An interventional study of EEG in Neonate, Asphyxia and EEG, sponsored by Centre Hospitalier Universitaire, Amiens. Not yet recruiting at 1 site in France. Open to participants aged 1 Day and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Centre Hospitalier Universitaire, Amiens · Not applicable, Interventional, and Other
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.
The non-PA cohort includes:
No major complications should occur during pregnancy or delivery.
The at-risk PA cohort includes newborns who are:
Classified as such based on biochemical markers identified in WP1 (see WP1).
The PA cohort includes:
Exclusion Criteria:
* 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.
Device: EEG
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)
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
Device: EEG
electroencephalogram
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
Time frame: 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
Time frame: at 18 months
Identification of biochemical and protein markers of PA
biochemical and protein markers are oxygen level, pH, lactates, glucose, IL-1β, IL-6, TNF-α
Time frame: at 18 months
Identification of EEG markers of PA
EEG is Electroencephalography
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
Analyze correlations between biochemical, protein, and EEG markers at birth and behavioral and neural measurements at 18 months.
Time frame: at 18 months
Plan to share: No
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Centre Hospitalier Universitaire, Amiens