Multimodal Analysis of Early Biomarkers of the Impacts of Perinatal Asphyxia

NCT07702500 | Not Yet Recruiting

• 1 other identifier: PI2025_843_0179
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonate; Asphyxia; EEG; Eye Tracking; Biomarkers

Keywords

Neonate; asphyxia; anoxo ischemia; EEG; Eye tracking; Biomarkers

Outcome Measures

Primary Outcomes (2)

• 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

  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

  at 18 months

Secondary Outcomes (4)

• Identification of biochemical and protein markers of PA

  at 18 months

• Identification of EEG markers of PA

  at 18 months

• 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

Study Arms (3)

Non-Perinatal Asphyxia

ACTIVE COMPARATOR

* 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

At-Risk Perinatal Asphyxia

ACTIVE COMPARATOR

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

Confirmed Perinatal Asphyxia

ACTIVE COMPARATOR

* 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

Interventions

EEG DEVICE

electroencephalogram

At-Risk Perinatal Asphyxia; Confirmed Perinatal Asphyxia; Non-Perinatal Asphyxia

Eligibility Criteria

• Age: 1 Day+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• Classified as such based on biochemical markers identified in WP1 (see WP1).
• Confirmed Perinatal Asphyxia Cohort:
• The PA cohort includes:
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80054, France

Location

MeSH Terms

Conditions

Asphyxia

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Central Study Contacts

Fabrice Wallois, Pr

CONTACT

33+3 22 087775; wallois.fabrice@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: July 14, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)