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How Massage and Movement Therapy Help Preterm Infants Gain Weight and Leave the Hospital Sooner in Sabah

注册号：

Registration number：

ITMCTR2024000720

最近更新日期：

Date of Last Refreshed on：

2024-11-22

注册时间：

Date of Registration：

2024-11-22

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

Public title：

How Massage and Movement Therapy Help Preterm Infants Gain Weight and Leave the Hospital Sooner in Sabah

注册题目简写：

English Acronym：

MTKS-PremiS

研究课题的正式科学名称：

Scientific title：

Effects of Massage Therapy and Kinesthetic Stimulation on weight gain and length of stay among preterm infants in Sabah

研究课题的正式科学名称简写：

Scientific title acronym：

MTKS-PremiS

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：

研究负责人：

Applicant：

LILY KONG

Study leader：

LILY KONG

申请注册联系人电话：

Applicant telephone：

+60195860418

研究负责人电话：

Study leader's telephone：

+60195860418

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：

lilyphysio@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

lilyphysio@gmail.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：

研究负责人通讯地址：

Applicant address：

Physiotherapy Unit Queen Elizabeth Hospital Kota Kinabalu Sabah

Study leader's address：

Physiotherapy Unit Queen Elizabeth Hospital Kota Kinabalu Sabah

申请注册联系人邮政编码：

Applicant postcode：

88586

研究负责人邮政编码：

Study leader's postcode：

88586

申请人所在单位：

Applicant's institution：

Queen Elizabeth 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：

NMRR ID 23-00720-4EC (IIR)

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：

Name of the ethic committee：

National Medical Research Register

伦理委员会批准日期：

Date of approved by ethic committee：

2023/10/9 0:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

DR NURAIN BINTI MOHD NOOR

伦理委员会联系地址：

Contact Address of the ethic committee：

Kompleks Institut Kesihatan Negara (NIH) No.1 Jalan Setia Murni U13/52 Seksyen U13 Bandar Setia Alam 40170 Shah Alam Selangor

伦理委员会联系人电话：

Contact phone of the ethic committee：

+603-3362 8398

伦理委员会联系人邮箱：

Contact email of the ethic committee：

mrecsec@moh.gov.my

研究实施负责（组长）单位：

Primary sponsor：

LILY KONG

研究实施负责（组长）单位地址：

Primary sponsor's address：

Physiotherapy Unit Queen Elizabeth Hospital Kota Kinabalu Sabah

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

Source(s) of funding：

NO SOURCE OF FUNDING

研究疾病：

研究疾病代码：

Target disease：

PRETERM INFANTS

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：

其它

Others

研究目的：

Objectives of Study：

i. To determine weight gain among preterm infant who had combination of massage therapy and kinesthetic stimulation and among preterm infant who had kinesthetic stimulation only. ii. To determine length of stay among preterm infant who had combination of massage therapy and kinesthetic stimulation and among preterm infant who had kinesthetic stimulation only. iii. To evaluate the difference in the weight gain among preterm infant who had combination of massage therapy and kinesthetic stimulation compared to preterm infant who had kinesthetic stimulation only. iv. To evaluate the difference in the length of stay among preterm infant who had combination of massage therapy and kinesthetic stimulation compared to preterm infant who had kinesthetic stimulation only.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

Preterm infants will be assigned into an intervention and a control group. The intervention group will receive a program consisted of a combination of massage therapy (MT) and kinesthetic therapy (KS) and the control group will receive KS only. Each infant will receive treatment for 15 minutes/session for a total of 3 sessions daily and to be conducted by a physiotherapist or parent or caregiver. Recruitment process of participants will cease once the numbers of sampling has reached n=84. In this study participants in the control group will be given 15 minutes standard care of KS with 3 repetitions of KS for each session for 3 sessions daily The participants in the intervention group will be given 15 minutes of a combination of MT and KS with 3 repetitions for each session for 3 sessions daily.

纳入标准：

Inclusion criteria

(1) Infant of a Malaysian mother. (2) Born at a gestational age (GA) between 30 and 34 weeks with birth weight between 1300g and 1800g. (3) Parent/caregiver who consented for the study protocol and signed the consent form are recruited. (4) Babies who otherwise medically well on room air and awaiting weight gain to achieve 1.8 kg. (5)Infant who has achieved full feeding as per treatment protocol in NICU management;

排除标准：

Exclusion criteria：

(1) Parent/caregiver who is not willing to give their consent. (2) Infant with congenital joint abnormalities example: Bilateral Hip Dysplasia or Congenital Deformed joints (3) Infants who have underlying medical condition that affect normal weight gain such as congenital heart disease chronic lung disease or surgical gut condition. (4) Positive Syphilis or HIV test in infant. (5) Baby who suffered any skin disorder or having open wounds over skin and body. (6) Delivery complications with Shoulder Dystocia. (7) Fracture Clavicle during birth.

研究实施时间：

Study execute time：

从From 2023-01-02

至To      2024-12-31

征募观察对象时间：

Recruiting time：

从From 2023-11-01

至To      2024-09-30

干预措施：

Interventions：

组别：

样本量：

42

Group：

Control

Sample size：

干预措施：

干预措施代码：

CG

Intervention：

Kinesthetic therapy (KS)

Intervention code：

组别：

样本量：

42

Group：

Intervention

Sample size：

干预措施：

干预措施代码：

IG

Intervention：

Massage therapy (MT) and Kinesthetic therapy (KS)

Intervention code：

样本总量 Total sample size ： 84

研究实施地点：

Countries of recruitment
and research settings：

国家：

省(直辖市)：

市(区县)：

Country：

Malaysia

Province：

SABAH

City：

KOTA KINABALU

单位(医院)：

单位级别：

Institution/hospital：

Queen Elizabeth Hospital

Level of the institution：

Tertiary hospital

测量指标：

Outcomes：

指标中文名：

指标类型：

主要指标

Outcome：

Length of stay

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

At discharge

Measure method：

No. of days in hospital immediately after birth

指标中文名：

指标类型：

次要指标

Outcome：

Daily weight gain

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Daily basis

Measure method：

Weighing scale

指标中文名：

指标类型：

主要指标

Outcome：

Cumulated weight gain

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

At discharged

Measure method：

Weighing scale

指标中文名：

指标类型：

主要指标

Outcome：

Birth weight

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

At birth

Measure method：

Weighing scale (info from clinical notes)

指标中文名：

指标类型：

主要指标

Outcome：

Study Entry Weight

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Once recruited

Measure method：

Weighing scale

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

组织：

Sample Name：

No sample to be collected in the study

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：

结束

Completed

年龄范围：

最小 0 岁
Min age years
最大 1 岁
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）：

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

Randomization will be conducted by an independent person off site using a computer-generated randomly ordered list of 84 allocations with a 1:1 allocation ratio.

盲法：

Blinding：

Non-blinded

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）：

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

Through publication of reports

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：

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

Dignity and privacy of the participant will be protected in future research related to the medical condition and investigational process of this study. Participants names will be kept on a password-protected database and will be linked only with a study identification number for this research. The participant number (001002003...) instead of patient identifiers will be used on participant data collection sheet. All data will be entered into a computer that is password protected. On completion of study data in the computer will be copied to USB pendrive and the data in the computer erased. USB pendrive and any hardcopy data will be stored in a locked office of the investigators and maintained for a minimum of three years after the completion of the study. The USB pendrive and data will be destroyed after that period of storage. Participants will not be allowed to view their personal study data. However they can write to the investigator to request access to study findings.

数据管理委员会：

Data Managemen Committee：

有

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):

Not yet published

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