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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03928457 on ClinicalTrials.gov