Biomarkers And Neurological Outcome in Neonates (BANON)

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

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.

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 553

Contacts and Locations

Study Locations

• Germany
  • Aschaffenburg, Germany, 63739
    • Abt. Neonatologie und Päd. Intensivmedizin Klinikum
  • Dresden, Germany, 01307
    • Neonatologie Universitätsklinikum
  • Essen, Germany, 45147
    • Universitätsklinikum Essen Klinik für Kinderheilkunde I Neonatologie
  • Hamburg, Germany, 22087
    • Marienkrankenhaus im Wilhelmstift
  • Heidelberg, Germany, 69120
    • Universitätsklinikum Heidelberg Neonatologie
  • Karlsruhe, Germany, 76133
    • Klinik für Kinder- und Jugendmedizin
  • München, Germany, 80638
    • Klinik für Kinder- und Jugendmedizin, Klinikum Dritter Orden
  • München, Germany, 81377
    • Haunersches Kinderspital am Perinatalzentrum Grosshadern
  • Passau, Germany, 94032
    • Kinderklinik Dritter Orden
  • Regensburg, Germany, 93049
    • Klinik St. Hedwig Neonatologie
  • Tübingen, Germany, 72070
    • Klinik für Kinder und Jugendmedizin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 1 hour (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Infants at risk for perinatal hypoxic-ischemic brain injury

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 days

Collaborators and Investigators

• Sponsor: Life Science Inkubator
• Collaborators: University Hospital Tuebingen

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2016
• Primary Completion (ACTUAL): June 1, 2019
• Study Completion (ACTUAL): June 1, 2019

Study Registration Dates

• First Submitted: November 24, 2017
• First Submitted That Met QC Criteria: November 24, 2017
• First Posted (ACTUAL): November 29, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 12, 2021
• Last Update Submitted That Met QC Criteria: January 9, 2021
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: biomarkers
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Infant, Newborn, Diseases; Death; Asphyxia; Asphyxia Neonatorum
• Other Study ID Numbers: BANON I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No