Asphyxia Associated Metabolite Biomarker Investigation (AAMBI)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Verification of Biomarkers to Examine Neonatal Asphyxia Induced Hypoxic-ischemic Encephalopathy. A Prospective Multicenter Observational Study for Development of a Diagnostic Test

Conditions
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Asphyxia Neonatorum

Intervention / Treatment
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* Other: blood sampling


Participation Criteria
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Eligibility Criteria
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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 Perinatal hypoxia-ischemia (defined as a perinatal acidosis indicated by a pH≤7.10 or a base excess ≤-12mmol/l in umbilical cord blood or early postnatal blood collected at <90min of age (outborn patients) 5min APGAR-score ≤ 5 Need for resuscitation after birth for >1 min. after birth, positive pressure respiratory support with face mask or endotracheal tube, or cardiac compressions Group 3: UApH >7,25, and adaptation disorder of the newborn and need of postnatal clinical surveillance Exclusion Criteria: gestational age < 36 weeks age at time of screening >2,5h congenital malformation missing or invalid informed parental consent unsuccessful resuscitation infant considered not-viable decision for palliative care only

Ages Eligible for Study
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Minimum Age: 0 Hours
Maximum Age: 2 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>patients with hypoxic-ischemic encephalopathy (HIE) receiving hypothermia therapy | Other: blood sampling<br>* small volume blood sampling, according to local laws, is not categorized as intervention (observational study)<br>|
| Group 2<br>patients with suspected HIE, non-confirmed | Other: blood sampling<br>* small volume blood sampling, according to local laws, is not categorized as intervention (observational study)<br>|
| Group 3<br>healthy, retrospectively classified as such | Other: blood sampling<br>* small volume blood sampling, according to local laws, is not categorized as intervention (observational study)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biomarkers