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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03357250
Other study ID # BANON I
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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