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Biomarkers And Neurological Outcome in Neonates 2

NCT ID: NCT04714775

Last Updated: 2021-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-05

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Asphyxia Neonatorum

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Infants previously enrolled in BANON study

Exclusion Criteria

* Missing valid written informed parental consent
Minimum Eligible Age

22 Months

Maximum Eligible Age

48 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role collaborator

InfanDx AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ron Meyer

Role: STUDY_DIRECTOR

InfanDx AG

Locations

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Städtisches Krankenhaus Aschaffenburg

Aschaffenburg, , Germany

Site Status RECRUITING

Universitätsklinikum Carl Gustav Carus, Neonatologie

Dresden, , Germany

Site Status RECRUITING

Uniklinik Essen

Essen, , Germany

Site Status RECRUITING

Marienkrankenhaus

Hamburg, , Germany

Site Status RECRUITING

Universitätsklinikum Heidelberg

Heidelberg, , Germany

Site Status RECRUITING

Städtisches Klinikum Karlsruhe, Klinik für Kinder- und Jugendmedizin

Karlsruhe, , Germany

Site Status RECRUITING

Klinik für Kinder- und Jugendmedizin, Klinikum Dritter Orden,

München, , Germany

Site Status RECRUITING

Universitäts Kinderkrankenhaus und Perinatal Zentrum

München, , Germany

Site Status RECRUITING

Kinderklinik Dritter Orden

Passau, , Germany

Site Status RECRUITING

Klinik St. Hedwig

Regensburg, , Germany

Site Status RECRUITING

Universitätsklinikum Tübingen, Universiätsklinik für Kinder- u. Jugendmedizin

Tübingen, , Germany

Site Status RECRUITING

Cukurova University Hospital

Adana, , Turkey (Türkiye)

Site Status RECRUITING

University of Firat, Department of Pediatrics

Elâzığ, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Germany Turkey (Türkiye)

Central Contacts

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Ron Meyer

Role: CONTACT

[email protected]
+49 172 266 5552

Carola Steins-Rang, Dr.

Role: CONTACT

[email protected]
+49 22129271405

Facility Contacts

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Christian Wieg, Dr. med.

Role: primary

[email protected]

Stefan Winkler, Dr. med.

Role: primary

[email protected]

Ursula Felderhoff, Prof.

Role: primary

[email protected]

Lutz Koch, Prof.

Role: primary

[email protected]

Johannes Pöschl, Prof.

Role: primary

[email protected]

Joachim Kühr, Prof.

Role: primary

[email protected]

Jochen Peters, Prof.

Role: primary

[email protected]

Andreas Flemmer, Prof.

Role: primary

[email protected]

Matthias Keller, Prof.

Role: primary

[email protected]

Jochen Kittel, Dr. med.

Role: primary

[email protected]

Axel Franz, Prof.

Role: primary

[email protected]

Hacer Yapicioglu-Yildizdas, Prof.

Role: primary

Erdal Taskin, Prof.

Role: primary

Other Identifiers

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BANON2

Identifier Type: -

Identifier Source: org_study_id

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