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

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

Sponsors

Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Source 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.

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.

Overall Status Not yet recruiting
Start Date April 2019
Completion Date December 2022
Primary Completion Date October 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
total sleep time in hours from birth to 6 weeks of life
absolute durations of sleep states in hours from birth to 6 weeks of life
relative durations of sleep states in hours from birth to 6 weeks of life
sleep state change frequency from birth to 6 weeks of life
Secondary Outcome
Measure Time Frame
Cerebral hemodynamics from birth to 6 weeks of life
Autonomic nervous system activity from birth to 6 weeks of life
apnea frequency from birth to 6 weeks of life
bradycardia frequency from birth to 6 weeks of life
desaturation frequency from birth to 6 weeks of life
Evolution of the anthropomorphic characteristics of the subjects from birth to 6 weeks of life
Enrollment 50
Condition
Intervention

Intervention Type: Other

Intervention Name: Parental questionnaire

Description: Parental questionnaire on pregnancy history and environmental exposure

Intervention Type: Other

Intervention Name: Daily continuous recording of radiofrequency exposure levels

Description: Daily continuous recording of radiofrequency exposure levels (6 weeks) by placing a dosimeter inside the incubator

Intervention Type: Other

Intervention Name: Follow-up of daily infants environmental and clinical parameters

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: Nocturnal polysomnography

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: cerebral hemodynamics

Description: cerebral hemodynamics (near infrared spectroscopy)

Intervention Type: Diagnostic Test

Intervention Name: activity of the autonomic nervous system

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

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

Gender: All

Minimum Age: N/A

Maximum Age: 1 Day

Healthy Volunteers: No

Overall Official
Overall Contact

Last Name: André LEKE, MD

Phone: (33)322087607

Email: [email protected]

Verification Date

April 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Acronym NeuroPrem-RF
Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Screening

Masking: None (Open Label)

Source: ClinicalTrials.gov