Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2026-04-11 @ 8:49 PM
Study NCT ID:
NCT03357250
Status:
COMPLETED
Last Update Posted:
2021-01-12
First Post:
2017-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers And Neurological Outcome in Neonates (BANON)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001238', 'term': 'Asphyxia Neonatorum'}], 'ancestors': [{'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 553}, 'targetDuration': '14 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2019-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-09', 'studyFirstSubmitDate': '2017-11-24', 'studyFirstSubmitQcDate': '2017-11-24', 'lastUpdatePostDateStruct': {'date': '2021-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validation of diagnostic algorithm', 'timeFrame': '10 days', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['biomarkers'], 'conditions': ['Asphyxia Neonatorum']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '90 Minutes', 'minimumAge': '0 Minutes', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Infants at risk for perinatal hypoxic-ischemic brain injury', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* 5 min APGAR-score ≤ 5.\n* 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\n* Perinatal hypoxia-ischemia indicated by a base deficit ≥ 12mmol/l in umbilical cord blood or early postnatal blood collected at \\<30min of age.\n\nExclusion Criteria:\n\n* Age \\>1.5h\n* gestational age \\< 36 weeks\n* birth weight \\<2000g\n* congenital malformation\n* missing valid written informed parental consent\n* unsuccessful resuscitation\n* infant considered not-viable\n* decision for palliative care only'}, 'identificationModule': {'nctId': 'NCT03357250', 'briefTitle': 'Biomarkers And Neurological Outcome in Neonates (BANON)', 'organization': {'class': 'OTHER', 'fullName': 'Life Science Inkubator'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'BANON I'}}, 'contactsLocationsModule': {'locations': [{'zip': '63739', 'city': 'Aschaffenburg', 'country': 'Germany', 'facility': 'Abt. Neonatologie und Päd. Intensivmedizin Klinikum', 'geoPoint': {'lat': 49.97704, 'lon': 9.15214}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Neonatologie Universitätsklinikum', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '45147', 'city': 'Essen', 'country': 'Germany', 'facility': 'Universitätsklinikum Essen Klinik für Kinderheilkunde I Neonatologie', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '22087', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Marienkrankenhaus im Wilhelmstift', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Universitätsklinikum Heidelberg Neonatologie', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '76133', 'city': 'Karlsruhe', 'country': 'Germany', 'facility': 'Klinik für Kinder- und Jugendmedizin', 'geoPoint': {'lat': 49.00937, 'lon': 8.40444}}, {'zip': '80638', 'city': 'München', 'country': 'Germany', 'facility': 'Klinik für Kinder- und Jugendmedizin, Klinikum Dritter Orden', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '81377', 'city': 'München', 'country': 'Germany', 'facility': 'Haunersches Kinderspital am Perinatalzentrum Grosshadern', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '94032', 'city': 'Passau', 'country': 'Germany', 'facility': 'Kinderklinik Dritter Orden', 'geoPoint': {'lat': 48.5665, 'lon': 13.43122}}, {'zip': '93049', 'city': 'Regensburg', 'country': 'Germany', 'facility': 'Klinik St. Hedwig Neonatologie', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'zip': '72070', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'Klinik für Kinder und Jugendmedizin', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Life Science Inkubator', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital Tuebingen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}