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

3 september 2026 uppdaterad av: Centre Hospitalier Universitaire, Amiens

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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

280

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: 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.
Enhet: EEG
electroencephalogram
Aktiv komparator: 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)
Enhet: EEG
electroencephalogram
Aktiv komparator: 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
Enhet: EEG
electroencephalogram

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
variation of Cognitive development in the three populations
Tidsram: 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
at 18 months
variation of motor development in the three populations
Tidsram: 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
at 18 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Identification of biochemical and protein markers of PA
Tidsram: at 18 months
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
Tidsram: at 18 months
EEG is Electroencephalography
at 18 months
correlation between biochemical, protein, and EEG markers
Tidsram: at 18 months
at 18 months
correlation between biochemical markers at birth and behavioral measurements at 18 months
Tidsram: at 18 months
Analyze correlations between biochemical, protein, and EEG markers at birth and behavioral and neural measurements at 18 months.
at 18 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Centre Hospitalier Universitaire, Amiens

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 oktober 2026

Primärt slutförande (Beräknad)

1 juni 2028

Avslutad studie (Beräknad)

1 december 2029

Studieregistreringsdatum

Först inskickad

18 november 2025

Först inskickad som uppfyllde QC-kriterierna

9 juli 2026

Första postat (Faktisk)

14 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

8 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 september 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • PI2025_843_0179

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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