Verification of Biomarkers to Examine Neonatal Asphyxia-induced Hypoxic-ischemic Encephalopathy 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
- Birth Asphyxia
- Sponsor
- InfanDx AG
- Enrollment
- 144
- Locations
- 4
- Primary Endpoint
- Participants with abnormal neuro-developmental status - non-HIE
- Last Updated
- 5 years ago
Overview
Brief Summary
Follow-up of participants of AAMBI1 study at age of at least 2 years. AAMBI1(ClinicalTrials.gov ID: NCT03354208): 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
Follow-Up on neuro-developmental status of Study participants of AAMBI1. AAMBI1(ClinicalTrials.gov ID: NCT03354208): 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Infants previously enrolled in the AAMBI1 study
Exclusion Criteria
- •Missing valid written informed parental consent
Outcomes
Primary Outcomes
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
Participants with normal neuro-developmental status
Time Frame: up to 42 month age
All infants with normal neuro-developmental status
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 potentially abnormal neuro-developmental status
Time Frame: up to 42 month age
All infants who do not fulfill outcomes 1, 3 or 4