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NCT Number: NCT07702500

Multimodal Analysis of Early Biomarkers of the Impacts of Perinatal Asphyxia

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.

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Key information

Age range

1 day and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EEG

Device

electroencephalogram

Primary outcomes

  1. variation of Cognitive development in the three populations

    Time frame: 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

  2. variation of motor development in the three populations

    Time frame: 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

Secondary outcomes

  1. Identification of biochemical and protein markers of PA

    Time frame: at 18 months

    biochemical and protein markers are oxygen level, pH, lactates, glucose, IL-1β, IL-6, TNF-α

  2. Identification of EEG markers of PA

    Time frame: at 18 months

    EEG is Electroencephalography

  3. correlation between biochemical, protein, and EEG markers

    Time frame: at 18 months

  4. correlation between biochemical markers at birth and behavioral measurements at 18 months

    Time frame: at 18 months

    Analyze correlations between biochemical, protein, and EEG markers at birth and behavioral and neural measurements at 18 months.

Study contacts

Contact information is provided by the study sponsor or research team.

Fabrice Wallois, Pr

CONTACT

[email protected]

33+3 22 087775

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: Neurobiom

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jul 14, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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