Biomarkers And Neurological Outcome in Neonates 2 (BANON2)

January 18, 2021 updated by: InfanDx AG

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

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aschaffenburg, Germany, 63739
        • Recruiting
        • Städtisches Krankenhaus Aschaffenburg
        • Contact:
        • Principal Investigator:
          • Christian Wieg, Dr. med.
      • Dresden, Germany, 01307
        • Recruiting
        • Universitätsklinikum Carl Gustav Carus, Neonatologie
        • Contact:
        • Sub-Investigator:
          • Stefan Winkler, Dr. med.
      • Essen, Germany, 45147
        • Recruiting
        • Uniklinik Essen
        • Contact:
        • Principal Investigator:
          • Ursula Felderhoff, Prof.
      • Hamburg, Germany, 22149
        • Recruiting
        • Marienkrankenhaus
        • Contact:
        • Principal Investigator:
          • Lutz Koch, Prof.
      • Heidelberg, Germany, 69120
      • Karlsruhe, Germany, 76133
        • Recruiting
        • Städtisches Klinikum Karlsruhe, Klinik für Kinder- und Jugendmedizin
        • Contact:
        • Principal Investigator:
          • Joachim Kühr, Prof.
      • München, Germany, 80638
        • Recruiting
        • Klinik für Kinder- und Jugendmedizin, Klinikum Dritter Orden,
        • Contact:
        • Principal Investigator:
          • Jochen Peters, Prof.
      • München, Germany, 81377
        • Recruiting
        • Universitäts Kinderkrankenhaus und Perinatal Zentrum
        • Contact:
        • Principal Investigator:
          • Andreas Flemmer, Prof.
      • Passau, Germany, 94032
      • Regensburg, Germany, 93049
      • Tübingen, Germany, 72076
        • Recruiting
        • Universitätsklinikum Tübingen, Universiätsklinik für Kinder- u. Jugendmedizin
        • Contact:
        • Principal Investigator:
          • Axel Franz, Prof.
  • Turkey
      • Adana, Turkey, 01330
        • Recruiting
        • Çukurova University Hospital
        • Contact:
          • Hacer Yapicioglu-Yildizdas, Prof.
        • Principal Investigator:
          • Hacer Yapicioglu-Yildizdas, Prof.
      • Elazığ, Turkey, 23040
        • Recruiting
        • University of Firat, Department of Pediatrics
        • Contact:
          • Erdal Taskin, Prof.
        • Principal Investigator:
          • Erdal Taskin, Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children, who had been enrolled in the BANON study immediately after birth because they had been suspected to be at risk for perinatal brain injury (hypoxic-ischemic encephalopathy, HIE) and/or evaluated for hypothermia therapy.

Description

Inclusion Criteria:

  • Infants previously enrolled in BANON study

Exclusion Criteria:

  • Missing valid written informed parental consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

InfanDx AG

Collaborators

University Hospital Tuebingen

Investigators

  • Study Director: Ron Meyer, InfanDx AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2019

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

January 13, 2021

First Submitted That Met QC Criteria

January 15, 2021

First Posted (Actual)

January 19, 2021

Study Record Updates

Last Update Posted (Actual)

January 20, 2021

Last Update Submitted That Met QC Criteria

January 18, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BANON2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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