Validation of Biomarkers of Adverse Neurologic Outcome in Newborns at Risk for Perinatal Brain Injury - Study on Neuro-developmental Follow-up at 2 Years A Prospective Multicenter Observational Study for Development of a Diagnostic Test
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Asphyxia Neonatorum
- Sponsor
- InfanDx AG
- Enrollment
- 500
- Locations
- 13
- Primary Endpoint
- participants with normal neuro-developmental status
- Last Updated
- 5 years ago
Overview
Brief Summary
Follow-up of participants of BANON1 study at age of at least 2 years. BANON1 (ClinicalTrials.gov ID: NCT03357250): Validation of biomarkers based on 24 months neuro-developmental outcome data 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
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Infants previously enrolled in BANON study
Exclusion Criteria
- •Missing valid written informed parental consent
Outcomes
Primary Outcomes
participants with normal neuro-developmental status
Time Frame: up to 42 month age
all infants with normal neuro-developmental status
participants with potentially abnormal neuro-developmental status
Time Frame: up to 42 month age
All infants who do not fulfill outcomes 1, 3 or 4
participants with abnormal neuro-developmental status - HIE
Time Frame: 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
Time Frame: up to 42 month age
Presence of adverse 2 years neuro-developmental outcome not attributable to perinatal hypoxic-ischemic brain injury