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| Name | Class |
|---|---|
| Cukurova University | OTHER |
| University Children's Hospital Tuebingen | OTHER |
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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.
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 |
|---|---|---|---|
| Group 1 | patients with hypoxic-ischemic encephalopathy (HIE) receiving hypothermia therapy |
| |
| Group 2 | patients with suspected HIE, non-confirmed |
| |
| Group 3 | healthy, retrospectively classified as such |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood sampling | Other | small volume blood sampling, according to local laws, is not categorized as intervention (observational study) |
|
| Measure | Description | Time Frame |
|---|---|---|
| abnormal short-term outcome (NE) | All patients are classified as abnormal short-term outcome (neonatal encephalopathy, NE) or normal short term outcome (no encephalopathy) by using clinical data, particularly Thompson score. For Group 1 and group 2 patients outcome classification will be additionally confirmed by using cranial ultrasound or MRI (including severe ischemia based on DWI or thalamic or cerebellar bleeding or arterial infarction or IVH>2° according to Papile, thalamic ischemia or severe cerebral edema) or seizure activity or burst suppression on aEEG or persistingly abnormal aEEG background pattern after complete rewarming. Bloodplasma samples will be analysed by a metabolomics approach using the p180-kit (Biocrates, Innsbruck, Austria). Metabolite concentrations or combinations thereof will be compared to the outcome described above in order to identify the most suitable metabolites to be used for early detection of NE in newborn infants. | 14 days for clinical diagnosis |
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Inclusion Criteria:
Group 1: inclusion criteria fulfilled for hypothermia treatment Group 2: Infants with suspected perinatal brain injury due to one of the followings
Exclusion Criteria:
gestational age < 36 weeks
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Infants at risk for perinatal hypoxic-ischemic brain injury
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| Name | Affiliation | Role |
|---|---|---|
| Ron Meyer | Life Science Inkubator Betriebs GmbH & Co. KG | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cukurova University | Adana | 01330 | Turkey (Türkiye) | |||
| University of Firat |
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| ID | Term |
|---|---|
| D001238 | Asphyxia Neonatorum |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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blood plasma
| Elâzığ |
| Turkey (Türkiye) |
| Özel Güngören Hastanesi | Istanbul | 34164 | Turkey (Türkiye) |
| Mersin University School of Medicine | Mersin | 33343 | Turkey (Türkiye) |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |