Multimodal Analysis of Early Biomarkers of the Impacts of Perinatal Asphyxia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1+
SponsorCentre Hospitalier Universitaire, Amiens
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Full-term newborn not meeting inclusion criteria
Trial design
Design model
Parallel
Treatments tested in this trial
EEG
Deviceelectroencephalogram
Treatment groups
280 Participants
are divided into 3 treatment groupsGroup A: Non-Perinatal AsphyxiaActive comparator 1 intervention
Group B: At-Risk Perinatal AsphyxiaActive comparator 1 intervention
Group C: Confirmed Perinatal AsphyxiaActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 months2
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 monthsSecondary outcomes
1
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 months2
Identification of EEG markers of PA
EEG is Electroencephalography
Time frame
at 18 months3
correlation between biochemical, protein, and EEG markers
Time frame
at 18 months4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov
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