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临床试验/NL-OMON23933
NL-OMON23933尚未招募不适用

Multi-center non-inferiority study of the monitoring performance of the BAMBI BELT; a wireless device measuring neonatal heart rate, ECG and respiration based on diaphragmatic electromyography

Máxima Medical Center (participating center: Amsterdam Medical Center)0 个研究点目标入组 39 人开始时间: 待定最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
39

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

入选标准

  • Admitted to a participating NICU
  • Being routinely monitored using adhesive electrodes for cardiorespiratory monitoring
  • Written parental informed consent
  • Of a post-menstrual age that is not already fully represented in the study (to include a representative sample, inclusion is performed in three cohorts, <28 weeks, between 28-37 weeks, > 37 weeks)

排除标准

  • Chest skin lesions preventing placement of electrode belt, since the intended use of the belt is for intact skin.
  • Congenital anomalies preventing placement of electrode belt
  • (Effects of) surgery preventing or hindering belt placement, such as a laparotomy or stoma

研究者

发起方
Máxima Medical Center (participating center: Amsterdam Medical Center)

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