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
Sex
ALL
Min age
1 Day
Max age
—
Healthy volunteers
Accepted
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
Primary outcome measure(s)
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
Trial sites (1)
Facility
City
Region
Status
CHU Amiens
Amiens
France
More Centre Hospitalier Universitaire, Amiens trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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