Impact of Chronic Exposure to Radiofrequency Electromagnetic Fields on Neurophysiological Development in the Preterm Neonate (NeuroPrem-RF)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Preterm Infant; Exposure to Radiofrequency
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cécile Fontaine, MD; Phone Number: (33)322087608; Email: fontaine.cecile@chu-amiens.fr

Study Locations

• France
  • Amiens, France, 80054
    • CHU Amiens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 day (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: preterm neonate

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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Investigators: Principal Investigator: Pierre Tourneux, Pr, CHU Amiens; Principal Investigator: François Moreau, MD, CHU Amiens; Principal Investigator: Lucie Aimée Razafimanantsoa, MD, CHU Amiens

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): May 1, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: April 16, 2019
• First Submitted That Met QC Criteria: April 23, 2019
• First Posted (Actual): April 26, 2019

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: preterm neonate; radiofrequency exposure; neurophysiological functions
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: PI2018_843_0033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No