Impact of Chronic Exposure to Radiofrequency Electromagnetic Fields on Neurophysiological Development in the Preterm Neonate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- total sleep time in hours
研究概览
简要总结
The massive use of highly technological devices in Neonatal Intensive Care Units may expose preterm neonates to electromagnetic fields, especially radiofrequencies, at low doses but continuously and chronically. Strikingly, the effect of long-term exposure to radiofrequencies on the neurophysiological development of preterm neonates has never been studied so far. The only studies on the impact of chronic exposure to radiofrequencies have been conducted in animals or adult humans, whereas preterm infants may be particularly vulnerable due to increased penetration of radiofrequency waves into the brain during a crucial period of neurodevelopment. The present project will aim at 1) quantifying individual levels of chronic exposure (during 6 weeks) to which preterm neonates are subjected during their stay in the Neonatal Intensive Care Unit, 2) following the evolution of the thermal environment and of the clinical parameters of the neonates after birth, 3) identifying potential alterations of neurophysiological activity (sleep, cerebral hemodynamics, autonomic nervous activity) which will be correlated to actual levels of chronic RF-EMF (radiofrequency electromagnetic fields) exposure.
详细描述
Preterm infants are potentially exposed to chronic, low levels of electromagnetic fields, especially radiofrequencies, while hospitalized in neonatal intensive care units. Moreover, they may be particularly vulnerable due to increased penetration of radiofrequency waves into the brain during a crucial period of neurodevelopment. This study will aim at evaluating the influence of radiofrequency electromagnetic fields exposure on the neurophysiological development in preterm neonates.
The first part of this study will be devoted to the measurement of environmental electromagnetic fields in order to map their distribution in the paediatric department. From birth and during 6 weeks, the investigators will perform, for each child, a continuous measurement of radiofrequencies at the incubator level. Infants' clinical data (medical history, nutrition, morphology...) and the evolution of the thermal environment in incubators (air and body temperatures) will also be continually monitored. At 3 and 6 weeks of life, the investigators will investigate sleep (EEG, EOG), cerebral hemodynamics (near-infrared spectroscopy), autonomic nervous system activity (ECG, heart rate variability) and various cardiorespiratory parameters (SpO2, apnoea, bradycardia) thanks to a night-time polysomnography.
The impact of radiofrequency electromagnetic fields 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
- Screening
- 盲法
- None
入排标准
- 年龄范围
- — 至 1 Day（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •preterm neonates born at 26 to 34 weeks of gestational age
- •signed written informed consent form
排除标准
- •infants infected
- •infants 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
- •non covered by national health insurance
研究组 & 干预措施
preterm neonate
干预措施: Parental questionnaire (Other)
preterm neonate
干预措施: Daily continuous recording of radiofrequency exposure levels (Other)
preterm neonate
干预措施: Follow-up of daily infants environmental and clinical parameters (Other)
preterm neonate
干预措施: Nocturnal polysomnography (Other)
preterm neonate
干预措施: cerebral hemodynamics (Diagnostic Test)
preterm neonate
干预措施: activity of the autonomic nervous system (Diagnostic Test)
结局指标
主要结局
total sleep time in hours
时间窗: from birth to 6 weeks of life
Sleep Structure will be determined by measuring total sleep time, absolute and relative durations of sleep states and sleep state change frequency.
relative durations of sleep states in hours
时间窗: from birth to 6 weeks of life
Sleep Structure will be determined by measuring total sleep time, absolute and relative durations of sleep states and sleep state change frequency.
sleep state change frequency
时间窗: from birth to 6 weeks of life
Sleep Structure will be determined by measuring total sleep time, absolute and relative durations of sleep states and sleep state change frequency.
absolute durations of sleep states in hours
时间窗: from birth to 6 weeks of life
Sleep Structure will be determined by measuring total sleep time, absolute and relative durations of sleep states and sleep state change frequency.
次要结局
- Autonomic nervous system activity(from birth to 6 weeks of life)
- apnea frequency(from birth to 6 weeks of life)
- desaturation frequency(from birth to 6 weeks of life)
- Cerebral hemodynamics(from birth to 6 weeks of life)
- bradycardia frequency(from birth to 6 weeks of life)
- Evolution of the anthropomorphic characteristics of the subjects(from birth to 6 weeks of life)