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临床试验/NCT05146752
NCT05146752已完成不适用

Application of Schumann Resonance on Premature Infant

Chung Shan Medical University1 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2019年6月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
61
试验地点
1
主要终点
Change from Baseline body weight gain at 4 weeks

研究概览

简要总结

Body weight gain is crucial for preterm newborns, especially those with a low birth weight. Owing to their noninvasive, noncontact, and non-pharmaceutical properties, extremely low frequency electromagnetic fields (ELF-EMFs) are a promising medium of alternative and complementary therapy.

详细描述

Sixty-one preterm newborns of 32-35 weeks' gestational age were recruited from the neonatal intensive care unit of the Chung Shan Medical University Hospital and randomly assigned to one of two groups: the experimental group (n = 31) or the control group (n = 30). Both groups received the same medical care, but the experimental group was exposed to ELF-EMFs until discharge.

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
None

入排标准

年龄范围
26 Weeks 至 42 Weeks(Child)
性别
All
接受健康志愿者
是

入选标准

  • •gestational age (GA) between 32 and 35 weeks
  • •Neonatal Therapeutic Intervention Scoring System (NTISS) score <9

排除标准

  • •(1) a diagnosis of congenital anomaly, intrauterine growth retardation, cerebral palsy, or hydrocephalus; (2) an NTISS score>9

研究组 & 干预措施

Extremely low frequency electromagnetic fields

Experimental

After parental permission for participation was obtained, the preterm newborns were enrolled and divided into the experimental group, which received ELF-EMF therapy after a pretest in addition to regular medical care, and the control group, which received regular medical care only, using a random number table.

干预措施: extremely low frequency electromagnetic fields (Device)

control group

Other

routine care

干预措施: routine care (Other)

结局指标

主要结局

Change from Baseline body weight gain at 4 weeks

时间窗: Baseline, week1, week2, week3, week4.

Although the preterm newborns' body weight was recorded daily, the differences in body weight gain between the two groups were compared every week.The body weights of the preterm newborns were recorded using the same weighing scale at the same time every day.

次要结局

  • Change from Baseline sleep quality at 4 weeks(Baseline, week1, week2, week3, week4.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hsiao-Ling Chuang

Assistant Professor

Chung Shan Medical University

研究点 (1)

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