Preterm NewbornCHARLINENCT06281093
Radiofrequency Fields in Neonatology: Exposure and Impact on the Nervous System
A study testing questionary, Daily continuous recording of radiofrequency exposure levels and Follow-up of daily infants clinical parameters in people with Preterm Newborn, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 1 month
- Conditions the study is for
- Preterm Newborn
- What is being tested?
- questionary, Daily continuous recording of radiofrequency exposure levels and Follow-up of daily infants clinical parameters
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 20 Feb 2024to Oct 2026
- 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 1 day to 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- preterm newborns born between 26-34 weeks of gestational age
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Amiens University Hospital
Amiens, Picardie, 80054
Pierre Tourneux, MD, +33 3 22 66 82 86, tourneux.pierre@chu-amiens.fr
Erwan STÉPHAN-BLANCHARD, Dr
About this study
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.
- Conditions
- Preterm Newborn
- Being tested
- questionary, Daily continuous recording of radiofrequency exposure levels, Follow-up of daily infants clinical parameters, recording of cerebral (EEG), autonomic nervous (ECG) activity
- Keywords
- preterm newborn, radiofrequencies, central and peripheral nervous systems
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionaryOther
Parental questionnaire on pregnancy history and environmental exposure
Daily continuous recording of radiofrequency exposure levelsOther
Daily continuous recording of radiofrequency exposure levels (1 week) by positioning a dosimeter close to the incubator
Follow-up of daily infants clinical parametersOther
Follow-up of daily infants clinical parameters
recording of cerebral (EEG)Other
recording of cerebral (EEG)
autonomic nervous (ECG) activityOther
autonomic nervous (ECG) activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of the spectral power in the α band (8-12 Hz) of the EEG
The spectral power in the α band (8-12 Hz) of the EEG
Measured: one week
Secondary outcomes (1)
variation of the spectral power in the delta (δ, 0.5-4 Hz) of the EEG
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start20 Feb 2024
- Primary completionSep 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm NewbornStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Brest, Hospices Civils de Lyon, University Hospital, Strasbourg, France, University Hospital, Toulouse
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281093
- Sponsor's protocol ID
- PI2022_843_0089
- Acronym
- CHARLINE
- Status last verified
- Mar 2024
- First submitted
- 20 Feb 2024
- Last updated
- 13 Mar 2024
- 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 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Fields in Neonatology: Exposure and Impact on the Nervous System
- ClinicalTrials.gov ID
- NCT06281093
- Acronym / sponsor ID
- CHARLINE / PI2022_843_0089
- Conditions
- Preterm Newborn
- Keywords
- preterm newborn, radiofrequencies, central and peripheral nervous systems
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- University Hospital, Brest, Hospices Civils de Lyon, University Hospital, Strasbourg, France, University Hospital, Toulouse
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 28 Feb 2024 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 1 day to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- preterm newborns born between 26-34 weeks of gestational age
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| questionaryParental questionnaire on pregnancy history and environmental exposure | Other | – |
| Daily continuous recording of radiofrequency exposure levelsDaily continuous recording of radiofrequency exposure levels (1 week) by positioning a dosimeter close to the incubator | Other | – |
| Follow-up of daily infants clinical parametersFollow-up of daily infants clinical parameters | Other | – |
| recording of cerebral (EEG)recording of cerebral (EEG) | Other | – |
| autonomic nervous (ECG) activityautonomic nervous (ECG) activity | Other | – |
Primary outcome
Variation of the spectral power in the α band (8-12 Hz) of the EEG
Time frame: one week
The spectral power in the α band (8-12 Hz) of the EEG
1 secondary outcome
variation of the spectral power in the delta (δ, 0.5-4 Hz) of the EEG
Time frame: one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing questionary, Daily continuous recording of radiofrequency exposure levels and Follow-up of daily infants clinical parameters in people with Preterm Newborn, 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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 13 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erwan STÉPHAN-BLANCHARD, Dr (03 22 82 78 65, erwan.stephan@u-picardie.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of the spectral power in the α band (8-12 Hz) of the EEG (time frame: one week). 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 13 Mar 2024.