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RECRUITING
NCT06281093
NA

Radiofrequency Fields in Neonatology: Exposure and Impact on the Nervous System

Sponsor: Centre Hospitalier Universitaire, Amiens

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

1 Day - 1 Month

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2024-02-20

Completion Date

2026-10

Last Updated

2024-03-13

Healthy Volunteers

No

Conditions

Interventions

OTHER

questionary

Parental questionnaire on pregnancy history and environmental exposure

OTHER

Daily continuous recording of radiofrequency exposure levels

Daily continuous recording of radiofrequency exposure levels (1 week) by positioning a dosimeter close to the incubator

OTHER

Follow-up of daily infants clinical parameters

Follow-up of daily infants clinical parameters

OTHER

recording of cerebral (EEG)

recording of cerebral (EEG)

OTHER

autonomic nervous (ECG) activity

autonomic nervous (ECG) activity

Locations (1)

Amiens University Hospital

Amiens, Picardie, France