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Biomarkers And Neurological Outcome in Neonates 2 (BANON2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04714775
Recruitment Status : Recruiting
First Posted : January 19, 2021
Last Update Posted : January 20, 2021
Sponsor:
Collaborator:
University Hospital Tuebingen
Information provided by (Responsible Party):
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.

Condition or disease
Asphyxia Neonatorum

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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : February 5, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. participants with normal neuro-developmental status [ Time Frame: up to 42 month age ]
    all infants with normal neuro-developmental status

  2. 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

  3. 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

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Months to 48 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • Infants previously enrolled in BANON study

Exclusion Criteria:

  • Missing valid written informed parental consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04714775


Contacts
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Contact: Ron Meyer +49 172 266 5552 ron.meyer@infandx.com
Contact: Carola Steins-Rang, Dr. +49 22129271405 carola.steins-rang@infandx.com

Locations
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Germany
Städtisches Krankenhaus Aschaffenburg Recruiting
Aschaffenburg, Germany, 63739
Contact: Christian Wieg, Dr. med.       christian.wieg@klinikum-ab-alz.de   
Principal Investigator: Christian Wieg, Dr. med.         
Universitätsklinikum Carl Gustav Carus, Neonatologie Recruiting
Dresden, Germany, 01307
Contact: Stefan Winkler, Dr. med.       stefan.winkler@uniklinikum-dresden.de   
Sub-Investigator: Stefan Winkler, Dr. med.         
Uniklinik Essen Recruiting
Essen, Germany, 45147
Contact: Ursula Felderhoff, Prof.       ursula.felderhoff@uk-essen.de   
Principal Investigator: Ursula Felderhoff, Prof.         
Marienkrankenhaus Recruiting
Hamburg, Germany, 22149
Contact: Lutz Koch, Prof.       l.koch@KKH-Wilhelmstift.de   
Principal Investigator: Lutz Koch, Prof.         
Universitätsklinikum Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Johannes Pöschl, Prof.       johannes.poeschl@med.uni-heidelberg.de   
Principal Investigator: Johannes Pöschl, Prof.         
Städtisches Klinikum Karlsruhe, Klinik für Kinder- und Jugendmedizin Recruiting
Karlsruhe, Germany, 76133
Contact: Joachim Kühr, Prof.       Joachim.Kuehr@klinikum-karlsruhe.de   
Principal Investigator: Joachim Kühr, Prof.         
Klinik für Kinder- und Jugendmedizin, Klinikum Dritter Orden, Recruiting
München, Germany, 80638
Contact: Jochen Peters, Prof.       J.Peters@dritter-orden.de   
Principal Investigator: Jochen Peters, Prof.         
Universitäts Kinderkrankenhaus und Perinatal Zentrum Recruiting
München, Germany, 81377
Contact: Andreas Flemmer, Prof.       andreas.flemmer@med.uni-muenchen.de   
Principal Investigator: Andreas Flemmer, Prof.         
Kinderklinik Dritter Orden Recruiting
Passau, Germany, 94032
Contact: Matthias Keller, Prof.       matthias.keller@kinderklinik-passau.de   
Principal Investigator: Matthias Keller, Prof.         
Klinik St. Hedwig Recruiting
Regensburg, Germany, 93049
Contact: Jochen Kittel, Dr. med.       Jochen.Kittel@barmherzige-regensburg.de   
Sub-Investigator: Jochen Kittel, Dr. med.         
Universitätsklinikum Tübingen, Universiätsklinik für Kinder- u. Jugendmedizin Recruiting
Tübingen, Germany, 72076
Contact: Axel Franz, Prof.       axel.franz@med.uni-tuebingen.de   
Principal Investigator: Axel Franz, Prof.         
Turkey
Cukurova University Hospital Recruiting
Adana, Turkey, 01330
Contact: Hacer Yapicioglu-Yildizdas, Prof.         
Principal Investigator: Hacer Yapicioglu-Yildizdas, Prof.         
University of Firat, Department of Pediatrics Recruiting
Elazığ, Turkey, 23040
Contact: Erdal Taskin, Prof.         
Principal Investigator: Erdal Taskin, Prof.         
Sponsors and Collaborators
InfanDx AG
University Hospital Tuebingen
Investigators
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Study Director: Ron Meyer InfanDx AG
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Responsible Party: InfanDx AG
ClinicalTrials.gov Identifier: NCT04714775    
Other Study ID Numbers: BANON2
First Posted: January 19, 2021    Key Record Dates
Last Update Posted: January 20, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by InfanDx AG:
Biomarkers
Asphyxia
Hypoxic ischemic encephalopathy
Additional relevant MeSH terms:
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Asphyxia Neonatorum
Asphyxia
Death
Pathologic Processes
Wounds and Injuries
Infant, Newborn, Diseases