An observational study in Asphyxia Neonatorum, sponsored by InfanDx AG. Status unknown at 13 sites in 2 countries. Open to participants aged 22 Months to 48 Months. Per ClinicalTrials.gov, last updated 2021-01-20.
Sponsored by InfanDx AG · Observational
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.
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.
106 studies on the registry are indexed under Asphyxia Neonatorum; 23 are open to participants now.
This study's planned enrollment of 500 is above the median of 183 across 20 observational studies indexed under Asphyxia Neonatorum.
Browse Asphyxia Neonatorum studies →InfanDx AG is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children, who had been enrolled in the BANON study immediately after birth because they had been suspected to be at risk for perinatal brain injury (hypoxic-ischemic encephalopathy, HIE) and/or evaluated for hypothermia therapy.
Exclusion Criteria:
participants with normal neuro-developmental status
all infants with normal neuro-developmental status
Time frame: up to 42 month age
participants with potentially abnormal neuro-developmental status
All infants who do not fulfill outcomes 1, 3 or 4
Time frame: up to 42 month age
participants with abnormal neuro-developmental status - HIE
Presence of adverse 2 years neuro-developmental outcome likely attributable to perinatal hypoxic-ischemic brain injury
Time frame: up to 42 month age
participants with abnormal neuro-developmental status - non-HIE
Presence of adverse 2 years neuro-developmental outcome not attributable to perinatal hypoxic-ischemic brain injury
Time frame: up to 42 month age
This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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InfanDx AG