Status:
COMPLETED
Biomarkers And Neurological Outcome in Neonates (BANON)
Lead Sponsor:
Life Science Inkubator
Collaborating Sponsors:
University Hospital Tuebingen
Conditions:
Asphyxia Neonatorum
Eligibility:
All Genders
Up to 90 years
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 prelimi...
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 abnorma...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2019
Estimated Enrollment :
553 Patients enrolled
Trial Details
Trial ID
NCT03357250
Start Date
September 1 2016
End Date
June 1 2019
Last Update
January 12 2021
Active Locations (11)
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1
Abt. Neonatologie und Päd. Intensivmedizin Klinikum
Aschaffenburg, Germany, 63739
2
Neonatologie Universitätsklinikum
Dresden, Germany, 01307
3
Universitätsklinikum Essen Klinik für Kinderheilkunde I Neonatologie
Essen, Germany, 45147
4
Marienkrankenhaus im Wilhelmstift
Hamburg, Germany, 22087