Impact of Chronic Exposure to Radiofrequency Electromagnetic Fields on Neurophysiological Development in the Preterm Neonate

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Impact of Chronic Exposure to Radiofrequency Electromagnetic Fields on Neurophysiological Development in the Preterm Neonate

Conditions
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Preterm Infant, Exposure to Radiofrequency

Intervention / Treatment
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* Other: Parental questionnaire
* Other: Daily continuous recording of radiofrequency exposure levels
* Other: Follow-up of daily infants environmental and clinical parameters
* Other: Nocturnal polysomnography
* Diagnostic Test: cerebral hemodynamics
* Diagnostic Test: activity of the autonomic nervous system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: preterm neonates born at 26 to 34 weeks of gestational age signed written informed consent form Exclusion Criteria: 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

Ages Eligible for Study
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Maximum Age: 1 Day

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: preterm neonate<br> | Other: Parental questionnaire<br>* Parental questionnaire on pregnancy history and environmental exposure<br>Other: Daily continuous recording of radiofrequency exposure levels<br>* Daily continuous recording of radiofrequency exposure levels (6 weeks) by placing a dosimeter inside the incubator<br>Other: Follow-up of daily infants environmental and clinical parameters<br>* Follow-up of daily infants environmental and clinical parameters: morphological characteristics, drugs, ventilatory support, dietary management, clinical outcomes, incubator data (temperatures…)<br>Other: Nocturnal polysomnography<br>* Nocturnal polysomnography (at 3 and 6 weeks of life, between 8 pm and 8 am) with recording of sleep (electroencephalography, electrooculography),<br>Diagnostic Test: cerebral hemodynamics<br>* cerebral hemodynamics (near infrared spectroscopy)<br>Diagnostic Test: activity of the autonomic nervous system<br>* activity of the autonomic nervous system (electrocardiography, analysis of heart rate variability)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total sleep time in hours | Sleep Structure will be determined by measuring total sleep time, absolute and relative durations of sleep states and sleep state change frequency. | from birth to 6 weeks of life | 
| absolute durations of sleep states in hours | Sleep Structure will be determined by measuring total sleep time, absolute and relative durations of sleep states and sleep state change frequency. | from birth to 6 weeks of life | 
| relative durations of sleep states in hours | Sleep Structure will be determined by measuring total sleep time, absolute and relative durations of sleep states and sleep state change frequency. | from birth to 6 weeks of life | 
| sleep state change frequency | Sleep Structure will be determined by measuring total sleep time, absolute and relative durations of sleep states and sleep state change frequency. | from birth to 6 weeks of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral hemodynamics | Cerebral hemodynamics will be determined by measuring regional cerebral oxygen saturation | from birth to 6 weeks of life | 
| Autonomic nervous system activity | Autonomic nervous system activity will be determined by measuring means of a heart rate variability | from birth to 6 weeks of life | 
| apnea frequency | cardiorespiratory parameters (apnea, bradycardia, desaturation) will be determined | from birth to 6 weeks of life | 
| bradycardia frequency | cardiorespiratory parameters (apnea, bradycardia, desaturation) will be determined | from birth to 6 weeks of life | 
| desaturation frequency | cardiorespiratory parameters (apnea, bradycardia, desaturation) will be determined | from birth to 6 weeks of life | 
| Evolution of the anthropomorphic characteristics of the subjects | anthropomorphic characteristics of the subjects are height and weight. Weight and height will be combined to report BMI in kg/m^2. | from birth to 6 weeks of life | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preterm neonate, radiofrequency exposure, neurophysiological functions