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【ChiCTR1900026017】A randomized controlled trial for investigation of the associations between a music program and neonatal health outcomes

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基本信息

登记号

ChiCTR1900026017

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2019-09-18

临床申请受理号

靶点

适应症

早產兒

试验通俗题目

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

试验专业题目

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

申办单位信息

申请人联系人

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申请人名称

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联系人邮箱

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联系人邮编

联系人通讯地址

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临床试验信息

试验目的

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

试验分类

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试验类型

随机平行对照

试验分期

其它

随机化

Using block randomization stratified according to the infants gestational age.

盲法

Single blind

试验项目经费来源

No funding

试验范围

目标入组人数

实际入组人数

第一例入组时间

2019-10-21

试验终止时间

2020-09-21

是否属于一致性

入选标准

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.；

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.；

研究者信息

研究负责人姓名

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试验机构

香港中文大學威爾士親王醫院

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研究负责人邮箱

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研究负责人邮编

No postcode

联系人通讯地址