Biomarkers And Neurological Outcome in Neonates 2

Follow-Up on neuro-developmental status of Study participants of BANON1. BANON1 (ClinicalTrials.gov ID: NCT03357250): 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.

Primary outcomes

• participants with normal neuro-developmental status [up to 42 month age]: all infants with normal neuro-developmental status
• participants with potentially abnormal neuro-developmental status [up to 42 month age]: All infants who do not fulfill outcomes 1, 3 or 4
• participants with abnormal neuro-developmental status - HIE [up to 42 month age]: Presence of adverse 2 years neuro-developmental outcome likely attributable to perinatal hypoxic-ischemic brain injury
• participants with abnormal neuro-developmental status - non-HIE [up to 42 month age]: Presence of adverse 2 years neuro-developmental outcome not attributable to perinatal hypoxic-ischemic brain injury

Sex: All, ages: 22 Months to 48 Months

Inclusion Criteria:

* Infants previously enrolled in BANON study

Exclusion Criteria:

* Missing valid written informed parental consent

• Ron Meyer, Study director, InfanDx AG