Biomarkers And Neurological Outcome in Neonates 2

Last updated: January 18, 2021
Sponsor: InfanDx AG
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04714775
BANON2
  • Ages 22-48
  • All Genders

Study Summary

Follow-up of participants of BANON1 study at age of at least 2 years. BANON1 (ClinicalTrials.gov ID: NCT03357250): Validation of biomarkers based on 24 months neuro-developmental outcome data in a human population for their ability to diagnose the severity of neonatal asphyxia. These biomarkers linked to asphyxia have been identified in animal studies and a preliminary human study.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Infants previously enrolled in BANON study

Exclusion

Exclusion Criteria:

  • Missing valid written informed parental consent

Study Design

Total Participants: 500
Study Start date:
February 05, 2019
Estimated Completion Date:
December 31, 2021

Study Description

Follow-Up on neuro-developmental status of Study participants of BANON1. BANON1 (ClinicalTrials.gov ID: NCT03357250): The aim of the study is to validate the application of combinations of several laboratory parameters in early postnatal blood samples, for identification of infants, who will suffer from early abnormal neonatal neurological outcome, in a population at risk. The population at risk is defined as term and late preterm (>36 weeks of gestation) human infants following perinatal hypoxia-ischemia with or without postnatal resuscitation, and where the combination of laboratory parameters is derived from a preliminary study performed in Turkey (AAMBI) using a metabolomics approach.

Connect with a study center

  • Städtisches Krankenhaus Aschaffenburg

    Aschaffenburg, 63739
    Germany

    Active - Recruiting

  • Universitätsklinikum Carl Gustav Carus, Neonatologie

    Dresden, 01307
    Germany

    Active - Recruiting

  • Uniklinik Essen

    Essen, 45147
    Germany

    Active - Recruiting

  • Marienkrankenhaus

    Hamburg, 22149
    Germany

    Active - Recruiting

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120
    Germany

    Active - Recruiting

  • Städtisches Klinikum Karlsruhe, Klinik für Kinder- und Jugendmedizin

    Karlsruhe, 76133
    Germany

    Active - Recruiting

  • Klinik für Kinder- und Jugendmedizin, Klinikum Dritter Orden,

    München, 80638
    Germany

    Active - Recruiting

  • Universitäts Kinderkrankenhaus und Perinatal Zentrum

    München, 81377
    Germany

    Active - Recruiting

  • Kinderklinik Dritter Orden

    Passau, 94032
    Germany

    Active - Recruiting

  • Klinik St. Hedwig

    Regensburg, 93049
    Germany

    Active - Recruiting

  • Universitätsklinikum Tübingen, Universiätsklinik für Kinder- u. Jugendmedizin

    Tübingen, 72076
    Germany

    Active - Recruiting

  • Cukurova University Hospital

    Adana, 01330
    Turkey

    Active - Recruiting

  • University of Firat, Department of Pediatrics

    Elazığ, 23040
    Turkey

    Active - Recruiting

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