路661号

Applicant address:

No. 661 Huanghe 2nd Road, Bincheng District, Binzhou City, Shandong Province

Study leader's address:

No. 661 Huanghe 2nd Road, Bincheng District, Binzhou City, Shandong 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:

滨州医学院附属医院

Applicant's institution:

Binzhou Medical College Affiliated Hospital

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

KYLL-126

伦理委员会批件附件:

Approved file of Ethical Committee:

View

批准本研究的伦理委员会名称:

滨州医学院附属医院科研伦理委员会

Name of the ethic committee:

Research Ethics Committee of Binzhou Medical College Affiliated Hospital

伦理委员会批准日期:

Date of approved by ethic committee:

2024/4/15 0:00:00

伦理委员会联系人:

刘彬

Contact Name of the ethic committee:

Liu Bin

伦理委员会联系地址:

滨州市滨城区黄河二路661号

Contact Address of the ethic committee:

No. 661 Huanghe 2nd Road, Bincheng District, Binzhou City

伦理委员会联系人电话:

Contact phone of the ethic committee:

18254360008

伦理委员会联系人邮箱:

Contact email of the ethic committee:

757135183@qq.com

研究实施负责(组长)单位:

滨州医学院附属医院

Primary sponsor:

Binzhou Medical College Affiliated Hospital

研究实施负责(组长)单位地址:

山东省滨州市滨城区黄河二路661号

Primary sponsor's address:

No. 661 Huanghe 2nd Road, Bincheng District, Binzhou City, Shandong 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):

山东省

市(区县):

滨州市

Country:

China

Province:

Shandong Province

City:

Binzhou City

单位(医院):

滨州医学院附属医院

具体地址:

滨州市滨城区黄河二路661号

Institution
hospital:

Binzhou Medical College Affiliated Hospital

Address:

No. 661 Huanghe 2nd Road Bincheng District Binzhou City

经费或物资来源:

自筹

Source(s) of funding:

Self-financing

研究疾病:

吸吮无力

研究疾病代码:

Target disease:

Weak suction ability

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段:

Study phase:

探索性研究/预试验

Pilot clinical trial

研究目的:

探讨在早产儿口腔按摩基础上,联合健脾益气推拿法,对早产儿经口喂养的治疗效果。

Objectives of Study:

Exploring the therapeutic effect of combining oral massage for premature infants with spleen strengthening and qi boosting massage therapy for oral feeding 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:

① 胎龄29-35周;②生命体征稳定;③均需鼻饲喂养;④获得患儿家长的同意,并签署知情同意书。

Inclusion criteria

① Gestational age of 29-35 weeks; ② Vital signs are stable; ③ All require nasal feeding; ④ Obtain the consent of the parents of the affected child and sign an informed consent form.

排除标准:

① 生后有窒息、颅内出血、先天畸形、遗传代谢疾病等;②严重感染;③新生儿坏死性小肠结肠炎;④后期随访中断者;⑤放弃治疗者。

Exclusion criteria:

① Postpartum asphyxia, intracranial hemorrhage, congenital malformations, genetic metabolic diseases, etc Serious infection; ③ Neonatal necrotizing enterocolitis; ④ Interrupted follow-up in the later stage; ⑤ Abandon the therapist.

研究实施时间:

Study execute time:

From 2024-04-15

To      2025-04-15

征募观察对象时间:

Recruiting time:

From 2024-04-15

To      2025-04-15

干预措施:

Interventions:

组别:

对照组

样本量:

40

Group:

control group

Sample size:

干预措施:

对照组仅给予口腔按摩法

干预措施代码:

Intervention:

The control group was only given oral massage

Intervention code:

组别:

干预组

样本量:

40

Group:

Intervention group

Sample size:

干预措施:

干预组给予口腔按摩和健脾益气推拿法

干预措施代码:

Intervention:

The intervention group received oral massage and spleen strengthening and qi boosting massage therapy

Intervention code:

样本总量 Total sample size : 80

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

山东省

市(区县):

滨州市

Country:

China

Province:

Shandong Province

City:

Binzhou City

单位(医院):

滨州医学院附属医院

单位级别:

省级三甲医院

Institution/hospital:

Binzhou Medical College Affiliated Hospital

Level of the institution:

Provincial tertiary hospital

测量指标:

Outcomes:

指标中文名:

体重增长

指标类型:

主要指标

Outcome:

weight gain

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

喂养时间

指标类型:

主要指标

Outcome:

Feeding time

Type:

Primary 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:

征募研究对象情况:

正在进行

Recruiting

年龄范围:

最小 0
Min age years
最大 1
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

实施双盲设计,遵循随机化原则,根据 产生的随机分配序列,逐个将印有分配组别的卡片放入按顺序编码,不透光密封的信封,当研究者确定受试者合格后依顺序拆开信封并将受试者分配到相应的组别

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

Implement double-blind design, follow randomization principles, control information leakage, and based on the generated random allocation sequence, place cards with allocation groups printed on them one by one into sequentially encoded, opaque sealed envelopes. When the researcher determines that the subject is qualified, open the envelopes in order and assign the subject to the corresponding group

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):

2025年通过合作和研讨会共享

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

By 2025, through collaboration and seminar sharing

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:

采用SPSS软件进行数据分析,计量资料以均数±标准差( )表示,组间比较采用t检验,计数资料以“率”表示,组间采用X2检验。

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

SPSS software was used for data analysis, with measurement data presented as mean ± standard deviation, inter group comparisons using t-test, count data presented as "rate", and inter group comparisons using X2 test.

数据管理委员会:

Data Managemen Committee:

Yes

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above