Biomarkers And Neurological Outcome in Neonates (BANON)

Asphyxia Neonatorum Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03357250
• Other study ID #: BANON I
• Status: Completed
• Start date: September 2016
• Est. completion date: June 2019

Study information

• Verified date: November 2020
• Source: Life Science Inkubator
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 553
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 90 Minutes

Eligibility

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

Related Conditions & MeSH terms

• Asphyxia
• Asphyxia Neonatorum

Locations

Country	Name	City	State
Germany	Abt. Neonatologie und Päd. Intensivmedizin Klinikum	Aschaffenburg
Germany	Neonatologie Universitätsklinikum	Dresden
Germany	Universitätsklinikum Essen Klinik für Kinderheilkunde I Neonatologie	Essen
Germany	Marienkrankenhaus im Wilhelmstift	Hamburg
Germany	Universitätsklinikum Heidelberg Neonatologie	Heidelberg
Germany	Klinik für Kinder- und Jugendmedizin	Karlsruhe
Germany	Haunersches Kinderspital am Perinatalzentrum Grosshadern	München
Germany	Klinik für Kinder- und Jugendmedizin, Klinikum Dritter Orden	München
Germany	Kinderklinik Dritter Orden	Passau
Germany	Klinik St. Hedwig Neonatologie	Regensburg
Germany	Klinik für Kinder und Jugendmedizin	Tübingen

Sponsors (2)

Lead Sponsor	Collaborator
Life Science Inkubator	University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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