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NCT Number: NCT06281093

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

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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Key information

Conditions

Age range

1 day–1 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amiens University Hospital

Amiens, Picardie, 80054, France

Location status: Recruiting

Location contact

Brahim SELMAOUI, Dr

SUB_INVESTIGATOR

Débora TUKA

SUB_INVESTIGATOR

Erwan STÉPHAN-BLANCHARD, Dr

PRINCIPAL_INVESTIGATOR

Frédéric TELLIEZ, Pr

SUB_INVESTIGATOR

Géraldine GASCOIN, Pr

PRINCIPAL_INVESTIGATOR

Jean-Michel ROUÉ, Pr

PRINCIPAL_INVESTIGATOR

Karen CHARDON, Pr

SUB_INVESTIGATOR

Marine BUTIN, Pr

PRINCIPAL_INVESTIGATOR

Pierre KUHN, Pr

PRINCIPAL_INVESTIGATOR

Pierre Tourneux, MD

CONTACT

[email protected]

+33 3 22 66 82 86

Stéphane DELANAUD, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Variation of the spectral power in the α band (8-12 Hz) of the EEG

    Time frame: one week

    The spectral power in the α band (8-12 Hz) of the EEG

Secondary outcomes

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

    Time frame: one week

Study contacts

Contact information is provided by the study sponsor or research team.

Erwan STÉPHAN-BLANCHARD, Dr

CONTACT

[email protected]

03 22 82 78 65

Pierre TOURNEUX, Pr

CONTACT

[email protected]

03 22 08 76 04

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

  • Hospices Civils de Lyon
  • University Hospital, Brest
  • University Hospital, Strasbourg, France
  • University Hospital, Toulouse

Registry information

Acronym: CHARLINE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 28, 2024
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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