Preterm Infant Clinical Trial
— NeuroPrem-RFOfficial title:
Impact of Chronic Exposure to Radiofrequency Electromagnetic Fields on Neurophysiological Development in the Preterm Neonate
Verified date | May 2023 |
Source | Centre Hospitalier Universitaire, Amiens |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The massive use of highly technological devices in Neonatal Intensive Care Units may expose preterm neonates to electromagnetic fields, especially radiofrequencies, at low doses but continuously and chronically. Strikingly, the effect of long-term exposure to radiofrequencies on the neurophysiological development of preterm neonates has never been studied so far. The only studies on the impact of chronic exposure to radiofrequencies have been conducted in animals or adult humans, whereas preterm infants may be particularly vulnerable due to increased penetration of radiofrequency waves into the brain during a crucial period of neurodevelopment. The present project will aim at 1) quantifying individual levels of chronic exposure (during 6 weeks) to which preterm neonates are subjected during their stay in the Neonatal Intensive Care Unit, 2) following the evolution of the thermal environment and of the clinical parameters of the neonates after birth, 3) identifying potential alterations of neurophysiological activity (sleep, cerebral hemodynamics, autonomic nervous activity) which will be correlated to actual levels of chronic RF-EMF (radiofrequency electromagnetic fields) exposure.
Status | Active, not recruiting |
Enrollment | 40 |
Est. completion date | August 2023 |
Est. primary completion date | May 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 1 Day |
Eligibility | Inclusion Criteria: - preterm neonates born at 26 to 34 weeks of gestational age - signed written informed consent form Exclusion Criteria: - infants infected - infants 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 - non covered by national health insurance |
Country | Name | City | State |
---|---|---|---|
France | CHU Amiens | Amiens |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire, Amiens |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | total sleep time in hours | Sleep Structure will be determined by measuring total sleep time, absolute and relative durations of sleep states and sleep state change frequency. | from birth to 6 weeks of life | |
Primary | absolute durations of sleep states in hours | Sleep Structure will be determined by measuring total sleep time, absolute and relative durations of sleep states and sleep state change frequency. | from birth to 6 weeks of life | |
Primary | relative durations of sleep states in hours | Sleep Structure will be determined by measuring total sleep time, absolute and relative durations of sleep states and sleep state change frequency. | from birth to 6 weeks of life | |
Primary | sleep state change frequency | Sleep Structure will be determined by measuring total sleep time, absolute and relative durations of sleep states and sleep state change frequency. | from birth to 6 weeks of life | |
Secondary | Cerebral hemodynamics | Cerebral hemodynamics will be determined by measuring regional cerebral oxygen saturation | from birth to 6 weeks of life | |
Secondary | Autonomic nervous system activity | Autonomic nervous system activity will be determined by measuring means of a heart rate variability | from birth to 6 weeks of life | |
Secondary | apnea frequency | cardiorespiratory parameters (apnea, bradycardia, desaturation) will be determined | from birth to 6 weeks of life | |
Secondary | bradycardia frequency | cardiorespiratory parameters (apnea, bradycardia, desaturation) will be determined | from birth to 6 weeks of life | |
Secondary | desaturation frequency | cardiorespiratory parameters (apnea, bradycardia, desaturation) will be determined | from birth to 6 weeks of life | |
Secondary | Evolution of the anthropomorphic characteristics of the subjects | anthropomorphic characteristics of the subjects are height and weight. Weight and height will be combined to report BMI in kg/m^2. | from birth to 6 weeks of life |
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