COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Biomarkers And Neurological Outcome in Neonates (BANON)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03357250
Recruitment Status : Unknown
Verified November 2017 by Life Science Inkubator.
Recruitment status was:  Recruiting
First Posted : November 29, 2017
Last Update Posted : November 29, 2017
University Hospital Tuebingen
Information provided by (Responsible Party):
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.

Condition or disease
Asphyxia Neonatorum

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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 14 Days
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
Actual Study Start Date : September 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Validation of diagnostic algorithm [ Time Frame: 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.

Biospecimen Retention:   Samples Without DNA
blood plasma

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   up to 90 Minutes   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Infants at risk for perinatal hypoxic-ischemic brain injury

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03357250

Layout table for location contacts
Contact: Ron Meyer +49 228-227790-286
Contact: Axel Franz, Prof.

Layout table for location information
Abt. Neonatologie und Päd. Intensivmedizin Klinikum Recruiting
Aschaffenburg, Germany, 63739
Contact: Christian Wieg, Dr.   
Neonatologie Universitätsklinikum Recruiting
Dresden, Germany, 01307
Contact: Mario Rüdiger, Prof   
Universitätsklinikum Essen Klinik für Kinderheilkunde I Neonatologie Recruiting
Essen, Germany, 45147
Contact: Ursula Felderhoff-Müser, Prof   
Marienkrankenhaus im Wilhelmstift Recruiting
Hamburg, Germany, 22087
Contact: Lutz Koch, Prof   
Universitätsklinikum Heidelberg Neonatologie Recruiting
Heidelberg, Germany, 69120
Contact: Johannes Pöschl, Prof   
Klinik für Kinder- und Jugendmedizin Recruiting
Karlsruhe, Germany, 76133
Contact: Joachim Kühr, Prof   
Klinik für Kinder- und Jugendmedizin, Klinikum Dritter Orden Recruiting
München, Germany, 80638
Contact: Jochen Peters, Prof   
Haunersches Kinderspital am Perinatalzentrum Grosshadern Recruiting
München, Germany, 81377
Contact: Andreas Flemmer, Prof   
Kinderklinik Dritter Orden Recruiting
Passau, Germany, 94032
Contact: Matthias Keller, Prof   
Klinik St. Hedwig Neonatologie Recruiting
Regensburg, Germany, 93049
Contact: Hugo Segerer, Prof   
Klinik für Kinder und Jugendmedizin Recruiting
Tübingen, Germany, 72070
Contact: Axel Franz, Prof.   
Contact: Andreas Eichhorn   
Sponsors and Collaborators
Life Science Inkubator
University Hospital Tuebingen
Additional Information:

Layout table for additonal information
Responsible Party: Life Science Inkubator Identifier: NCT03357250    
Other Study ID Numbers: BANON I
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Life Science Inkubator:
Additional relevant MeSH terms:
Layout table for MeSH terms
Asphyxia Neonatorum
Pathologic Processes
Wounds and Injuries
Infant, Newborn, Diseases