Preterm InfantNeuroPrem-RFNCT03928457
Impact of Chronic Exposure to Radiofrequency Electromagnetic Fields on Neurophysiological Development in the Preterm Neonate
A study testing Parental questionnaire, Daily continuous recording of radiofrequency exposure levels and Follow-up of daily infants environmental and clinical parameters in people with Preterm Infant and Exposure to Radiofrequency, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 1 day
- Conditions the study is for
- Preterm Infant, Exposure to Radiofrequency
- What is being tested?
- Parental questionnaire, Daily continuous recording of radiofrequency exposure levels and Follow-up of daily infants environmental and clinical parameters
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jan 2019to 17 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 day
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- preterm neonates born at 26 to 34 weeks of gestational age
- signed written informed consent form
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Preterm infants are potentially exposed to chronic, low levels of electromagnetic fields, especially radiofrequencies, while hospitalized in neonatal intensive care units. Moreover, they may be particularly vulnerable due to increased penetration of radiofrequency waves into the brain during a crucial period of neurodevelopment. This study will aim at evaluating the influence of radiofrequency electromagnetic fields exposure on the neurophysiological development in preterm neonates.
The first part of this study will be devoted to the measurement of environmental electromagnetic fields in order to map their distribution in the paediatric department. From birth and during 6 weeks, the investigators will perform, for each child, a continuous measurement of radiofrequencies at the incubator level. Infants' clinical data (medical history, nutrition, morphology...) and the evolution of the thermal environment in incubators (air and body temperatures) will also be continually monitored. At 3 and 6 weeks of life, the investigators will investigate sleep (EEG, EOG), cerebral hemodynamics (near-infrared spectroscopy), autonomic nervous system activity (ECG, heart rate variability) and various cardiorespiratory parameters (SpO2, apnoea, bradycardia) thanks to a night-time polysomnography.
The impact of radiofrequency electromagnetic fields will be evaluated by analyses of the relationship between exposure levels and the various parameters extracted from the neurophysiological investigation phase.
- Conditions
- Preterm Infant, Exposure to Radiofrequency
- Being tested
- Parental questionnaire, Daily continuous recording of radiofrequency exposure levels, Follow-up of daily infants environmental and clinical parameters, Nocturnal polysomnography, cerebral hemodynamics
- Keywords
- preterm neonate, radiofrequency exposure, neurophysiological functions
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parental questionnaireOther
Parental questionnaire on pregnancy history and environmental exposure
Daily continuous recording of radiofrequency exposure levelsOther
Daily continuous recording of radiofrequency exposure levels (6 weeks) by placing a dosimeter inside the incubator
Follow-up of daily infants environmental and clinical parametersOther
Follow-up of daily infants environmental and clinical parameters: morphological characteristics, drugs, ventilatory support, dietary management, clinical outcomes, incubator data (temperatures…)
Nocturnal polysomnographyOther
Nocturnal polysomnography (at 3 and 6 weeks of life, between 8 pm and 8 am) with recording of sleep (electroencephalography, electrooculography),
cerebral hemodynamicsDiagnostic test
cerebral hemodynamics (near infrared spectroscopy)
activity of the autonomic nervous systemDiagnostic test
activity of the autonomic nervous system (electrocardiography, analysis of heart rate variability)
| Study group | Role | What they receive |
|---|---|---|
| preterm neonate | Experimental | Not described Receives: Other: Parental questionnaire; Other: Daily continuous recording of radiofrequency exposure levels; Other: Follow-up of daily infants environmental and clinical parameters; Other: Nocturnal polysomnography; Diagnostic Test: cerebral hemodynamics; Diagnostic Test: activity of the autonomic nervous system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from birth to 6 weeks of life
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.
Measured: from birth to 6 weeks of life
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.
Measured: from birth to 6 weeks of life
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.
Measured: from birth to 6 weeks of life
Secondary outcomes (6)
Cerebral hemodynamics
Cerebral hemodynamics will be determined by measuring regional cerebral oxygen saturation
Measured: from birth to 6 weeks of life
Autonomic nervous system activity
Autonomic nervous system activity will be determined by measuring means of a heart rate variability
Measured: from birth to 6 weeks of life
apnea frequency
cardiorespiratory parameters (apnea, bradycardia, desaturation) will be determined
Measured: from birth to 6 weeks of life
bradycardia frequency
cardiorespiratory parameters (apnea, bradycardia, desaturation) will be determined
Measured: from birth to 6 weeks of life
desaturation frequency
cardiorespiratory parameters (apnea, bradycardia, desaturation) will be determined
Measured: from birth to 6 weeks of life
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.
Measured: from birth to 6 weeks of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2019
- Study start24 Jan 2019
- Primary completion17 Jan 2023
- Study completion17 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Tourneux, Pr, Principal investigator, CHU AmiensFrançois Moreau, MD, Principal investigator, CHU AmiensLucie Aimée Razafimanantsoa, MD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03928457
- Sponsor's protocol ID
- PI2018_843_0033
- Acronym
- NeuroPrem-RF
- Status last verified
- Jun 2026
- First submitted
- 16 Apr 2019
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Chronic Exposure to Radiofrequency Electromagnetic Fields on Neurophysiological Development in the Preterm Neonate
- ClinicalTrials.gov ID
- NCT03928457
- Acronym / sponsor ID
- NeuroPrem-RF / PI2018_843_0033
- Conditions
- Preterm Infant, Exposure to Radiofrequency
- Keywords
- preterm neonate, radiofrequency exposure, neurophysiological functions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 24 Jan 2019 (actual)
- Primary completion
- 17 Jan 2023 (actual)
- Study completion
- 17 Jan 2023 (actual)
- First posted
- 26 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Preterm infants are potentially exposed to chronic, low levels of electromagnetic fields, especially radiofrequencies, while hospitalized in neonatal intensive care units. Moreover, they may be particularly vulnerable due to increased penetration of radiofrequency waves into the brain during a crucial period of neurodevelopment. This study will aim at evaluating the influence of radiofrequency electromagnetic fields exposure on the neurophysiological development in preterm neonates.
The first part of this study will be devoted to the measurement of environmental electromagnetic fields in order to map their distribution in the paediatric department. From birth and during 6 weeks, the investigators will perform, for each child, a continuous measurement of radiofrequencies at the incubator level. Infants' clinical data (medical history, nutrition, morphology...) and the evolution of the thermal environment in incubators (air and body temperatures) will also be continually monitored. At 3 and 6 weeks of life, the investigators will investigate sleep (EEG, EOG), cerebral hemodynamics (near-infrared spectroscopy), autonomic nervous system activity (ECG, heart rate variability) and various cardiorespiratory parameters (SpO2, apnoea, bradycardia) thanks to a night-time polysomnography.
The impact of radiofrequency electromagnetic fields will be evaluated by analyses of the relationship between exposure levels and the various parameters extracted from the neurophysiological investigation phase.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| preterm neonate | Experimental | Other: Parental questionnaire, Other: Daily continuous recording of radiofrequency exposure levels, Other: Follow-up of daily infants environmental and clinical parameters, Other: Nocturnal polysomnography, Diagnostic Test: cerebral hemodynamics, Diagnostic Test: activity of the autonomic nervous system |
Who may qualify
- Ages
- Up to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- preterm neonates born at 26 to 34 weeks of gestational age
- signed written informed consent form
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parental questionnaireParental questionnaire on pregnancy history and environmental exposure | Other | preterm neonate |
| Daily continuous recording of radiofrequency exposure levelsDaily continuous recording of radiofrequency exposure levels (6 weeks) by placing a dosimeter inside the incubator | Other | preterm neonate |
| Follow-up of daily infants environmental and clinical parametersFollow-up of daily infants environmental and clinical parameters: morphological characteristics, drugs, ventilatory support, dietary management, clinical outcomes, incubator data (temperatures…) | Other | preterm neonate |
| Nocturnal polysomnographyNocturnal polysomnography (at 3 and 6 weeks of life, between 8 pm and 8 am) with recording of sleep (electroencephalography, electrooculography), | Other | preterm neonate |
| cerebral hemodynamicscerebral hemodynamics (near infrared spectroscopy) | Diagnostic test | preterm neonate |
| activity of the autonomic nervous systemactivity of the autonomic nervous system (electrocardiography, analysis of heart rate variability) | Diagnostic test | preterm neonate |
Primary outcome
total sleep time in hours
Time frame: from birth to 6 weeks of life
Sleep Structure will be determined by measuring total sleep time, absolute and relative durations of sleep states and sleep state change frequency.
absolute durations of sleep states in hours
Time frame: from birth to 6 weeks of life
Sleep Structure will be determined by measuring total sleep time, absolute and relative durations of sleep states and sleep state change frequency.
relative durations of sleep states in hours
Time frame: from birth to 6 weeks of life
Sleep Structure will be determined by measuring total sleep time, absolute and relative durations of sleep states and sleep state change frequency.
sleep state change frequency
Time frame: from birth to 6 weeks of life
Sleep Structure will be determined by measuring total sleep time, absolute and relative durations of sleep states and sleep state change frequency.
6 secondary outcomes
Cerebral hemodynamics
Time frame: from birth to 6 weeks of life
Autonomic nervous system activity
Time frame: from birth to 6 weeks of life
apnea frequency
Time frame: from birth to 6 weeks of life
bradycardia frequency
Time frame: from birth to 6 weeks of life
desaturation frequency
Time frame: from birth to 6 weeks of life
Evolution of the anthropomorphic characteristics of the subjects
Time frame: from birth to 6 weeks of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Tourneux, Pr principal investigator
CHU Amiens
François Moreau, MD principal investigator
CHU Amiens
Lucie Aimée Razafimanantsoa, MD principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parental questionnaire, Daily continuous recording of radiofrequency exposure levels and Follow-up of daily infants environmental and clinical parameters in people with Preterm Infant and Exposure to Radiofrequency, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total sleep time in hours (time frame: from birth to 6 weeks of life). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.