Multimodal Analysis of Early Biomarkers of the Impacts of Perinatal Asphyxia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EEG.
- Who it may be relevant to
- Registry conditions: Neonate, Asphyxia, EEG, Eye Tracking. Basic parameters: from 1 Day · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Device EEG
electroencephalogram
Primary outcome measures
- variation of Cognitive development in the three populations [Time frame: at 18 months]
- variation of motor development in the three populations [Time frame: at 18 months]
Secondary outcome measures (4)
- Identification of biochemical and protein markers of PA [Time frame: at 18 months]
- Identification of EEG markers of PA [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 [Time frame: at 18 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- CHU Amiens — Amiens
Identifiers
NCT: NCT07702500 · PI2025_843_0179