Trials / Completed
CompletedNCT03354208
Asphyxia Associated Metabolite Biomarker Investigation (AAMBI)
Verification of Biomarkers to Examine Neonatal Asphyxia Induced Hypoxic-ischemic Encephalopathy. A Prospective Multicenter Observational Study for Development of a Diagnostic Test
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 155 (actual)
- Sponsor
- Life Science Inkubator · Academic / Other
- Sex
- All
- Age
- 0 Hours – 2 Hours
- Healthy volunteers
- Accepted
Summary
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
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | blood sampling | small volume blood sampling, according to local laws, is not categorized as intervention (observational study) |
Timeline
- Start date
- 2016-10-01
- Primary completion
- 2017-12-27
- Completion
- 2017-12-27
- First posted
- 2017-11-27
- Last updated
- 2021-01-12
Locations
4 sites across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT03354208. Inclusion in this directory is not an endorsement.