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Completed
NCT03928457
Impact of Chronic Exposure to Radiofrequency Electromagnetic Fields on Neurophysiological Development in the Preterm Neonate
Conditions: Preterm Infant, Exposure to Radiofrequency
Sex: All
Ages: N/A – 1 Day
Healthy volunteers: No
Phase: NA
Enrollment: 40
Sponsor: Centre Hospitalier Universitaire, Amiens
Location: CHU Amiens Amiens
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.
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
Source: ClinicalTrials.gov (NCT03928457). StuddyBuddy aggregates publicly available trial information.