Biomarkers And Neurological Outcome in Neonates 2

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04714775

Acronym

BANON2

Enrollment

500

Registered

2021-01-19

Start date

2019-02-05

Completion date

2021-12-31

Last updated

2021-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asphyxia Neonatorum

Keywords

Biomarkers, Asphyxia, Hypoxic ischemic encephalopathy

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

22 Months to 48 Months

Healthy volunteers

Inclusion criteria

* Infants previously enrolled in BANON study

Exclusion criteria

* Missing valid written informed parental consent

Design outcomes

Primary

Measure	Time frame	Description
participants with normal neuro-developmental status	up to 42 month age	all infants with normal neuro-developmental status
participants with potentially abnormal neuro-developmental status	up to 42 month age	All infants who do not fulfill outcomes 1, 3 or 4
participants with abnormal neuro-developmental status - HIE	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	up to 42 month age	Presence of adverse 2 years neuro-developmental outcome not attributable to perinatal hypoxic-ischemic brain injury

Countries

Germany, Turkey (Türkiye)

Contacts

Primary ContactRon Meyer

ron.meyer@infandx.com+49 172 266 5552

Backup ContactCarola Steins-Rang, Dr.

carola.steins-rang@infandx.com+49 22129271405

Outcome results