Biomarkers And Neurological Outcome in Neonates (BANON)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

553 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2019-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Validation 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 and a preliminary human study.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Biomarkers And Neurological Outcome in Neonates 2

NCT04714775

Asphyxia Neonatorum

UNKNOWN

Magnetic Resonance Biomarkers in Neonatal Encephalopathy

NCT01309711

Neonatal Encephalopathy

COMPLETED

Neurotrophin Expression in Infants as a Predictor of Respiratory and Neurodevelopmental Outcomes

NCT03373539

Bronchopulmonary Dysplasia Chronic Lung Disease

COMPLETED

Brain Activity During Birth for Prediction of Newborns at Risk for Brain Injury

NCT02445417

Encephalopathy Asphyxia Newborns

COMPLETED

Incidence of Metabolic Disorders in Neonatal Convulsions

NCT06108778

Neonatal Convulsions

NOT_YET_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asphyxia Neonatorum

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Need for resuscitation after birth: For \>1 min. after birth, positive pressure respiratory support with face mask or endotracheal tube (but not only CPAP), or cardiac compressions
* 5 min APGAR-score ≤ 5.
* Perinatal hypoxia-ischemia defined as a perinatal acidosis indicated by a pH≤7.1 in arterial umbilical cord blood or early postnatal blood collected at \<30min of age
* Perinatal hypoxia-ischemia indicated by a base deficit ≥ 12mmol/l in umbilical cord blood or early postnatal blood collected at \<30min of age.

Exclusion Criteria

* Age \>1.5h
* gestational age \< 36 weeks
* birth weight \<2000g
* congenital malformation
* missing valid written informed parental consent
* unsuccessful resuscitation
* infant considered not-viable
* decision for palliative care only

Minimum Eligible Age

0 Minutes

Maximum Eligible Age

90 Minutes

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes