NCT03357250

Biomarkers And Neurological Outcome in Neonates (BANON)

Validation of Biomarkers of Adverse Neurologic Outcome in Newborns Who Required Resuscitation or Are Suspected to be at Risk for Perinatal Brain Injury and Long-term Adverse Neurological Outcome A Prospective Multicenter Observational Study for Development of a Diagnostic Test

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 553 (actual)
• Sponsor: Life Science Inkubator · Academic / Other
• Sex: All
• Age: 0 Minutes – 90 Minutes
• Healthy volunteers: Accepted

Summary

Validation 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 and a preliminary human study.

Detailed description

The aim of the study is to validate 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, and where the combination of laboratory parameters is derived from a preliminary study performed in Turkey (AAMBI) using a metabolomics approach.

Conditions

• Asphyxia Neonatorum

Timeline

• Start date: 2016-09-01
• Primary completion: 2019-06-01
• Completion: 2019-06-01
• First posted: 2017-11-29
• Last updated: 2021-01-12

Locations

11 sites across 1 country: Germany