Radiofrequency Fields in Neonatology: Exposure and Impact on the Nervous System
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: questionary, Daily continuous recording of radiofrequency exposure levels, Follow-up of daily infants clinical parameters, recording of cerebral (EEG).
- Who it may be relevant to
- Registry conditions: Preterm Newborn. Basic parameters: 1 Day — 1 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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
Primary outcome measures
- Variation of the spectral power in the α band (8-12 Hz) of the EEG [Time frame: one week]
Secondary outcome measures (1)
- variation of the spectral power in the delta (δ, 0.5-4 Hz) of the EEG [Time frame: one week]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
France · 1 center
- Amiens University Hospital — Amiens
Identifiers
NCT: NCT06281093 · PI2022_843_0089