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| Name | Class |
|---|---|
| University Hospital Tuebingen | OTHER |
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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.
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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| Measure | Description | Time Frame |
|---|---|---|
| participants with normal neuro-developmental status | all infants with normal neuro-developmental status | up to 42 month age |
| participants with potentially abnormal neuro-developmental status | All infants who do not fulfill outcomes 1, 3 or 4 | up to 42 month age |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ron Meyer | Contact | +49 172 266 5552 | ron.meyer@infandx.com | |
| Carola Steins-Rang, Dr. | Contact | +49 22129271405 | carola.steins-rang@infandx.com |
| Name | Affiliation | Role |
|---|---|---|
| Ron Meyer | InfanDx AG | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Städtisches Krankenhaus Aschaffenburg | Recruiting | Aschaffenburg | 63739 | Germany |
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| ID | Term |
|---|---|
| D001238 | Asphyxia Neonatorum |
| D001237 | Asphyxia |
| D020925 | Hypoxia-Ischemia, Brain |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003643 | Death |
| D010335 | Pathologic Processes |
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| Universitätsklinikum Carl Gustav Carus, Neonatologie | Recruiting | Dresden | 01307 | Germany |
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| Uniklinik Essen | Recruiting | Essen | 45147 | Germany |
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| Marienkrankenhaus | Recruiting | Hamburg | 22149 | Germany |
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| Universitätsklinikum Heidelberg | Recruiting | Heidelberg | 69120 | Germany |
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| Städtisches Klinikum Karlsruhe, Klinik für Kinder- und Jugendmedizin | Recruiting | Karlsruhe | 76133 | Germany |
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| Klinik für Kinder- und Jugendmedizin, Klinikum Dritter Orden, | Recruiting | München | 80638 | Germany |
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| Universitäts Kinderkrankenhaus und Perinatal Zentrum | Recruiting | München | 81377 | Germany |
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| Kinderklinik Dritter Orden | Recruiting | Passau | 94032 | Germany |
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| Klinik St. Hedwig | Recruiting | Regensburg | 93049 | Germany |
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| Universitätsklinikum Tübingen, Universiätsklinik für Kinder- u. Jugendmedizin | Recruiting | Tübingen | 72076 | Germany |
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| Cukurova University Hospital | Recruiting | Adana | 01330 | Turkey (Türkiye) |
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| University of Firat, Department of Pediatrics | Recruiting | Elâzığ | 23040 | Turkey (Türkiye) |
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D002534 | Hypoxia, Brain |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |