Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2026-03-03 @ 4:49 PM
Study NCT ID:
NCT02800018
Status:
COMPLETED
Last Update Posted:
2018-05-02
First Post:
2016-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation of Risk Factors and Severity of Hypoxic-ischaemic Encephalopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020925', 'term': 'Hypoxia-Ischemia, Brain'}], 'ancestors': [{'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'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012307', 'term': 'Risk Factors'}], 'ancestors': [{'id': 'D012306', 'term': 'Risk'}, {'id': 'D011336', 'term': 'Probability'}, {'id': 'D013223', 'term': 'Statistics as Topic'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D015984', 'term': 'Causality'}, {'id': 'D015981', 'term': 'Epidemiologic Factors'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-01', 'studyFirstSubmitDate': '2016-06-03', 'studyFirstSubmitQcDate': '2016-06-09', 'lastUpdatePostDateStruct': {'date': '2018-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with either antepartal or intrapartal risk factors leading to hypoxic ischaemic encephalopathy and influence of these risk factors on sarnat staging during and after hypothermia therapy', 'timeFrame': '7 days', 'description': 'The investigators evaluate the incidence of the known antepartal and intrapartal risk factors and analyze if there is a statistically significant difference of the influence of intrapartal or antepartal risk factors on the progression of the encephalopathy during and after hypothermia therapy. The investigators analyze sarnat staging on day one and three as a subject to the forementioned risk factors.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hypothermia therapy', 'perinatal asphyxia'], 'conditions': ['Hypoxic Ischaemic Encephalopathy']}, 'referencesModule': {'references': [{'pmid': '31117854', 'type': 'DERIVED', 'citation': 'Scheidegger S, Held U, Grass B, Latal B, Hagmann C, Brotschi B; National Asphyxia and Cooling Register Group. Association of perinatal risk factors with neurological outcome in neonates with hypoxic ischemic encephalopathy. J Matern Fetal Neonatal Med. 2021 Apr;34(7):1020-1027. doi: 10.1080/14767058.2019.1623196. Epub 2019 Jun 4.'}]}, 'descriptionModule': {'briefSummary': 'The first aim of this study is to analyse perinatal risk factors leading to hypoxic ischaemic encephalopathy in term and near term neonates born in Switzerland who were admitted to the neonatal and intensive care units offering hypothermia therapy.\n\nFurther, investigators would like to analyse the influence of these perinatal risk factors on the severity of encephalopathy during and after hypothermia therapy.', 'detailedDescription': 'Encephalopathy of the neonate could have different aetiologies. Perinatal asphyxia leading to hypoxia-ischaemia is frequent ,1-2 per 1000 life born neonates are affected. Hypoxic ischaemic encephalopathy is one of the most important causes for adverse neurodevelopmental outcome, cerebral palsy, epilepsy and hearing and vision deficiencies in term and near term neonates. Til now, hypothermia therapy is the only therapy reducing the risk of adverse neurodevelopmental outcome and is nowadays standard of care. In this study investigators would like to analyse perinatal risk factors causing HIE and their influence on the Sarnat Score on day 1 and 3 of life (during hypothermia therapy) and on day 4 of life (after hypothermia therapy).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '42 Weeks', 'minimumAge': '35 Weeks', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Neonates born \\>35 0/7 gestational weeks with clinical signs of hypoxic encephalopathy with Apgar Score\\<5 with 10minutes of life, mechanical ventilation with 10minutes of life, pH 7.0 or BE -16mmol/L, lactate \\>12mmol/L within 60minutes after birth, and seizures or Sarnat staging II-III or Thompson Score \\>7.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* This study includes data of neonates suffering from hypoxic-ischaemic encephalopathy born with a gestational age \\> 35 0/7 weeks, who were admitted to the neonatal and intensive care units in Switzerland between 2011-2013 and were treated with therapeutic hypothermia.\n\nExclusion Criteria:\n\n* Neonates with hypoxic-ischaemic encephalopathy, born with a gestational age \\< 35 0/7 weeks or without hypothermia treatment or syndromal diseases or with malformations were excluded.\n* Further, children without consent to research use were excluded.'}, 'identificationModule': {'nctId': 'NCT02800018', 'briefTitle': 'Correlation of Risk Factors and Severity of Hypoxic-ischaemic Encephalopathy', 'organization': {'class': 'OTHER', 'fullName': "University Children's Hospital, Zurich"}, 'officialTitle': 'Evaluation of Perinatal Risk Factors for Hypoxic-ischaemic Encephalopathy (HIE) and Their Influence on Severity of Encephalopathy During and After Hypothermia Therapy', 'orgStudyIdInfo': {'id': '2016-00242'}}, 'armsInterventionsModule': {'interventions': [{'name': 'risk factors', 'type': 'OTHER', 'description': 'investigators will analyze if certain risk factors will influence the progression of the encephalopathy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8044', 'city': 'Zurich', 'country': 'Switzerland', 'facility': "University Children's hospital Zurich", 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "University Children's Hospital, Zurich", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}