Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in France / NCT06281093
Recruiting Not applicable

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

NCT06281093 · tracked via the Priya Life Science France tracker
Sponsor
Centre Hospitalier Universitaire, Amiens
Phase
Not applicable
Started
2024-02-20
Last updated
2024-03-13

Condition(s) studied

Preterm Newborn

Investigational drug(s) / intervention(s)

questionaryDaily continuous recording of radiofrequency exposure levelsFollow-up of daily infants clinical parametersrecording of cerebral (EEG)autonomic nervous (ECG) activity

questionary: Parental questionnaire on pregnancy history and environmental exposure

Daily continuous recording of radiofrequency exposure levels: Daily continuous recording of radiofrequency exposure levels (1 week) by positioning a dosimeter close to the incubator

Follow-up of daily infants clinical parameters: Follow-up of daily infants clinical parameters

recording of cerebral (EEG): recording of cerebral (EEG)

autonomic nervous (ECG) activity: autonomic nervous (ECG) activity

Study 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

Sex
ALL
Min age
1 Day
Max age
1 Month
Healthy volunteers
No
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

Primary outcome measure(s)

  • Variation of the spectral power in the α band (8-12 Hz) of the EEG — one week
    The spectral power in the α band (8-12 Hz) of the EEG

Trial sites (1)

FacilityCityRegionStatus
Amiens University Hospital Amiens Picardie Recruiting

More Centre Hospitalier Universitaire, Amiens trials in France

Study of the Link Between Structural Alterations in the Hypothalamus and Cardiac Dysautonomia in Drug-resistant Epilepsy Recruiting
MRI-Eye Tracking Pairing, a Tool for Assessing Social Cognition in Children With ASD Recruiting
Is Cap Assisted Endoscopy Useful in Acute Upper Gastrointestinal Bleeding ? Recruiting
Salivary Replication of BK Virus in Post-kidney Transplant Starting soon
Does Urinary TIMP2 and IGFBP7 Can Identify High Risk Patients of Progression From Mild and Moderate to Severe Acute Kidney Injury During Septic Shock? Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06281093 on ClinicalTrials.gov ↗ ← All trials in France