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

NCT03928457 | Unknown

• 1 other identifier: PI2018_843_0033
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Infant; Exposure to Radiofrequency

Keywords

preterm neonate; radiofrequency exposure; neurophysiological functions

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (6)

• 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

Study Arms (1)

preterm neonate

EXPERIMENTAL

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

Interventions

Parental questionnaire OTHER

Parental questionnaire on pregnancy history and environmental exposure

preterm neonate

Daily continuous recording of radiofrequency exposure levels OTHER

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

preterm neonate

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…)

preterm neonate

Nocturnal polysomnography OTHER

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

preterm neonate

cerebral hemodynamics DIAGNOSTIC_TEST

cerebral hemodynamics (near infrared spectroscopy)

preterm neonate

activity of the autonomic nervous system DIAGNOSTIC_TEST

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

preterm neonate

Eligibility Criteria

• Age: Up to 1 Day
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• preterm neonates born at 26 to 34 weeks of gestational age
• signed written informed consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80054, France

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Pierre Tourneux, Pr

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• François Moreau, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• Lucie Aimée Razafimanantsoa, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: April 26, 2019
• Study Start: April 1, 2019
• Primary Completion: May 1, 2023
• Study Completion: August 1, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)