Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-29 @ 3:49 AM
Study NCT ID:
NCT01620203
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2012-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study in Preterm Infants With Intracranial Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002534', 'term': 'Hypoxia, Brain'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000860', 'term': 'Hypoxia'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-16', 'studyFirstSubmitDate': '2012-06-05', 'studyFirstSubmitQcDate': '2012-06-12', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in cerebral oxygenation', 'timeFrame': 'postnatal weeks 4 and 8', 'description': 'Comparison of the progression of cerebral oxygenation measured non-invasively by near infrared spectroscopy over time in infants with ICH and non-ICH infants.'}], 'secondaryOutcomes': [{'measure': 'Change in cerebral perfusion and function', 'timeFrame': 'post natal weeks 4 and 8', 'description': 'Comparisons of ultrasound measurements of superior vena cava flow and brain electrical activity by electroencephalography over time in infants with ICH and non-ICH infants.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Premature infants', 'Intracranial hemorrhage', 'Intraventricular hemorrhage', 'Cerebral oxygenation', 'Brain function', 'Cerebral perfusion'], 'conditions': ['Intracranial Hemorrhage', 'Intraventricular Hemorrhage', 'Cerebral Hypoxia']}, 'descriptionModule': {'briefSummary': 'Intracranial Hemorrhage (ICH) is an important morbidity affecting premature infants and can have considerable effects on neurodevelopmental outcome.\n\nThe investigators showed that preterm infants with severe ICH have decreased cerebral oxygenation several weeks after the hemorrhage. The mechanisms involved in this state of decreased cerebral oxygenation in preterm infants and the effects on cerebral function are unknown.\n\nThis longitudinal observation study will evaluate physiologic parameters to determine trends in cerebral oxygenation and function in preterm infants with ICH in comparison to infants without ICH.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Days', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Preterm infants admitted to the newborn intensive care unit at Holtz Children's Hospital of the Jackson Memorial Hospital/University of Miami Medical Center.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preterm infants born between 23 and 28 weeks of gestation\n* Diagnosed with ICH grades II or higher during the first week after birth\n* Matched control infants without ICH.\n\nExclusion Criteria:\n\n* Major congenital malformations\n* Birth asphyxia\n* Not expected to survive'}, 'identificationModule': {'nctId': 'NCT01620203', 'briefTitle': 'Observational Study in Preterm Infants With Intracranial Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Observational Study in Preterm Infants With and Without Intracranial Hemorrhage: Longitudinal Assessment of Cerebral Oxygenation, Perfusion and Function', 'orgStudyIdInfo': {'id': '20120065'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control', 'description': 'Matched group of control infants without diagnosis of intracranial hemorrhage', 'interventionNames': ['Other: No intervention/treatment is given']}, {'label': 'Intracranial Hemorrhage', 'description': 'Group of preterm infant with diagnosis of intracranial hemorrhage.', 'interventionNames': ['Other: No intervention/treatment is given']}], 'interventions': [{'name': 'No intervention/treatment is given', 'type': 'OTHER', 'armGroupLabels': ['Control', 'Intracranial Hemorrhage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': "Holtz Children's Hospital, Jackson Memorial Hospital/University of Miami Medical Center", 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Nelson Claure, M.Sc.,Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}, {'name': 'Eduardo Bancalari, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}, {'name': 'Deepak Jain, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}, {'name': 'Sethuraman Swaminathan, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nelson Claure', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Research Associate Professor of Pediatrics', 'investigatorFullName': 'Nelson Claure', 'investigatorAffiliation': 'University of Miami'}}}}