ChiCTR1900026017 版本V1.0 版本创建时间2019/09/18 08:40:03 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR1900026017 

最近更新日期：

Date of Last Refreshed on：

 2019-09-18 08:35:33 

注册时间：

Date of Registration：

 2019-09-18 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

A randomized controlled trial for investigation of the associations between a music program and neonatal health outcomes

Public title：

A randomized controlled trial for investigation of the associations between a music program and neonatal health outcomes

注册题目简写：

English Acronym：

研究课题的正式科学名称：

A randomized controlled trial for investigation of the associations between a music program and neonatal health outcomes

Scientific title：

A randomized controlled trial for investigation of the associations between a music program and neonatal health outcomes

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：

Cheng Shuk Man 

研究负责人：

Cheng Shuk Man 

Applicant：

Cheng Shuk Man 

Study leader：

Cheng Shuk Man 

申请注册联系人电话：

Applicant telephone：

 +852 35056578

研究负责人电话：

Study leader's
telephone：

+852 35056578

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：

 csm576@ha.org.hk

研究负责人电子邮件：

Study leader's E-mail：

 csm576@ha.org.hk

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：

中國香港特別行政區新界牛池灣豐盛街63號風景區2座32/F

研究负责人通讯地址：

中國香港特別行政區新界牛池灣豐盛街63號風景區2座32/F

Applicant address：

Flat F, 32/F, Block 2, Scenic View, 63 Fung Shing Street, Ngau Chi Wan, Hong Kong SAR, China

Study leader's address：

Flat F, 32/F, Block 2, Scenic View, 63 Fung Shing Street, Ngau Chi Wan, Hong Kong SAR, 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：

 No postcode

申请人所在单位：

香港中文大學威爾士親王醫院

Applicant's institution：

Prince of Wales Hospital, Chinese University of Hong Kong

研究负责人所在单位：

香港中文大學威爾士親王醫院

Affiliation of the Leader：

Prince of Wales Hospital, Chinese University of Hong Kong

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：

 1

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：

香港中文大學-新界東醫院聯網臨床研究倫理聯席委員會

Name of the ethic committee：

Joint the Chinese University of Hong Kong New Territories East Cluster Clinical Research Ethics Committee (CREC)

伦理委员会批准日期：

Date of approved by ethic committee：

 2019-07-09 00:00:00

伦理委员会联系人：

Envy Lee

Contact Name of the ethic committee：

Envy Lee

伦理委员会联系地址：

中國香港特別行政區新界沙田威爾士親王醫院呂志和臨床科學大樓8/F

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong SAR, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 3505 3935

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：

香港中文大學威爾士親王醫院

Primary sponsor：

Prince of Wales Hospital, Chinese University of Hong Kong

研究实施负责（组长）单位地址：

中國香港特別行政區新界牛池灣豐盛街63號風景區2座32/F

Primary sponsor's address：

Flat F, 32/F, Block 2, Scenic View, 63 Fung Shing Street, Ngau Chi Wan, Hong Kong SAR, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

No funding

Source(s) of funding：

No funding

研究疾病：

早產兒  

Target disease：

Premature baby

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：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

To investigate the impact of a music program on the physiological response, weight gain and length of stay of preterm infants.  

Objectives of Study：

To investigate the impact of a music program on the physiological response, weight gain and length of stay of preterm infants.

药物成份或治疗方案详述：

The music chosen are lullabies with preset volume at 60 dB for the normal music group and preset volume at 30 dB for the soft music group. Music will be provided 2 times/day each for 30 minutes. Twinkle Twinkle Little Star and Brahms’ Lullaby will be played for the am and pm sessions respectively until the infant participant is transferred out of the incubator or discharged from hospital. Each infant participant will have their own music player which will be placed at the head end of the infant incubator or Giraffe. Distance of the players to the babies’ ears will be around 20-30cm. All music players will be preset to auto sleep mode after each 30-minute music session. The music choice, duration, sound level, frequency and distance between music player and infants’ ears are decided according to literature review and suggestion from a music therapist. During music time, nurses will be advised to minimize or avoid routine nursing care if possible and provide quiet time by lowering the conversation volume. “Music in progress” signage will be placed on the incubator/Giraffe as a reminder that music intervention is in progress. Nurses will record down the starting time in the data sheet.  

Description for medicine or protocol of treatment in detail：

The music chosen are lullabies with preset volume at 60 dB for the normal music group and preset volume at 30 dB for the soft music group. Music will be provided 2 times/day each for 30 minutes. Twinkle Twinkle Little Star and Brahms Lullaby will be played for the am and pm sessions respectively until the infant participant is transferred out of the incubator or discharged from hospital. Each infant participant will have their own music player which will be placed at the head end of the infant incubator or Giraffe. Distance of the players to the babies ears will be around 20-30cm. All music players will be preset to auto sleep mode after each 30-minute music session. The music choice, duration, sound level, frequency and distance between music player and infants’ ears are decided according to literature review and suggestion from a music therapist. During music time, nurses will be advised to minimize or avoid routine nursing care if possible and provide quiet time by lowering the conversation volume. “Music in progress” signage will be placed on the incubator/Giraffe as a reminder that music intervention is in progress. Nurses will record down the starting time in the data sheet.  

纳入标准：

Infants in the Neonatal Unit with:
(1) PCA 28 – 37 weeks;
(2) >=48 hours old, and
(3) hemodynamically stable (i.e., not requiring any inotropic support). For those infants who fulfill the inclusion criteria, but are nursed in extra-humid environment, they will be recruited after completion of extra-humid care to prevent damage to the music player.

Inclusion criteria

Infants in the Neonatal Unit with:
(1) PCA 28 – 37 weeks;
(2) >=48 hours old, and
(3) hemodynamically stable (i.e., not requiring any inotropic support). For those infants who fulfill the inclusion criteria, but are nursed in extra-humid environment, they will be recruited after completion of extra-humid care to prevent damage to the music player.

排除标准：

(1) known hearing impairment or deafness;
(2) any acute neurological conditions (e.g. HIE, seizure);
(3) ongoing hypothermic therapy;
(4) on high frequency oscillatory ventilation, and
(5) in cot care.
Since hearing tests will not be done during NICU hospitalization, all recruited infants hearing test results will be retrospectively reviewed after transferal to special care baby unit (SCBU). Those infants who fail their hearing tests will be excluded from data analysis.

Exclusion criteria：

(1) known hearing impairment or deafness;
(2) any acute neurological conditions (e.g. HIE, seizure);
(3) ongoing hypothermic therapy;
(4) on high frequency oscillatory ventilation, and
(5) in cot care.
Since hearing tests will not be done during NICU hospitalization, all recruited infants hearing test results will be retrospectively reviewed after transferal to special care baby unit (SCBU). Those infants who fail their hearing tests will be excluded from data analysis.

研究实施时间：

Study execute time：

从 From 2019-10-21 00:00:00至 To 2020-09-21 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2019-10-21 00:00:00 至 To 2020-09-21 00:00:00

干预措施：

Interventions：

组别：

1

样本量：

 66

Group：

1

Sample size：

干预措施：

normal music

干预措施代码：

Intervention：

normal music

Intervention code：

组别：

2

样本量：

 66

Group：

2

Sample size：

干预措施：

Soft music

干预措施代码：

Intervention：

Soft music

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 威爾士親王醫院 

单位级别：

 三甲医院 

Institution
hospital：

Prince of Wales Hospital

Level of the institution：

Tertiary A Hospital

测量指标：

Outcomes：

指标中文名：

Body weight gain

指标类型：

主要指标

Outcome：

Body weight gain

Type：

Primary indicator

测量时间点：

Upon discharge

测量方法：

weight

Measure time point of outcome：

Upon discharge

Measure method：

weight

指标中文名：

Heart rate

指标类型：

次要指标

Outcome：

Heart rate

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

SpO2

指标类型：

次要指标

Outcome：

SpO2

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Respiratory rate

指标类型：

次要指标

Outcome：

Respiratory rate

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Length of stay

指标类型：

次要指标

Outcome：

Length of stay

Type：

Secondary 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：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 岁 years
最大 Max age 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）：

Using block randomization stratified according to the infants gestational age.

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

Using block randomization stratified according to the infants gestational age.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Single blind

Blinding：

Single blind

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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）：

The results of this study will be disseminated through presentations in professional conferences and submission to academic journals.

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

The results of this study will be disseminated through presentations in professional conferences and submission to academic journals.

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：

The “Music program for preterm infants in NICU” will be conducted in the PWH NICU. Staff briefing will be delivered to the NICU nurses before start of the program. Case nurses will be responsible to turn on the music players, choose the appropriate music for the music session, turn off the players after the 30-minutes music session, and place the players back into the bedside trolley to prevent prolonged music exposure if there are technical issues and the music player fails to switch off. The characteristics of the infant participants including gender, sex, gestational age at birth, PCA at the time of recruitment and birth weight will be collected.

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

The “Music program for preterm infants in NICU” will be conducted in the PWH NICU. Staff briefing will be delivered to the NICU nurses before start of the program. Case nurses will be responsible to turn on the music players, choose the appropriate music for the music session, turn off the players after the 30-minutes music session, and place the players back into the bedside trolley to prevent prolonged music exposure if there are technical issues and the music player fails to switch off. The characteristics of the infant participants including gender, sex, gestational age at birth, PCA at the time of recruitment and birth weight will be collected.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2019-09-18 08:35:33