Exposure to Radiofrequency, Preterm Infant
Conditions
Keywords
preterm neonate, radiofrequency exposure, neurophysiological functions
Brief summary
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
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.
Interventions
OTHERParental questionnaire
Parental questionnaire on pregnancy history and environmental exposure
Daily continuous recording of radiofrequency exposure levels (6 weeks) by placing a dosimeter inside the incubator
OTHERFollow-up of daily infants environmental and clinical parameters
Follow-up of daily infants environmental and clinical parameters: morphological characteristics, drugs, ventilatory support, dietary management, clinical outcomes, incubator data (temperatures…)
Nocturnal polysomnography (at 3 and 6 weeks of life, between 8 pm and 8 am) with recording of sleep (electroencephalography, electrooculography),
DIAGNOSTIC_TESTcerebral hemodynamics
cerebral hemodynamics (near infrared spectroscopy)
DIAGNOSTIC_TESTactivity of the autonomic nervous system
activity of the autonomic nervous system (electrocardiography, analysis of heart rate variability)
Sponsors
Centre Hospitalier Universitaire, Amiens
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| total sleep time in hours | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cerebral hemodynamics | from birth to 6 weeks of life | Cerebral hemodynamics will be determined by measuring regional cerebral oxygen saturation |
| Autonomic nervous system activity | from birth to 6 weeks of life | Autonomic nervous system activity will be determined by measuring means of a heart rate variability |
| apnea frequency | from birth to 6 weeks of life | cardiorespiratory parameters (apnea, bradycardia, desaturation) will be determined |
| bradycardia frequency | from birth to 6 weeks of life | cardiorespiratory parameters (apnea, bradycardia, desaturation) will be determined |
| desaturation frequency | from birth to 6 weeks of life | cardiorespiratory parameters (apnea, bradycardia, desaturation) will be determined |
| Evolution of the anthropomorphic characteristics of the subjects | from birth to 6 weeks of life | anthropomorphic characteristics of the subjects are height and weight. Weight and height will be combined to report BMI in kg/m\^2. |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORPierre Tourneux, Pr
CHU Amiens
PRINCIPAL_INVESTIGATORFrançois Moreau, MD
CHU Amiens
PRINCIPAL_INVESTIGATORLucie Aimée Razafimanantsoa, MD
CHU Amiens
Outcome results
None listed