NeonateNeurobiomNCT07702500
Multimodal Analysis of Early Biomarkers of the Impacts of Perinatal Asphyxia
A study testing EEG in people with Neonate and Asphyxia, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Current diagnostic methods rely primarily on clinical symptoms, supplemented by brain imaging and physiological tests. However, these signs of injury only become apparent once significant damage has occurred, thus delaying intervention and compromising the effectiveness of treatments. Read more about this study
- Who is it for?
- Ages 1 day and olderHealthy volunteers can take part
- What is being tested?
- EEG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2026to Dec 2029
- 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 1 day and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Non-Perinatal Asphyxia Cohort:
- The non-PA cohort includes:
- Full-term infants (born between 36 and 42 weeks of gestation), clinically "normal" and without PA. Infants must have birth weights within the normal range for their gestational age.
- Satisfactory Apgar scores at 1, 3, and 5 minutes, indicating good health.
- Meet specific biochemical biomarker criteria as defined by the study protocols.
- No major complications should occur during pregnancy or delivery.
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- At-Risk Perinatal Asphyxia Cohort:
- The at-risk PA cohort includes newborns who are:
- Identified by healthcare professionals as being at risk based on criteria that do not exceed the diagnostic thresholds for PA but whose combined assessment of maternal, fetal, and neonatal medical criteria suggests risk factors and early signs of potential PA,
- OR
- Classified as such based on biochemical markers identified in WP1 (see WP1).
- Confirmed Perinatal Asphyxia Cohort:
- The PA cohort includes:
- Newborns diagnosed with PA and treated with hypothermia. The inclusion criteria for this group allow for various modes of delivery, complications during pregnancy and delivery, and a range of gestational ages, as long as they meet the criteria for PA.
- Birth weight must be ≥ 1800 g.
- Apgar scores at 1, 3, and 5 minutes must indicate potential complications or difficulties.
- Specific biochemical markers indicative of PA must be present
Who cannot join
- Full-term newborn not meeting inclusion criteria
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
CHU Amiens
Amiens, 80054
Fabrice WALLOIS, MD, PhD, 03 22 08 77 77, wallois.fabrice@chu-amiens.fr
About this study
Current diagnostic methods rely primarily on clinical symptoms, supplemented by brain imaging and physiological tests. However, these signs of injury only become apparent once significant damage has occurred, thus delaying intervention and compromising the effectiveness of treatments. Therefore, there is a need to develop new markers to develop preventive measures for the consequences of perinatal asphyxia.
The primary objective is to compare cognitive and motor development at 18 months in three populations (PA, at risk of PA, and Control) defined on the basis of clinical, biological, and neural criteria.
- Conditions
- Neonate, Asphyxia, EEG, Eye Tracking, Biomarkers
- Being tested
- EEG
- Keywords
- Neonate, asphyxia, anoxo ischemia, EEG, Eye tracking, Biomarkers
- Medical subject headings
- Asphyxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEGDevice
electroencephalogram
| Study group | Role | What they receive |
|---|---|---|
| Non-Perinatal Asphyxia | Active comparator | * Full-term infants (born between 36 and 42 weeks of gestation), clinically "normal" and without PA. Infants must have birth weights within the normal range for their gestational age.
* Satisfactory Apgar scores at 1, 3, and 5 minutes, indicating good health.
* Meet specific biochemical biomarker criteria as defined by the study protocols.
* No major complications should occur during pregnancy or delivery. Receives: Device: EEG |
| At-Risk Perinatal Asphyxia | Active comparator | The at-risk PA cohort includes newborns who are:
* Identified by healthcare professionals as being at risk based on criteria that do not exceed the diagnostic thresholds for PA but whose combined assessment of maternal, fetal, and neonatal medical criteria suggests risk factors and early signs of potential PA,
* OR
* Classified as such based on biochemical markers identified in WP1 (see WP1) Receives: Device: EEG |
| Confirmed Perinatal Asphyxia | Active comparator | * Newborns diagnosed with PA and treated with hypothermia. The inclusion criteria for this group allow for various modes of delivery, complications during pregnancy and delivery, and a range of gestational ages, as long as they meet the criteria for PA.
* Birth weight must be ≥ 1800 g.
* Apgar scores at 1, 3, and 5 minutes must indicate potential complications or difficulties.
* Specific biochemical markers indicative of PA must be present Receives: Device: EEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
variation of Cognitive development in the three populations
variation of Cognitive development in the three populations (PA, at risk of PA, and Control) Cognitive development is determined with EEG, eye tracking and questionnaire
Measured: at 18 months
variation of motor development in the three populations
variation of motor development in the three populations (PA, at risk of PA, and Control) motor development is determined by mouvement analysis
Measured: at 18 months
Secondary outcomes (4)
Identification of biochemical and protein markers of PA
biochemical and protein markers are oxygen level, pH, lactates, glucose, IL-1β, IL-6, TNF-α
Measured: at 18 months
Identification of EEG markers of PA
EEG is Electroencephalography
Measured: at 18 months
correlation between biochemical, protein, and EEG markers
Measured: at 18 months
correlation between biochemical markers at birth and behavioral measurements at 18 months
Analyze correlations between biochemical, protein, and EEG markers at birth and behavioral and neural measurements at 18 months.
Measured: at 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study startOct 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeonateStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07702500
- Sponsor's protocol ID
- PI2025_843_0179
- Acronym
- Neurobiom
- Status last verified
- Jul 2026
- First submitted
- 18 Nov 2025
- Last updated
- 8 Sep 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 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Analysis of Early Biomarkers of the Impacts of Perinatal Asphyxia
- ClinicalTrials.gov ID
- NCT07702500
- Acronym / sponsor ID
- Neurobiom / PI2025_843_0179
- Conditions
- Neonate, Asphyxia, EEG, Eye Tracking, Biomarkers
- Keywords
- Neonate, asphyxia, anoxo ischemia, EEG, Eye tracking, Biomarkers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 14 Jul 2026 (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.
Current diagnostic methods rely primarily on clinical symptoms, supplemented by brain imaging and physiological tests. However, these signs of injury only become apparent once significant damage has occurred, thus delaying intervention and compromising the effectiveness of treatments. Therefore, there is a need to develop new markers to develop preventive measures for the consequences of perinatal asphyxia.
The primary objective is to compare cognitive and motor development at 18 months in three populations (PA, at risk of PA, and Control) defined on the basis of clinical, biological, and neural criteria.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-Perinatal Asphyxia | Active comparator | Device: EEG* Full-term infants (born between 36 and 42 weeks of gestation), clinically "normal" and without PA. Infants must have birth weights within the normal range for their gestational age. * Satisfactory Apgar scores at 1, 3, and 5 minutes, indicating good health. * Meet specific biochemical biomarker criteria as defined by the study protocols. * No major complications should occur during pregnancy or delivery. |
| At-Risk Perinatal Asphyxia | Active comparator | Device: EEGThe at-risk PA cohort includes newborns who are: * Identified by healthcare professionals as being at risk based on criteria that do not exceed the diagnostic thresholds for PA but whose combined assessment of maternal, fetal, and neonatal medical criteria suggests risk factors and early signs of potential PA, * OR * Classified as such based on biochemical markers identified in WP1 (see WP1) |
| Confirmed Perinatal Asphyxia | Active comparator | Device: EEG* Newborns diagnosed with PA and treated with hypothermia. The inclusion criteria for this group allow for various modes of delivery, complications during pregnancy and delivery, and a range of gestational ages, as long as they meet the criteria for PA. * Birth weight must be ≥ 1800 g. * Apgar scores at 1, 3, and 5 minutes must indicate potential complications or difficulties. * Specific biochemical markers indicative of PA must be present |
Who may qualify
- Ages
- 1 day and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- Non-Perinatal Asphyxia Cohort:
- Full-term infants (born between 36 and 42 weeks of gestation), clinically "normal" and without PA. Infants must have birth weights within the normal range for their gestational age.
- Satisfactory Apgar scores at 1, 3, and 5 minutes, indicating good health.
- Meet specific biochemical biomarker criteria as defined by the study protocols.
- No major complications should occur during pregnancy or delivery.
Key exclusion criteria (1 listed)
- Full-term newborn not meeting inclusion criteria
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 |
|---|---|---|
| EEGelectroencephalogram | Device | At-Risk Perinatal Asphyxia, Confirmed Perinatal Asphyxia, Non-Perinatal Asphyxia |
Primary outcome
variation of Cognitive development in the three populations
Time frame: at 18 months
variation of Cognitive development in the three populations (PA, at risk of PA, and Control) Cognitive development is determined with EEG, eye tracking and questionnaire
variation of motor development in the three populations
Time frame: at 18 months
variation of motor development in the three populations (PA, at risk of PA, and Control) motor development is determined by mouvement analysis
4 secondary outcomes
Identification of biochemical and protein markers of PA
Time frame: at 18 months
Identification of EEG markers of PA
Time frame: at 18 months
correlation between biochemical, protein, and EEG markers
Time frame: at 18 months
correlation between biochemical markers at birth and behavioral measurements at 18 months
Time frame: at 18 months
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 8 Sep 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.
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 in people with Neonate and Asphyxia, 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 17 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: opening soon, as of the sponsor's last update on 8 Sep 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?
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+3 22 087775, wallois.fabrice@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
variation of Cognitive development in the three populations (time frame: at 18 months). The study lists 2 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 8 Sep 2026.