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临床试验/NCT01865409
NCT01865409Unknown不适用

Does Kangaroo Care Effects on Heart Rate Variability in Neonates

Fatih University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
2
主要终点
HRV-Sympathetic-Short Measurement-LF

研究概览

简要总结

Physiological processes leading to a preterm infant to be able to feed orally has not been fully understood. The investigators hypothesized that maturation of autonomic nervous system may play a major role in this process and kangaroo care may accelerate this maturation. The investigators will use heart rate variability to measure the maturation of autonomic nervous system.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
32 Weeks 至 35 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Premature infants between 32 t0 35 weeks old
  • After 7 days of extra-uterine life

排除标准

  • Sepsis, infection
  • Cardiac disease
  • Intraventricular hemorrhage, patent ductus arteriosus, necrotizing enterocolitis

结局指标

主要结局

HRV-Sympathetic-Short Measurement-LF

时间窗: 5 Minutes

By using Holter monitorization for 24 haur. LF (frequency domain, low frequency measurement): The low-frequency (LF) spectra represents predominantly sympathetic with some parasympathetic influence in the 0.04-to-0.15 Hz range.

次要结局

  • Time Domain Measurements of HRV(5 Minutes)

研究者

发起方
Fatih University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mehmet Kenan Kanburoglu

MD Kanburoglu, neonatologist

Fatih University

研究点 (2)

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