NCT06281093 Radiofrequency Fields in Neonatology: Exposure and Impact on the Nervous System
| NCT ID | NCT06281093 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire, Amiens |
| Condition | Preterm Newborn |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-02-20 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2024-02-20 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06281093 clinical trial?
This trial is open to participants of all sexes, aged 1 Day or older, up to 1 Month, studying Preterm Newborn. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06281093 currently recruiting?
Yes, NCT06281093 is actively recruiting participants. Contact the research team at erwan.stephan@u-picardie.fr for enrollment information.
Where is the NCT06281093 trial being conducted?
This trial is being conducted at Amiens, France.
Who is sponsoring the NCT06281093 clinical trial?
NCT06281093 is sponsored by Centre Hospitalier Universitaire, Amiens. The trial plans to enroll 200 participants.