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Completed

NCT Number: NCT03928457

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

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.

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Key information

Conditions

Preterm Infant Exposure to Radiofrequency Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 1 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens

Amiens, 80054, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Parental questionnaire

Other

Parental questionnaire on pregnancy history and environmental exposure

Daily continuous recording of radiofrequency exposure levels

Other

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

Other

Follow-up of daily infants environmental and clinical parameters: morphological characteristics, drugs, ventilatory support, dietary management, clinical outcomes, incubator data (temperatures…)

Nocturnal polysomnography

Other

Nocturnal polysomnography (at 3 and 6 weeks of life, between 8 pm and 8 am) with recording of sleep (electroencephalography, electrooculography),

cerebral hemodynamics

Diagnostic Test

cerebral hemodynamics (near infrared spectroscopy)

activity of the autonomic nervous system

Diagnostic Test

activity of the autonomic nervous system (electrocardiography, analysis of heart rate variability)

Primary outcomes

  1. total sleep time in hours

    Time frame: 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.

  2. absolute durations of sleep states in hours

    Time frame: 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.

  3. relative durations of sleep states in hours

    Time frame: 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.

  4. sleep state change frequency

    Time frame: 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 outcomes

  1. Cerebral hemodynamics

    Time frame: from birth to 6 weeks of life

    Cerebral hemodynamics will be determined by measuring regional cerebral oxygen saturation

  2. Autonomic nervous system activity

    Time frame: from birth to 6 weeks of life

    Autonomic nervous system activity will be determined by measuring means of a heart rate variability

  3. apnea frequency

    Time frame: from birth to 6 weeks of life

    cardiorespiratory parameters (apnea, bradycardia, desaturation) will be determined

  4. bradycardia frequency

    Time frame: from birth to 6 weeks of life

    cardiorespiratory parameters (apnea, bradycardia, desaturation) will be determined

  5. desaturation frequency

    Time frame: from birth to 6 weeks of life

    cardiorespiratory parameters (apnea, bradycardia, desaturation) will be determined

  6. Evolution of the anthropomorphic characteristics of the subjects

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: NeuroPrem-RF

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Apr 26, 2019
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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