Biomarkers And Neurological Outcome in Neonates 2

• Conditions: Asphyxia Neonatorum

• Registration Number: NCT04714775
• Lead Sponsor: InfanDx AG

Brief 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.

Detailed 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 Timeline

• Study Start: 2019-02-05
• Status Verified: 2021-01
• Study First Submitted: 2021-01-13
• Study First Submitted QC: 2021-01-15
• Last Update Submitted: 2021-01-18
• Study First Posted: 2021-01-19
• Last Update Posted: 2021-01-20
• Primary Completion: 2021-06
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Infants previously enrolled in BANON study

Exclusion Criteria

• Missing valid written informed parental consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
participants with normal neuro-developmental status	up to 42 month age	all infants with normal neuro-developmental status
participants with potentially abnormal neuro-developmental status	up to 42 month age	All infants who do not fulfill outcomes 1, 3 or 4
participants with abnormal neuro-developmental status - HIE	up to 42 month age	Presence of adverse 2 years neuro-developmental outcome likely attributable to perinatal hypoxic-ischemic brain injury
participants with abnormal neuro-developmental status - non-HIE	up to 42 month age	Presence of adverse 2 years neuro-developmental outcome not attributable to perinatal hypoxic-ischemic brain injury

Trial Locations

Locations (13)

Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

Universitätsklinikum Tübingen, Universiätsklinik für Kinder- u. Jugendmedizin; 🇩🇪 Tübingen, Germany

Universitäts Kinderkrankenhaus und Perinatal Zentrum; 🇩🇪 München, Germany

Kinderklinik Dritter Orden; 🇩🇪 Passau, Germany

Marienkrankenhaus; 🇩🇪 Hamburg, Germany

Uniklinik Essen; 🇩🇪 Essen, Germany

Städtisches Klinikum Karlsruhe, Klinik für Kinder- und Jugendmedizin; 🇩🇪 Karlsruhe, Germany

Klinik für Kinder- und Jugendmedizin, Klinikum Dritter Orden,; 🇩🇪 München, Germany

Städtisches Krankenhaus Aschaffenburg; 🇩🇪 Aschaffenburg, Germany

Universitätsklinikum Carl Gustav Carus, Neonatologie; 🇩🇪 Dresden, Germany

Klinik St. Hedwig; 🇩🇪 Regensburg, Germany

Cukurova University Hospital; 🇹🇷 Adana, Turkey

University of Firat, Department of Pediatrics; 🇹🇷 Elazığ, Turkey