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

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.

Study Overview

• Status: Recruiting
• Conditions: Preterm Newborn
• Intervention / Treatment: Other: questionary; Other: Daily continuous recording of radiofrequency exposure levels; Other: Follow-up of daily infants clinical parameters; Other: recording of cerebral (EEG); Other: autonomic nervous (ECG) activity

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pierre TOURNEUX, Pr; Phone Number: 03 22 08 76 04; Email: tourneux.pierre@chu-amiens.fr
• Study Contact Backup: Name: Erwan STÉPHAN-BLANCHARD, Dr; Phone Number: 03 22 82 78 65; Email: erwan.stephan@u-picardie.fr

Study Locations

• France
  • Picardie
    • Amiens, Picardie, France, 80054
      • Recruiting
      • Amiens university hospital
      • Contact: Pierre Tourneux, MD; Phone Number: +33 3 22 66 82 86; Email: tourneux.pierre@chu-amiens.fr
      • Principal Investigator: Marine BUTIN, Pr
      • Principal Investigator: Erwan STÉPHAN-BLANCHARD, Dr
      • Sub-Investigator: Stéphane DELANAUD, PhD
      • Sub-Investigator: Frédéric TELLIEZ, Pr
      • Sub-Investigator: Karen CHARDON, Pr
      • Sub-Investigator: Brahim SELMAOUI, Dr
      • Sub-Investigator: Débora TUKA
      • Principal Investigator: Jean-Michel ROUÉ, Pr
      • Principal Investigator: Pierre KUHN, Pr
      • Principal Investigator: Géraldine GASCOIN, Pr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variation of the spectral power in the α band (8-12 Hz) of the EEG	The spectral power in the α band (8-12 Hz) of the EEG	one week

Secondary Outcome Measures

Outcome Measure	Time Frame
variation of the spectral power in the delta (δ, 0.5-4 Hz) of the EEG	one week

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Collaborators: University Hospital, Strasbourg, France; University Hospital, Brest; University Hospital, Toulouse; CHU LYON

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: February 20, 2024
• First Submitted That Met QC Criteria: February 20, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: preterm newborn; radiofrequencies; central and peripheral nervous systems
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: PI2022_843_0089

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No