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Biomarkers And Neurological Outcome in Neonates 2 — BANON2  

Asphyxia Neonatorum Clinical Trial

Official title:
Validation of Biomarkers of Adverse Neurologic Outcome in Newborns at Risk for Perinatal Brain Injury - Study on Neuro-developmental Follow-up at 2 Years A Prospective Multicenter Observational Study for Development of a Diagnostic Test

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04714775
Study type Observational
Source InfanDx AG
Contact Ron Meyer
Phone +49 172 266 5552
Email ron.meyer@infandx.com
Status Recruiting
Phase
Start date February 5, 2019
Completion date December 2021
View Details
See also
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