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Biomarkers And Neurological Outcome in Neonates 2 (BANON2)

I

InfanDx

Status

Unknown

Conditions

Asphyxia Neonatorum

Study type

Observational

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 estimated patients

Sex

All

Ages

22 to 48 months old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Infants previously enrolled in BANON study

Exclusion criteria

  • Missing valid written informed parental consent

Trial contacts and locations

13

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Central trial contact

Carola Steins-Rang, Dr.; Ron Meyer

Data sourced from clinicaltrials.gov

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