Multimodal Analysis of Early Biomarkers of the Impacts of Perinatal Asphyxia (Neurobiom)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Biomarkers; Asphyxia; EEG; Neonate; Eye Tracking
• Intervention / Treatment: Device: EEG

• Study Type: Interventional
• Enrollment (Estimated): 280
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fabrice Wallois, Pr; Phone Number: 33+3 22 087775; Email: wallois.fabrice@chu-amiens.fr

Study Locations

• France
  • Amiens, France, 80054
    • CHU Amiens
    • Contact: Fabrice WALLOIS, MD, PhD; Phone Number: 03 22 08 77 77; Email: wallois.fabrice@chu-amiens.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Non-Perinatal Asphyxia; 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; electroencephalogram
Active Comparator: At-Risk Perinatal Asphyxia; 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; electroencephalogram
Active Comparator: Confirmed Perinatal Asphyxia; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of biochemical and protein markers of PA	biochemical and protein markers are oxygen level, pH, lactates, glucose, IL-1β, IL-6, TNF-α	at 18 months
Identification of EEG markers of PA	EEG is Electroencephalography	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	Analyze correlations between biochemical, protein, and EEG markers at birth and behavioral and neural measurements at 18 months.	at 18 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: July 9, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Biomarkers; EEG; Neonate; asphyxia; Eye tracking; anoxo ischemia
• Additional Relevant MeSH Terms: Wounds and Injuries; Pathologic Processes; Death; Pathological Conditions, Signs and Symptoms; Asphyxia; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Electrodiagnosis; Electroencephalography
• Other Study ID Numbers: PI2025_843_0179

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No