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
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 |
Verified date | November 2020 |
Source | Life Science Inkubator |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Life Science Inkubator | University Hospital Tuebingen |
Germany,
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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