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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06281093
Acronym
CHARLINE
Enrollment
200
Registered
2024-02-28
Start date
2024-02-20
Completion date
2026-10-31
Last updated
2024-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Newborn

Keywords

preterm newborn, radiofrequencies, central and peripheral nervous systems

Brief 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.

Interventions

OTHERquestionary

Parental questionnaire on pregnancy history and environmental exposure

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

OTHERFollow-up of daily infants clinical parameters

Follow-up of daily infants clinical parameters

OTHERrecording of cerebral (EEG)

recording of cerebral (EEG)

OTHERautonomic nervous (ECG) activity

autonomic nervous (ECG) activity

Sponsors

University Hospital, Brest
CollaboratorOTHER
Hospices Civils de Lyon
CollaboratorOTHER
University Hospital, Strasbourg, France
CollaboratorOTHER
University Hospital, Toulouse
CollaboratorOTHER
Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Days to 1 Months
Healthy volunteers
No

Inclusion criteria

* preterm newborns born between 26-34 weeks of gestational age

Exclusion criteria

* infants infected, * 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

Design outcomes

Primary

MeasureTime frameDescription
Variation of the spectral power in the α band (8-12 Hz) of the EEGone weekThe spectral power in the α band (8-12 Hz) of the EEG

Secondary

MeasureTime frame
variation of the spectral power in the delta (δ, 0.5-4 Hz) of the EEGone week

Countries

France

Contacts

Primary ContactErwan STÉPHAN-BLANCHARD, Dr
erwan.stephan@u-picardie.fr03 22 82 78 65
Backup ContactPierre TOURNEUX, Pr
tourneux.pierre@chu-amiens.fr03 22 08 76 04

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026