We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 27 for:    banon
Previous Study | Return to List | Next Study

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.
 
ClinicalTrials.gov Identifier: NCT03357250
Recruitment Status : Completed
First Posted : November 29, 2017
Last Update Posted : January 12, 2021
Sponsor:
Collaborator:
University Hospital Tuebingen
Information provided by (Responsible Party):
Life Science Inkubator

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 553 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
Actual Primary Completion Date : June 2019
Actual Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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:   0 Minutes 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
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT03357250


Locations
Layout table for location information
Germany
Abt. Neonatologie und Päd. Intensivmedizin Klinikum
Aschaffenburg, Germany, 63739
Neonatologie Universitätsklinikum
Dresden, Germany, 01307
Universitätsklinikum Essen Klinik für Kinderheilkunde I Neonatologie
Essen, Germany, 45147
Marienkrankenhaus im Wilhelmstift
Hamburg, Germany, 22087
Universitätsklinikum Heidelberg Neonatologie
Heidelberg, Germany, 69120
Klinik für Kinder- und Jugendmedizin
Karlsruhe, Germany, 76133
Klinik für Kinder- und Jugendmedizin, Klinikum Dritter Orden
München, Germany, 80638
Haunersches Kinderspital am Perinatalzentrum Grosshadern
München, Germany, 81377
Kinderklinik Dritter Orden
Passau, Germany, 94032
Klinik St. Hedwig Neonatologie
Regensburg, Germany, 93049
Klinik für Kinder und Jugendmedizin
Tübingen, Germany, 72070
Sponsors and Collaborators
Life Science Inkubator
University Hospital Tuebingen
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Life Science Inkubator
ClinicalTrials.gov Identifier: NCT03357250    
Other Study ID Numbers: BANON I
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: January 12, 2021
Last Verified: November 2020
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:
biomarkers
Additional relevant MeSH terms:
Layout table for MeSH terms
Asphyxia Neonatorum
Asphyxia
Death
 Pathologic Processes
Wounds and Injuries
Infant, Newborn, Diseases