Biomarkers And Neurological Outcome in Neonates (BANON)

Completed

• Conditions: Asphyxia Neonatorum

• Registration Number: NCT03357250
• Lead Sponsor: Life Science Inkubator

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2016-09
• Study First Submitted: 2017-11-24
• Study First Submitted QC: 2017-11-24
• Study First Posted: 2017-11-29
• Primary Completion: 2019-06
• Study Completion: 2019-06
• Status Verified: 2020-11
• Last Update Submitted: 2021-01-09
• Last Update Posted: 2021-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 553

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Validation of diagnostic algorithm	10 days	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.

Trial Locations

Locations (11)

Abt. Neonatologie und Päd. Intensivmedizin Klinikum; 🇩🇪 Aschaffenburg, Germany

Haunersches Kinderspital am Perinatalzentrum Grosshadern; 🇩🇪 München, Germany

Neonatologie Universitätsklinikum; 🇩🇪 Dresden, Germany

Universitätsklinikum Essen Klinik für Kinderheilkunde I Neonatologie; 🇩🇪 Essen, Germany

Marienkrankenhaus im Wilhelmstift; 🇩🇪 Hamburg, Germany

Klinik für Kinder- und Jugendmedizin; 🇩🇪 Karlsruhe, Germany

Klinik St. Hedwig Neonatologie; 🇩🇪 Regensburg, Germany

Universitätsklinikum Heidelberg Neonatologie; 🇩🇪 Heidelberg, Germany

Klinik für Kinder- und Jugendmedizin, Klinikum Dritter Orden; 🇩🇪 München, Germany

Kinderklinik Dritter Orden; 🇩🇪 Passau, Germany

Klinik für Kinder und Jugendmedizin; 🇩🇪 Tübingen, Germany