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

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ClinicalTrials.gov Identifier: NCT03928457
Recruitment Status : Not yet recruiting
First Posted : April 26, 2019
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Brief 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.

Condition or disease Intervention/treatment Phase
Preterm Infant Exposure to Radiofrequency 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 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Impact of Chronic Exposure to Radiofrequency Electromagnetic Fields on Neurophysiological Development in the Preterm Neonate
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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)


Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   up to 1 Day   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928457


Contacts
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Contact: André LEKE, MD (33)322087607 leke.andre@chu-amiens.fr
Contact: Cécile Fontaine, MD (33)322087608 fontaine.cecile@chu-amiens.fr

Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
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Principal Investigator: Pierre Tourneux, Pr CHU Amiens
Principal Investigator: François Moreau, MD CHU Amiens
Principal Investigator: Lucie Aimée Razafimanantsoa, MD CHU Amiens

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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03928457     History of Changes
Other Study ID Numbers: PI2018_843_0033
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire, Amiens:
preterm neonate
radiofrequency exposure
neurophysiological functions

Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications