Clinical trial NCT04714775: Biomarkers And Neurological Outcome in Neonates 2
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asphyxia Neonatorum
Keywords: Biomarkers
Asphyxia
Hypoxic ischemic encephalopathy
Lead sponsor: InfanDx AG
Sponsor class: INDUSTRY
Collaborators: name: University Hospital Tuebingen
First posted: 2021-01-19
Enrollment: 500
Sex: ALL
Minimum age (years): 22
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: Inclusion Criteria:

* Infants previously enrolled in BANON study

Exclusion Criteria:

* Missing valid written informed parental consent

Primary outcomes:
measure: participants with normal neuro-developmental status
timeFrame: up to 42 month age
measure: participants with potentially abnormal neuro-developmental status
timeFrame: up to 42 month age
measure: participants with abnormal neuro-developmental status - HIE
timeFrame: up to 42 month age
measure: participants with abnormal neuro-developmental status - non-HIE
timeFrame: up to 42 month age
Secondary outcomes:
Other outcomes:
Locations:
city: Aschaffenburg
country: Germany
facility: Städtisches Krankenhaus Aschaffenburg
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus, Neonatologie
city: Essen
country: Germany
facility: Uniklinik Essen
city: Hamburg
country: Germany
facility: Marienkrankenhaus
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Karlsruhe
country: Germany
facility: Städtisches Klinikum Karlsruhe, Klinik für Kinder- und Jugendmedizin
city: München
country: Germany
facility: Klinik für Kinder- und Jugendmedizin, Klinikum Dritter Orden,
city: München
country: Germany
facility: Universitäts Kinderkrankenhaus und Perinatal Zentrum
city: Passau
country: Germany
facility: Kinderklinik Dritter Orden
city: Regensburg
country: Germany
facility: Klinik St. Hedwig
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen, Universiätsklinik für Kinder- u. Jugendmedizin
city: Adana
country: Turkey
facility: Cukurova University Hospital
city: Elazığ
country: Turkey
facility: University of Firat, Department of Pediatrics
Study officials:
affiliation: InfanDx AG
name: Ron Meyer
role: STUDY_DIRECTOR
References: