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

Preterm Infant Clinical Trial

— NeuroPrem-RF  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03928457
• Other study ID #: PI2018_843_0033
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: August 2023

Study information

• Verified date: May 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: August 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Day

Eligibility

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

Related Conditions & MeSH terms

• Exposure to Radiofrequency
• Premature Birth
• Preterm Infant

Intervention

Other:
• Parental questionnaire
Parental questionnaire on pregnancy history and environmental exposure
• Daily continuous recording of radiofrequency exposure levels
Daily continuous recording of radiofrequency exposure levels (6 weeks) by placing a dosimeter inside the incubator
• 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…)
• 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)
• activity of the autonomic nervous system
activity of the autonomic nervous system (electrocardiography, analysis of heart rate variability)

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Cerebral hemodynamics	Cerebral hemodynamics will be determined by measuring regional cerebral oxygen saturation	from birth to 6 weeks of life
Secondary	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
Secondary	apnea frequency	cardiorespiratory parameters (apnea, bradycardia, desaturation) will be determined	from birth to 6 weeks of life
Secondary	bradycardia frequency	cardiorespiratory parameters (apnea, bradycardia, desaturation) will be determined	from birth to 6 weeks of life
Secondary	desaturation frequency	cardiorespiratory parameters (apnea, bradycardia, desaturation) will be determined	from birth to 6 weeks of life
Secondary	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