Asphyxia, Biomarkers, EEG, Eye Tracking, Neonate
Conditions
Keywords
Neonate, asphyxia, anoxo ischemia, EEG, Eye tracking, Biomarkers
Brief 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. 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.
Interventions
DEVICEEEG
electroencephalogram
Sponsors
Centre Hospitalier Universitaire, Amiens
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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. * 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
Exclusion criteria
* Full-term newborn not meeting inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| variation of Cognitive development in the three populations | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Identification of biochemical and protein markers of PA | at 18 months | biochemical and protein markers are oxygen level, pH, lactates, glucose, IL-1β, IL-6, TNF-α |
| Identification of EEG markers of PA | at 18 months | EEG is Electroencephalography |
| correlation between biochemical, protein, and EEG markers | at 18 months | — |
| correlation between biochemical markers at birth and behavioral measurements at 18 months | at 18 months | Analyze correlations between biochemical, protein, and EEG markers at birth and behavioral and neural measurements at 18 months. |
Countries
France
Contacts
CONTACTFabrice Wallois, Pr
Outcome results
None listed