Biomarkers And Neurological Outcome in Neonates (BANON)

Life Science Inkubator553 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

553

Conditions

Asphyxia Neonatorum

Eligibility

Sex: ALLMin age: 0 MinutesMax age: 90 MinutesHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (11)

Abt. Neonatologie und Päd. Intensivmedizin Klinikum

Aschaffenburg, Germany

Neonatologie Universitätsklinikum

Dresden, Germany

Universitätsklinikum Essen Klinik für Kinderheilkunde I Neonatologie

Essen, Germany

Outcomes

Primary Outcomes

Validation of diagnostic algorithm

The best combinations of biomarkers from the preliminary study will be used and sensitivity and specificity as well as positive and negative likelihood ratios and their 95%-confidence limits will be calculated.

Time frame: 10 days

Data from ClinicalTrials.gov

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