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Clinical Trial Summary

Previously, the investigators showed that preterm newborns are exposed chronically to very low radiofrequency levels in average while hospitalized in NICUs. Most of the infants were nevertheless frequently exposed to transient values above 1 V/m. The investigators also showed that an increase in RF exposure is likely to alter the activity of some neurophysiological functions and their regulatory systems in preterm newborns. The investigators hypothesize that above results are extremely specific to the location of the previous study and may be different in other NICU environments. This study will aim at quantifying RF levels to which preterm newborns are exposed during their stay in several NICUs spread across the French territory, and assessing its impact on the central and peripheral nervous systems. The first step of this study will be to quantify the precise, continuous and individual levels of daily RF exposure to which each recruited neonate is subjected during his stay in the different NICUs from birth to 1 week postnatal life. Infants' clinical data (medical history, nutrition, morphology...) will also be continually monitored. At 1 week postnatal life, the investigators will investigate cerebral activity (EEG) and autonomic nervous system activity (ECG, heart rate variability). The impact of RF will be evaluated by analyses of the relationship between exposure levels and the various parameters extracted from the neurophysiological investigation phase.


Clinical Trial Description

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Study Design


Related Conditions & MeSH terms


NCT number NCT06281093
Study type Interventional
Source Centre Hospitalier Universitaire, Amiens
Contact Erwan STÉPHAN-BLANCHARD, Dr
Phone 03 22 82 78 65
Email erwan.stephan@u-picardie.fr
Status Recruiting
Phase N/A
Start date February 20, 2024
Completion date October 2026

See also
  Status Clinical Trial Phase
Terminated NCT02885051 - Evaluation of Pain in Preterm Newborn N/A
Recruiting NCT04757012 - Efficacy Study of a Device Allowing Broadcasting Maternal Voice and Heartbeat in Preterm Newborn (CALIPREM) N/A