Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:31 AM
Study NCT ID:
NCT04714502
Status:
UNKNOWN
Last Update Posted:
2021-01-19
First Post:
2021-01-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Asphyxia Associated Metabolite Biomarker Investigation 2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001238', 'term': 'Asphyxia Neonatorum'}, {'id': 'D001237', 'term': 'Asphyxia'}, {'id': 'D020925', 'term': 'Hypoxia-Ischemia, Brain'}], 'ancestors': [{'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D002534', 'term': 'Hypoxia, Brain'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000860', 'term': 'Hypoxia'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-15', 'studyFirstSubmitDate': '2021-01-13', 'studyFirstSubmitQcDate': '2021-01-15', 'lastUpdatePostDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participants with normal neuro-developmental status', 'timeFrame': 'up to 42 month age', 'description': 'All infants with normal neuro-developmental status'}, {'measure': 'Participants with potentially abnormal neuro-developmental status', 'timeFrame': 'up to 42 month age', 'description': 'All infants who do not fulfill outcomes 1, 3 or 4'}, {'measure': 'Participants with abnormal neuro-developmental status - HIE', 'timeFrame': 'up to 42 month age', 'description': 'Presence of adverse 2 years neuro-developmental outcome likely attributable to perinatal hypoxic-ischemic brain injury'}, {'measure': 'Participants with abnormal neuro-developmental status - non-HIE', 'timeFrame': 'up to 42 month age', 'description': 'Presence of adverse 2 years neuro-developmental Outcome not attributable to perinatal hypoxic-ischemic brain injury'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['biomarkers', 'asphyxia', 'Hypoxic ischemic encephalopathy'], 'conditions': ['Birth Asphyxia']}, 'descriptionModule': {'briefSummary': 'Follow-up of participants of AAMBI1 study at age of at least 2 years. AAMBI1(ClinicalTrials.gov ID: NCT03354208): Verification 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.', 'detailedDescription': 'Follow-Up on neuro-developmental status of Study participants of AAMBI1. AAMBI1(ClinicalTrials.gov ID: NCT03354208): The aim of the study is to verify 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '48 Months', 'minimumAge': '22 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children, who had been enrolled in the AAMBI study immediately after birth because they had been suspected to be at risk for perinatal brain injury (hypoxic-ischemic encephalopathy, HIE) and/or evaluated for hypothermia therapy or because they had been enrolled in AAMBI as healthy controls (with adaptation disorder only).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants previously enrolled in the AAMBI1 study\n\nExclusion Criteria:\n\n* Missing valid written informed parental consent'}, 'identificationModule': {'nctId': 'NCT04714502', 'acronym': 'AAMBI2', 'briefTitle': 'Asphyxia Associated Metabolite Biomarker Investigation 2', 'organization': {'class': 'INDUSTRY', 'fullName': 'InfanDx AG'}, 'officialTitle': 'Verification of Biomarkers to Examine Neonatal Asphyxia-induced Hypoxic-ischemic Encephalopathy Study on Neuro-developmental Follow-up at 2 Years A Prospective Multicenter Observational Study for Development of a Diagnostic Test', 'orgStudyIdInfo': {'id': 'AAMBI2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Infants enrolled in AAMBI1'}]}, 'contactsLocationsModule': {'locations': [{'zip': '01330', 'city': 'Adana', 'country': 'Turkey (Türkiye)', 'facility': 'Turkey Cukurova University', 'geoPoint': {'lat': 36.98615, 'lon': 35.32531}}, {'zip': '23110', 'city': 'Elâzığ', 'country': 'Turkey (Türkiye)', 'facility': 'University of Firat', 'geoPoint': {'lat': 38.67431, 'lon': 39.22321}}, {'zip': '34164', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Özel Güngören Hastanesi', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '33343', 'city': 'Mersin', 'country': 'Turkey (Türkiye)', 'facility': 'Mersin University School of Medicine', 'geoPoint': {'lat': 36.81196, 'lon': 34.63886}}], 'overallOfficials': [{'name': 'Ron Meyer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'InfanDx AG'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'InfanDx AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Cukurova University', 'class': 'OTHER'}, {'name': "University Children's Hospital Tuebingen", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}