Premature BirthNEURONAUXNCT03677908
Plasticity of Neonatal Neuronal Networks Temporal Theta Activity, the First Endogenous
An observational study of Premature Birth, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Temporal theta slow-wave activity (TTA-SW) in premature infants is a specific signature of the early development of temporal networks, as it is observed at the turning point between non-sensory driven spontaneous local processing and cortical network functioning. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Premature Birth
- What is being tested?
- ElectroEncephaloGraphy
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2016to 1 Jan 2017
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 28 healthy premature infants follow-up between the Gestational Ages of 26 and 32 wGA between December 2014 and June 2015. These infants were divided into two groups accord- ing to age (26-30 wGA and 30-32 wGA).
Who may be able to join
- healthy premature infants
- Gestational Ages of 26 and 32 wGA
Who cannot join
- unhealthy premature infants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Plasticity of Neonatal Neuronal Networks in Very Premature Infants: Source Localization of Temporal Theta Activity, the First Endogenous Neural Biomarker, in Temporoparietal Areas
Temporal theta slow-wave activity (TTA-SW) in premature infants is a specific signature of the early development of temporal networks, as it is observed at the turning point between non-sensory driven spontaneous local processing and cortical network functioning. The role in development and the precise location of TTA-SW remain unknown. Previous studies have demonstrated that preterms from 28 weeks of gestational age (wGA) are able to discriminate phonemes and voice, supporting the idea of a prior genetic structural or activity-dependent fingerprint that would prepare the auditory network to compute auditory information at the onset of thalamocortical connectivity. They recorded TTA-SW in 26-32 wGA preterms. The rate of TTA-SW in response to click stimuli was evalu- ated using low-density EEG in 30 preterms. The sources of TTA-SW were localized by high-density EEG using different tissues conductivities, head models and mathematical models.
Read the detailed description
Temporal theta slow-wave activity (TTA-SW) in premature infants is a specific signature of the early development of temporal networks, as it is observed at the turning point between non-sensory driven spontaneous local processing and cortical network functioning. The role in development and the precise location of TTA-SW remain unknown. Previous studies have demonstrated that preterms from 28 weeks of gestational age (wGA) are able to discriminate phonemes and voice, supporting the idea of a prior genetic structural or activity-dependent fingerprint that would prepare the auditory network to compute auditory information at the onset of thalamocortical connectivity. They recorded TTA-SW in 26-32 wGA preterms. The rate of TTA-SW in response to click stimuli was evalu- ated using low-density EEG in 30 preterms.
- Conditions
- Premature Birth
- Being tested
- ElectroEncephaloGraphy
- Keywords
- Temporoparietal Areas, Neural Biomarker
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroEncephaloGraphyOther
Density ElectroEncephaloGraphy analysis
| Study group | Role | What they receive |
|---|---|---|
| 13 high | High-Density ElectroEncephaloGraphy analysis of 13 healthy premature infants Receives: Other: ElectroEncephaloGraphy | |
| 15 low | Low-Density ElectroEncephaloGraphy analysis of other 15 healthy premature infants Receives: Other: ElectroEncephaloGraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
specific temporal TTA-SW
The objective of this study is to evaluate the spatial organization of the specific Temporal theta slow-wave activity (TTA-SW) with the Low-Density Electroencephalography (LD-EEG) at an early stage of development in humans to demonstrate that TTA-SW were independent of auditory stimuli.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start1 Jul 2016
- Primary completion1 Jan 2017
- Study completion1 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabrice Wallois, PU-PH, Principal investigator, CHU AMIENS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03677908
- Sponsor's protocol ID
- PI2017_843_0048
- Acronym
- NEURONAUX
- Status last verified
- Jun 2026
- First submitted
- 14 Sep 2018
- Last updated
- 16 Jun 2026
- Results posted
- 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 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasticity of Neonatal Neuronal Networks in Very Premature Infants: Source Localization of Temporal Theta Activity, the First Endogenous Neural Biomarker, in Temporoparietal Areas
- ClinicalTrials.gov ID
- NCT03677908
- Acronym / sponsor ID
- NEURONAUX / PI2017_843_0048
- Conditions
- Premature Birth
- Keywords
- Temporoparietal Areas, Neural Biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 19 Sep 2018 (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.
Temporal theta slow-wave activity (TTA-SW) in premature infants is a specific signature of the early development of temporal networks, as it is observed at the turning point between non-sensory driven spontaneous local processing and cortical network functioning. The role in development and the precise location of TTA-SW remain unknown. Previous studies have demonstrated that preterms from 28 weeks of gestational age (wGA) are able to discriminate phonemes and voice, supporting the idea of a prior genetic structural or activity-dependent fingerprint that would prepare the auditory network to compute auditory information at the onset of thalamocortical connectivity. They recorded TTA-SW in 26-32 wGA preterms. The rate of TTA-SW in response to click stimuli was evalu- ated using low-density EEG in 30 preterms. The sources of TTA-SW were localized by high-density EEG using different tissues conductivities, head models and mathematical models.
Detailed description
Temporal theta slow-wave activity (TTA-SW) in premature infants is a specific signature of the early development of temporal networks, as it is observed at the turning point between non-sensory driven spontaneous local processing and cortical network functioning. The role in development and the precise location of TTA-SW remain unknown. Previous studies have demonstrated that preterms from 28 weeks of gestational age (wGA) are able to discriminate phonemes and voice, supporting the idea of a prior genetic structural or activity-dependent fingerprint that would prepare the auditory network to compute auditory information at the onset of thalamocortical connectivity. They recorded TTA-SW in 26-32 wGA preterms. The rate of TTA-SW in response to click stimuli was evalu- ated using low-density EEG in 30 preterms.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 13 high | – | Other: ElectroEncephaloGraphyHigh-Density ElectroEncephaloGraphy analysis of 13 healthy premature infants |
| 15 low | – | Other: ElectroEncephaloGraphyLow-Density ElectroEncephaloGraphy analysis of other 15 healthy premature infants |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 28 healthy premature infants follow-up between the Gestational Ages of 26 and 32 wGA between December 2014 and June 2015. These infants were divided into two groups accord- ing to age (26-30 wGA and 30-32 wGA).
Key inclusion criteria (2 listed)
- healthy premature infants
- Gestational Ages of 26 and 32 wGA
Key exclusion criteria (1 listed)
- unhealthy premature infants
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 |
|---|---|---|
| ElectroEncephaloGraphyDensity ElectroEncephaloGraphy analysis | Other | 13 high, 15 low |
Primary outcome
specific temporal TTA-SW
Time frame: 2 months
The objective of this study is to evaluate the spatial organization of the specific Temporal theta slow-wave activity (TTA-SW) with the Low-Density Electroencephalography (LD-EEG) at an early stage of development in humans to demonstrate that TTA-SW were independent of auditory stimuli.
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 16 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.
Fabrice Wallois, PU-PH 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?
An observational study of Premature Birth, 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 1 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 16 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?
specific temporal TTA-SW (time frame: 2 months). 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 16 Jun 2026.