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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-20

Study Completion Date

2026-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Preterm Newborn

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Interventions

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questionary

Parental questionnaire on pregnancy history and environmental exposure

Intervention Type 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

Intervention Type OTHER

Follow-up of daily infants clinical parameters

Intervention Type OTHER

recording of cerebral (EEG)

Intervention Type OTHER

autonomic nervous (ECG) activity

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

1 Day

Maximum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

No