Biomarkers And Neurological Outcome in Neonates 2

Asphyxia Neonatorum Clinical Trial

— BANON2  

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 Details — Status: Recruiting

Administrative data

• NCT number: NCT04714775
• Other study ID #: BANON2
• Status: Recruiting
• Start date: February 5, 2019
• Est. completion date: December 2021

Study information

• Verified date: January 2021
• Source: InfanDx AG
• Contact: Ron Meyer
• Phone: +49 172 266 5552
• Email: ron.meyer[@]infandx.com
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Months to 48 Months

Eligibility

Inclusion Criteria:

• Infants previously enrolled in BANON study

Exclusion Criteria:

• Missing valid written informed parental consent

Related Conditions & MeSH terms

• Asphyxia
• Asphyxia Neonatorum

Locations

Country	Name	City	State
Germany	Städtisches Krankenhaus Aschaffenburg	Aschaffenburg
Germany	Universitätsklinikum Carl Gustav Carus, Neonatologie	Dresden
Germany	Uniklinik Essen	Essen
Germany	Marienkrankenhaus	Hamburg
Germany	Universitätsklinikum Heidelberg	Heidelberg
Germany	Städtisches Klinikum Karlsruhe, Klinik für Kinder- und Jugendmedizin	Karlsruhe
Germany	Klinik für Kinder- und Jugendmedizin, Klinikum Dritter Orden,	München
Germany	Universitäts Kinderkrankenhaus und Perinatal Zentrum	München
Germany	Kinderklinik Dritter Orden	Passau
Germany	Klinik St. Hedwig	Regensburg
Germany	Universitätsklinikum Tübingen, Universiätsklinik für Kinder- u. Jugendmedizin	Tübingen
Turkey	Cukurova University Hospital	Adana
Turkey	University of Firat, Department of Pediatrics	Elazig

Sponsors (2)

Lead Sponsor	Collaborator
InfanDx AG	University Hospital Tuebingen

Countries where clinical trial is conducted

Germany,  Turkey, 

Outcome

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