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

NCT06281093 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-03-13

No results posted yet for this study

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

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

Sponsors & Collaborators

  • University Hospital, Brest

    collaborator OTHER
  • Hospices Civils de Lyon

    collaborator OTHER
  • University Hospital, Strasbourg, France

    collaborator OTHER
  • University Hospital, Toulouse

    collaborator OTHER
  • Centre Hospitalier Universitaire, Amiens

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Day
Max Age
1 Month
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-20
Primary Completion
2026-09-30
Completion
2026-10-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06281093 on ClinicalTrials.gov