An observational study in Asphyxia Neonatorum, sponsored by Life Science Inkubator. Completed at 4 sites in Turkey. Open to participants aged 0 Hours to 2 Hours, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-12.
Sponsored by Life Science Inkubator · Observational
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.
106 studies on the registry are indexed under Asphyxia Neonatorum; 19 are open to participants now.
This study's enrollment of 155 is below the median of 200 across 27 observational studies indexed under Asphyxia Neonatorum.
Browse Asphyxia Neonatorum studies →Life Science Inkubator is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Infants at risk for perinatal hypoxic-ischemic brain injury
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
patients with hypoxic-ischemic encephalopathy (HIE) receiving hypothermia therapy
Other: blood sampling
patients with suspected HIE, non-confirmed
Other: blood sampling
healthy, retrospectively classified as such
Other: blood sampling
small volume blood sampling, according to local laws, is not categorized as intervention (observational study)
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.
Time frame: 14 days for clinical diagnosis
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2016 to primary completion in Dec 2017, 14 months.
Of 16 observational studies under Asphyxia Neonatorum, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 47. This study's 14 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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