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

Обзор

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.

Вмешательства

• Другое questionary
  Parental questionnaire on pregnancy history and environmental exposure
• Другое Daily continuous recording of radiofrequency exposure levels
  Daily continuous recording of radiofrequency exposure levels (1 week) by positioning a dosimeter close to the incubator
• Другое Follow-up of daily infants clinical parameters
  Follow-up of daily infants clinical parameters
• Другое recording of cerebral (EEG)
  recording of cerebral (EEG)
• Другое autonomic nervous (ECG) activity
  autonomic nervous (ECG) activity

Первичные конечные точки

• Variation of the spectral power in the α band (8-12 Hz) of the EEG [Срок оценки: one week]

Вторичные конечные точки (1)

• variation of the spectral power in the delta (δ, 0.5-4 Hz) of the EEG [Срок оценки: one week]

Критерии участия

Критерии включения

• preterm newborns born between 26-34 weeks of gestational age

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Франция · 1 центр

• Amiens University Hospital — Amiens

Идентификаторы

NCT: NCT06281093 · PI2022_843_0089

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗