Actively Recruiting

Phase Not Applicable
Age: 1Day - 1Month
All Genders
NCT06281093

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

Led by Centre Hospitalier Universitaire, Amiens · Updated on 2024-03-13

200

Participants Needed

1

Research Sites

136 weeks

Total Duration

On this page

Sponsors

C

Centre Hospitalier Universitaire, Amiens

Lead Sponsor

U

University Hospital, Brest

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 1Day - 1Month
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Preterm newborns born between 26 and 34 weeks of gestational age
Not Eligible

You will not qualify if you...

  • Infants infected
  • Infants with neurological disorders
  • Infants with serious heart, respiratory, digestive, or metabolic diseases
  • Infants born from mothers younger than 18 years old or deprived of parental rights

AI-Screening

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Trial Site Locations

Total: 1 location

1

Amiens University Hospital

Amiens, Picardie, France, 80054

Actively Recruiting

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Research Team

E

Erwan STÉPHAN-BLANCHARD, Dr

CONTACT

P

Pierre TOURNEUX, Pr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

0

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