Time PerceptionPremaTempoNCT04270734
Neural Signatures of Processing the Temporal Features of Auditory Events: From Preterm Infancy to Adulthood
A study testing EEG and NIRS in people with Time Perception and EEG, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Premature neonates are able to discriminate phonemes and voice from 28wGA at a time the neuronal network establish contact between the environment and the cortical neurones. In the present monocentric study the investigators will analyse the response of the cortical network in premature aged between 25 and 36 wGA in… Read more about this study
- Who is it for?
- Ages 0 days to 1 day
- Conditions the study is for
- Time Perception, EEG, Premature Neonates
- What is being tested?
- EEG and NIRS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2020to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 0 days to 1 day
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- full term neonates between 25 and 36 weeks gestational age
Who cannot join
- Neonates outside the age range
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens
Amiens, 80054
Fabrice Wallois, Pr, (33)322087775, fabrice.wallois@u-picardie.fr
Guy Kongolo, Pr, (33)322455877, kongolo.guy@chu-amiens.fr
About this study
Premature neonates are able to discriminate phonemes and voice from 28wGA at a time the neuronal network establish contact between the environment and the cortical neurones. In the present monocentric study the investigators will analyse the response of the cortical network in premature aged between 25 and 36 wGA in response to auditory stimuli using High Resolution Electroencephalography and High Density Near Infrared Spectroscopy.
Read the detailed description
Neurodevelopmental disorders may be related to functional or structural disruption of the neuronal network organization at an early stage or later in the course of development. The disruption of the initial set-up could partially explain the prevalence of neurodevelopmental risks due to prematurity. The development period between 25 and 33 wGA corresponds to the period of very great prematurity and represents a key period of neurodevelopment in terms of structural and functional establishment of neuronal networks. One way to address the functionality of the neuronal networks is to evaluate the neural response to the exogenous stimuli and to interpret the mechanisms and the developmental status of the network in their ability to develop appropriate responses.
- Conditions
- Time Perception, EEG, Premature Neonates, Discrimination
- Being tested
- EEG, NIRS
- Keywords
- time perception, rhythm, EEG, fNIRS, ERP, premature neonates, discrimination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEGProcedure or surgery
Response of the cortical network in premature aged between 25 and 36 wGA in response to auditory stimuli using High Resolution Electroencephalography will be performed
NIRSProcedure or surgery
Response of the cortical network in premature aged between 25 and 36 wGA in response to auditory stimuli using High Density Near Infrared Spectroscopy will be performed
| Study group | Role | What they receive |
|---|---|---|
| normal 25-36 gestational week preterm infant | Active comparator | Not described Receives: Procedure: EEG; Procedure: NIRS |
| 25-36 gestational week preterm infant with IVH | Experimental | 25-36 gestational week preterm infant with Intraventricular haemorrhages (IVH) Receives: Procedure: EEG; Procedure: NIRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure at which age the ability to discriminate time features occurs in premature neonates with Matlab Friedtrip toolbox
measure at which age the ability to discriminate time features occurs in premature neonates. For the analysis of discrimination, the investigators will use cluster analysis as implemented in the Matlab Friedtrip toolbox.
Measured: at day 0
Secondary outcomes (1)
variation of the ability to discriminate time features between the IVH and normal preterm groups with BESA statistical tools
variation of the ability to discriminate time features between the IVH and normal preterm groups. For the analysis of time-frequency responses, the investigators will use cluster randomization procedures as implemented in the BESA statistical tools.
Measured: at day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start1 Feb 2020
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Time PerceptionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ghilda Ghostine, MD, Principal investigator, CHU AmiensGuy Kongolo, MD, Principal investigator, CHU AmiensSabrina Goudjil, MD, Principal investigator, CHU AmiensAndré Léké, MD, Principal investigator, CHU AmiensChristèle Chazal, MD, Principal investigator, CHU AmiensPierre Tourneux, Pr, Principal investigator, CHU AmiensCoralie Degorre, MD, Principal investigator, CHU AmiensEmilie Bourel, MD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04270734
- Sponsor's protocol ID
- PI2019_843_0041
- Acronym
- PremaTempo
- Status last verified
- Jun 2025
- First submitted
- 7 Feb 2020
- Last updated
- 10 Jun 2025
- 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 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Signatures of Processing the Temporal Features of Auditory Events: From Preterm Infancy to Adulthood
- ClinicalTrials.gov ID
- NCT04270734
- Acronym / sponsor ID
- PremaTempo / PI2019_843_0041
- Conditions
- Time Perception, EEG, Premature Neonates, Discrimination
- Keywords
- time perception, rhythm, EEG, fNIRS, ERP, premature neonates, discrimination
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 17 Feb 2020 (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.
Premature neonates are able to discriminate phonemes and voice from 28wGA at a time the neuronal network establish contact between the environment and the cortical neurones. In the present monocentric study the investigators will analyse the response of the cortical network in premature aged between 25 and 36 wGA in response to auditory stimuli using High Resolution Electroencephalography and High Density Near Infrared Spectroscopy.
Detailed description
Neurodevelopmental disorders may be related to functional or structural disruption of the neuronal network organization at an early stage or later in the course of development. The disruption of the initial set-up could partially explain the prevalence of neurodevelopmental risks due to prematurity. The development period between 25 and 33 wGA corresponds to the period of very great prematurity and represents a key period of neurodevelopment in terms of structural and functional establishment of neuronal networks. One way to address the functionality of the neuronal networks is to evaluate the neural response to the exogenous stimuli and to interpret the mechanisms and the developmental status of the network in their ability to develop appropriate responses.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal 25-36 gestational week preterm infant | Active comparator | Procedure: EEG, Procedure: NIRS |
| 25-36 gestational week preterm infant with IVH | Experimental | Procedure: EEG, Procedure: NIRS25-36 gestational week preterm infant with Intraventricular haemorrhages (IVH) |
Who may qualify
- Ages
- 0 days to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- full term neonates between 25 and 36 weeks gestational age
Key exclusion criteria (1 listed)
- Neonates outside the age range
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 |
|---|---|---|
| EEGResponse of the cortical network in premature aged between 25 and 36 wGA in response to auditory stimuli using High Resolution Electroencephalography will be performed | Procedure or surgery | 25-36 gestational week preterm infant with IVH, normal 25-36 gestational week preterm infant |
| NIRSResponse of the cortical network in premature aged between 25 and 36 wGA in response to auditory stimuli using High Density Near Infrared Spectroscopy will be performed | Procedure or surgery | 25-36 gestational week preterm infant with IVH, normal 25-36 gestational week preterm infant |
Primary outcome
measure at which age the ability to discriminate time features occurs in premature neonates with Matlab Friedtrip toolbox
Time frame: at day 0
measure at which age the ability to discriminate time features occurs in premature neonates. For the analysis of discrimination, the investigators will use cluster analysis as implemented in the Matlab Friedtrip toolbox.
1 secondary outcome
variation of the ability to discriminate time features between the IVH and normal preterm groups with BESA statistical tools
Time frame: at day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- 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.
Ghilda Ghostine, MD principal investigator
CHU Amiens
Guy Kongolo, MD principal investigator
CHU Amiens
Sabrina Goudjil, 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 EEG and NIRS in people with Time Perception and EEG, 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 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: looking for participants now, as of the sponsor's last update on 10 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabrice Wallois, Pr ((33)322087775, fabrice.wallois@u-picardie.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure at which age the ability to discriminate time features occurs in premature neonates with Matlab Friedtrip toolbox (time frame: at day 0). 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 10 Jun 2025.