Impact of Chronic Exposure to Radiofrequency Electromagnetic Fields on Neurophysiological Development in the Preterm Neonate (NeuroPrem-RF)
Primary Purpose
Preterm Infant, Exposure to Radiofrequency
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Parental questionnaire
Daily continuous recording of radiofrequency exposure levels
Follow-up of daily infants environmental and clinical parameters
Nocturnal polysomnography
cerebral hemodynamics
activity of the autonomic nervous system
Sponsored by
About this trial
This is an interventional screening trial for Preterm Infant focused on measuring preterm neonate, radiofrequency exposure, neurophysiological functions
Eligibility 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
Sites / Locations
- CHU Amiens
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
preterm neonate
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Cerebral hemodynamics
Cerebral hemodynamics will be determined by measuring regional cerebral oxygen saturation
Autonomic nervous system activity
Autonomic nervous system activity will be determined by measuring means of a heart rate variability
apnea frequency
cardiorespiratory parameters (apnea, bradycardia, desaturation) will be determined
bradycardia frequency
cardiorespiratory parameters (apnea, bradycardia, desaturation) will be determined
desaturation frequency
cardiorespiratory parameters (apnea, bradycardia, desaturation) will be determined
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.
Full Information
NCT ID
NCT03928457
First Posted
April 16, 2019
Last Updated
May 9, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT03928457
Brief Title
Impact of Chronic Exposure to Radiofrequency Electromagnetic Fields on Neurophysiological Development in the Preterm Neonate
Acronym
NeuroPrem-RF
Official Title
Impact of Chronic Exposure to Radiofrequency Electromagnetic Fields on Neurophysiological Development in the Preterm Neonate
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
May 1, 2023 (Actual)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infant, Exposure to Radiofrequency
Keywords
preterm neonate, radiofrequency exposure, neurophysiological functions
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
preterm neonate
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Parental questionnaire
Intervention Description
Parental questionnaire on pregnancy history and environmental exposure
Intervention Type
Other
Intervention Name(s)
Daily continuous recording of radiofrequency exposure levels
Intervention Description
Daily continuous recording of radiofrequency exposure levels (6 weeks) by placing a dosimeter inside the incubator
Intervention Type
Other
Intervention Name(s)
Follow-up of daily infants environmental and clinical parameters
Intervention Description
Follow-up of daily infants environmental and clinical parameters: morphological characteristics, drugs, ventilatory support, dietary management, clinical outcomes, incubator data (temperatures…)
Intervention Type
Other
Intervention Name(s)
Nocturnal polysomnography
Intervention Description
Nocturnal polysomnography (at 3 and 6 weeks of life, between 8 pm and 8 am) with recording of sleep (electroencephalography, electrooculography),
Intervention Type
Diagnostic Test
Intervention Name(s)
cerebral hemodynamics
Intervention Description
cerebral hemodynamics (near infrared spectroscopy)
Intervention Type
Diagnostic Test
Intervention Name(s)
activity of the autonomic nervous system
Intervention Description
activity of the autonomic nervous system (electrocardiography, analysis of heart rate variability)
Primary Outcome Measure Information:
Title
total sleep time in hours
Description
Sleep Structure will be determined by measuring total sleep time, absolute and relative durations of sleep states and sleep state change frequency.
Time Frame
from birth to 6 weeks of life
Title
absolute durations of sleep states in hours
Description
Sleep Structure will be determined by measuring total sleep time, absolute and relative durations of sleep states and sleep state change frequency.
Time Frame
from birth to 6 weeks of life
Title
relative durations of sleep states in hours
Description
Sleep Structure will be determined by measuring total sleep time, absolute and relative durations of sleep states and sleep state change frequency.
Time Frame
from birth to 6 weeks of life
Title
sleep state change frequency
Description
Sleep Structure will be determined by measuring total sleep time, absolute and relative durations of sleep states and sleep state change frequency.
Time Frame
from birth to 6 weeks of life
Secondary Outcome Measure Information:
Title
Cerebral hemodynamics
Description
Cerebral hemodynamics will be determined by measuring regional cerebral oxygen saturation
Time Frame
from birth to 6 weeks of life
Title
Autonomic nervous system activity
Description
Autonomic nervous system activity will be determined by measuring means of a heart rate variability
Time Frame
from birth to 6 weeks of life
Title
apnea frequency
Description
cardiorespiratory parameters (apnea, bradycardia, desaturation) will be determined
Time Frame
from birth to 6 weeks of life
Title
bradycardia frequency
Description
cardiorespiratory parameters (apnea, bradycardia, desaturation) will be determined
Time Frame
from birth to 6 weeks of life
Title
desaturation frequency
Description
cardiorespiratory parameters (apnea, bradycardia, desaturation) will be determined
Time Frame
from birth to 6 weeks of life
Title
Evolution of the anthropomorphic characteristics of the subjects
Description
anthropomorphic characteristics of the subjects are height and weight. Weight and height will be combined to report BMI in kg/m^2.
Time Frame
from birth to 6 weeks of life
10. Eligibility
Sex
All
Maximum Age & Unit of Time
1 Day
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Tourneux, Pr
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
François Moreau, MD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lucie Aimée Razafimanantsoa, MD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of Chronic Exposure to Radiofrequency Electromagnetic Fields on Neurophysiological Development in the Preterm Neonate
We'll reach out to this number within 24 hrs