Clinical trial NCT03357250: Biomarkers And Neurological Outcome in Neonates (BANON)
Official title: Validation of Biomarkers of Adverse Neurologic Outcome in Newborns Who Required Resuscitation or Are Suspected to be at Risk for Perinatal Brain Injury and Long-term Adverse Neurological Outcome A Prospective Multicenter Observational Study for Development of a Diagnostic Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asphyxia Neonatorum
Keywords: biomarkers
Lead sponsor: Life Science Inkubator
Sponsor class: OTHER
Collaborators: name: University Hospital Tuebingen
First posted: 2017-11-29
Enrollment: 553
Sex: ALL
Minimum age (years): 0
Maximum age (years): 90
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infants at risk for perinatal hypoxic-ischemic brain injury

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.

Eligibility criteria: 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

Primary outcomes:
measure: Validation of diagnostic algorithm
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Aschaffenburg
country: Germany
facility: Abt. Neonatologie und Päd. Intensivmedizin Klinikum
city: Dresden
country: Germany
facility: Neonatologie Universitätsklinikum
city: Essen
country: Germany
facility: Universitätsklinikum Essen Klinik für Kinderheilkunde I Neonatologie
city: Hamburg
country: Germany
facility: Marienkrankenhaus im Wilhelmstift
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg Neonatologie
city: Karlsruhe
country: Germany
facility: Klinik für Kinder- und Jugendmedizin
city: München
country: Germany
facility: Klinik für Kinder- und Jugendmedizin, Klinikum Dritter Orden
city: München
country: Germany
facility: Haunersches Kinderspital am Perinatalzentrum Grosshadern
city: Passau
country: Germany
facility: Kinderklinik Dritter Orden
city: Regensburg
country: Germany
facility: Klinik St. Hedwig Neonatologie
city: Tübingen
country: Germany
facility: Klinik für Kinder und Jugendmedizin
Study officials:
References: