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临床试验/ChiCTR1900026017
ChiCTR1900026017尚未招募Unknown

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

No funding1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2019年10月21日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方
入组人数
132
试验地点
1
主要终点
Body weight gain

研究概览

简要总结

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

研究设计

研究类型
Interventional
主要目的
随机平行对照
盲法
Single

入排标准

性别
All

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.

研究组 & 干预措施

1

normal music

2

Soft music

结局指标

主要结局

Body weight gain

时间窗: Upon discharge

次要结局

  • Heart rate
  • SpO2
  • Respiratory rate
  • Length of stay

研究者

发起方
No funding

研究点 (1)

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