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临床试验/NCT06281093
NCT06281093招募中不适用

Radiofrequency Fields in Neonatology: Exposure and Impact on the Nervous System

Centre Hospitalier Universitaire, Amiens2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年2月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
2
主要终点
Variation of the spectral power in the α band (8-12 Hz) of the EEG

研究概览

简要总结

Previously, the investigators showed that preterm newborns are exposed chronically to very low radiofrequency levels in average while hospitalized in NICUs. Most of the infants were nevertheless frequently exposed to transient values above 1 V/m. The investigators also showed that an increase in RF exposure is likely to alter the activity of some neurophysiological functions and their regulatory systems in preterm newborns. The investigators hypothesize that above results are extremely specific to the location of the previous study and may be different in other NICU environments.

This study will aim at quantifying RF levels to which preterm newborns are exposed during their stay in several NICUs spread across the French territory, and assessing its impact on the central and peripheral nervous systems. The first step of this study will be to quantify the precise, continuous and individual levels of daily RF exposure to which each recruited neonate is subjected during his stay in the different NICUs from birth to 1 week postnatal life. Infants' clinical data (medical history, nutrition, morphology...) will also be continually monitored. At 1 week postnatal life, the investigators will investigate cerebral activity (EEG) and autonomic nervous system activity (ECG, heart rate variability). The impact of RF will be evaluated by analyses of the relationship between exposure levels and the various parameters extracted from the neurophysiological investigation phase.

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
1 Day 至 1 Month(Child)
性别
All
接受健康志愿者

入选标准

  • preterm newborns born between 26-34 weeks of gestational age

排除标准

  • infants infected,
  • suffering from neurological disorders,
  • serious heart, respiratory, digestive or metabolic diseases;
  • infants born from mothers aged less than 18 years old or deprived of their parental rights

结局指标

主要结局

Variation of the spectral power in the α band (8-12 Hz) of the EEG

时间窗: one week

The spectral power in the α band (8-12 Hz) of the EEG

次要结局

  • variation of the spectral power in the delta (δ, 0.5-4 Hz) of the EEG(one week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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