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临床试验/NCT04009655
NCT04009655已完成不适用

The Effects of Music Therapy on Near-infrared Spectroscopy and Electroencephalogram in Premature Infants

Children's Hospital of Fudan University1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2019年8月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
1
主要终点
change of brain oxygen saturation

研究概览

简要总结

Music has been consistently shown magic power in brain plasticity. Several study proved music can influence electronic activity of preterm infants' brain, while none study covered region oxygen metabolic. The investigators aim to discover the effects of music therapy on near-infrared spectroscopy and electroencephalogram in premature infants.

详细描述

Previous studies of music therapy have made some achievements for adult Parkinson's disease, schizophrenia, depression, anxiety, post-traumatic stress and pediatric autism spectrum disorders. For newborns, studies mainly focused on the effects of basic vital signs, feeding and pain score decreasing. So far, no studies evaluating the effect of music therapy on brain oxygen metabolic and electronic activity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
224 Days 至 258 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Postmenstrual age of 32-36+6 weeks.
  • Appropriate weight for gestational age.
  • To have signed an informed consent to participate in the study.
  • Have reached clinical stability.

排除标准

  • Have nervous system diseases or obvious nervous system symptoms.
  • Severe congenital diseases.
  • The maintenance of sedative or analgesic drugs.
  • Support with mechanical ventilation.

结局指标

主要结局

change of brain oxygen saturation

时间窗: from the start of the intervention to the end of the 3rd day

near-infrared spectroscopy to monitor brain oxygen saturation

次要结局

  • change of respiratory rates(from the start of the intervention to the end of the 3rd day)
  • Burdjalov Scores of amplitude integrated electroencephalogram(from the start of the intervention to the end of the 3rd day)
  • change of heart rates(from the start of the intervention to the end of the 3rd day)
  • change of pluse oxygen saturation(from the start of the intervention to the end of the 3rd day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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