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| Name | Class |
|---|---|
| Cukurova University | OTHER |
| University Children's Hospital Tuebingen | OTHER |
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Follow-up of participants of AAMBI1 study at age of at least 2 years. AAMBI1(ClinicalTrials.gov ID: NCT03354208): Verification of biomarkers 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.
Follow-Up on neuro-developmental status of Study participants of AAMBI1. AAMBI1(ClinicalTrials.gov ID: NCT03354208): The aim of the study is to verify 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infants enrolled in AAMBI1 |
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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 AAMBI 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 or because they had been enrolled in AAMBI as healthy controls (with adaptation disorder only).
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| Name | Affiliation | Role |
|---|---|---|
| Ron Meyer | InfanDx AG | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Turkey Cukurova University | Adana | 01330 | Turkey (Türkiye) | |||
| University of Firat |
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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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| Elâzığ |
| 23110 |
| Turkey (Türkiye) |
| Özel Güngören Hastanesi | Istanbul | 34164 | Turkey (Türkiye) |
| Mersin University School of Medicine | Mersin | 33343 | Turkey (Türkiye) |
| 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 |