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

Centre Hospitalier Universitaire, Amiens

Status

Active, not recruiting

Conditions

Exposure to Radiofrequency

Preterm Infant

Treatments

Other: Nocturnal polysomnography

Other: Daily continuous recording of radiofrequency exposure levels

Other: Parental questionnaire

Diagnostic Test: cerebral hemodynamics

Other: Follow-up of daily infants environmental and clinical parameters

Diagnostic Test: activity of the autonomic nervous system

Study type

Interventional

Funder types

Other

Identifiers

NCT03928457

PI2018_843_0033

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

Under 1 day old

Volunteers

No Healthy Volunteers

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