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

NCT06281093 | Recruiting

• 1 other identifier: PI2022_843_0089
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Newborn

Keywords

preterm newborn; radiofrequencies; central and peripheral nervous systems

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• variation of the spectral power in the delta (δ, 0.5-4 Hz) of the EEG

  one week

Interventions

questionary OTHER

Parental questionnaire on pregnancy history and environmental exposure

Daily continuous recording of radiofrequency exposure levels OTHER

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

Follow-up of daily infants clinical parameters OTHER

Follow-up of daily infants clinical parameters

recording of cerebral (EEG) OTHER

recording of cerebral (EEG)

autonomic nervous (ECG) activity OTHER

autonomic nervous (ECG) activity

Eligibility Criteria

• Age: 1 Day - 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead
• University Hospital, Brest: collaborator
• Hospices Civils de Lyon: collaborator
• University Hospital, Strasbourg, France: collaborator
• University Hospital, Toulouse: collaborator

Study Sites (1)

Amiens University Hospital

Amiens, Picardie, 80054, France

RECRUITING

MeSH Terms

Interventions

epicatechin gallate; Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Erwan STÉPHAN-BLANCHARD, Dr

CONTACT

03 22 82 78 65; erwan.stephan@u-picardie.fr

Pierre TOURNEUX, Pr

CONTACT

03 22 08 76 04; tourneux.pierre@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: February 28, 2024
• Study Start: February 20, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)