Clinical trial NCT03928457: Impact of Chronic Exposure to Radiofrequency Electromagnetic Fields on Neurophysiological Development in the Preterm Neonate
Official title: Impact of Chronic Exposure to Radiofrequency Electromagnetic Fields on Neurophysiological Development in the Preterm Neonate
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preterm Infant
Exposure to Radiofrequency
Keywords: preterm neonate
radiofrequency exposure
neurophysiological functions
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2019-04-26
Enrollment: 40
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: total sleep time in hours
timeFrame: from birth to 6 weeks of life
measure: absolute durations of sleep states in hours
timeFrame: from birth to 6 weeks of life
measure: relative durations of sleep states in hours
timeFrame: from birth to 6 weeks of life
measure: sleep state change frequency
timeFrame: from birth to 6 weeks of life
Secondary outcomes:
measure: Cerebral hemodynamics
timeFrame: from birth to 6 weeks of life
measure: Autonomic nervous system activity
timeFrame: from birth to 6 weeks of life
measure: apnea frequency
timeFrame: from birth to 6 weeks of life
measure: bradycardia frequency
timeFrame: from birth to 6 weeks of life
measure: desaturation frequency
timeFrame: from birth to 6 weeks of life
measure: Evolution of the anthropomorphic characteristics of the subjects
timeFrame: from birth to 6 weeks of life
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Pierre Tourneux, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: François Moreau, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Lucie Aimée Razafimanantsoa, MD
role: PRINCIPAL_INVESTIGATOR
References: