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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-Perinatal Asphyxia | Active Comparator |
|
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| At-Risk Perinatal Asphyxia | Active Comparator | The at-risk PA cohort includes newborns who are:
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| Confirmed Perinatal Asphyxia | Active Comparator |
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EEG | Device | electroencephalogram |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | at 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Identification of biochemical and protein markers of PA | biochemical and protein markers are oxygen level, pH, lactates, glucose, IL-1β, IL-6, TNF-α | at 18 months |
| Identification of EEG markers of PA |
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Inclusion Criteria:
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.
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).
The PA cohort includes:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fabrice Wallois, Pr | Contact | 33+3 22 087775 | wallois.fabrice@chu-amiens.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens | Amiens | 80054 | France |
|
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| ID | Term |
|---|---|
| D001237 | Asphyxia |
| ID | Term |
|---|---|
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D004569 | Electroencephalography |
| ID | Term |
|---|---|
| D003943 | Diagnostic Techniques, Neurological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
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EEG is Electroencephalography
| at 18 months |
| correlation between biochemical, protein, and EEG markers | 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. | at 18 months |