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

Preterm Newborn Clinical Trial

— CHARLINE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06281093
• Other study ID #: PI2022_843_0089
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2024
• Est. completion date: October 2026

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Erwan STÉPHAN-BLANCHARD, Dr
• Phone: 03 22 82 78 65
• Email: erwan.stephan[@]u-picardie.fr
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 1 Month

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Newborn

Intervention

Other:
• questionary
Parental questionnaire on pregnancy history and environmental exposure
• Daily continuous recording of radiofrequency exposure levels
Daily continuous recording of radiofrequency exposure levels (1 week) by positioning a dosimeter close to the incubator
• Follow-up of daily infants clinical parameters
Follow-up of daily infants clinical parameters
• recording of cerebral (EEG)
recording of cerebral (EEG)
• autonomic nervous (ECG) activity
autonomic nervous (ECG) activity

Locations

Country	Name	City	State
France	Amiens University Hospital	Amiens	Picardie

Sponsors (5)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens	CHU LYON, University Hospital, Brest, University Hospital, Strasbourg, France, University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation of the spectral power in the a band (8-12 Hz) of the EEG	The spectral power in the a band (8-12 Hz) of the EEG	one week
Secondary	variation of the spectral power in the delta (d, 0.5-4 Hz) of the EEG		one week