Impact of Chronic Exposure to Radiofrequency Electromagnetic Fields on Neurophysiological Development in the Preterm Neonate
NCT03928457 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2023-05-10
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.
Conditions
- Preterm Infant
- Exposure to Radiofrequency
Interventions
- OTHER
-
Parental questionnaire
Parental questionnaire on pregnancy history and environmental exposure
- OTHER
-
Daily continuous recording of radiofrequency exposure levels
Daily continuous recording of radiofrequency exposure levels (6 weeks) by placing a dosimeter inside the incubator
- OTHER
-
Follow-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…)
- OTHER
-
Nocturnal polysomnography
Nocturnal polysomnography (at 3 and 6 weeks of life, between 8 pm and 8 am) with recording of sleep (electroencephalography, electrooculography),
- DIAGNOSTIC_TEST
-
cerebral hemodynamics
cerebral hemodynamics (near infrared spectroscopy)
- DIAGNOSTIC_TEST
-
activity of the autonomic nervous system
activity of the autonomic nervous system (electrocardiography, analysis of heart rate variability)
Sponsors & Collaborators
-
Centre Hospitalier Universitaire, Amiens
lead OTHER
Principal Investigators
-
Pierre Tourneux, Pr · CHU Amiens
-
François Moreau, MD · CHU Amiens
-
Lucie Aimée Razafimanantsoa, MD · CHU Amiens
Study Design
- Allocation
- NA
- Purpose
- SCREENING
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Max Age
- 1 Day
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-04-01
- Primary Completion
- 2023-05-01
- Completion
- 2023-08-31
Countries
- France
Study Locations
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