Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2026-02-28 @ 12:03 AM
Study NCT ID:
NCT02822027
Status:
UNKNOWN
Last Update Posted:
2022-10-14
First Post:
2016-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravenous Immunoglobin Transfusion in Preterm Infants With Encephalopathy of Prematurity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-13', 'studyFirstSubmitDate': '2016-06-24', 'studyFirstSubmitQcDate': '2016-06-29', 'lastUpdatePostDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'structural changes of brain injury', 'timeFrame': '100-days', 'description': 'MRI/ultrasound will be used to assess the structural severities of brain injury.'}, {'measure': 'functional changes of brain injury', 'timeFrame': '100-days', 'description': 'Bayley score will be used to assess the functional severities of brain injury.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Preterm Infants']}, 'descriptionModule': {'briefSummary': 'Infection and inflammation is related to increased encephalopathy of prematurities.', 'detailedDescription': 'Animal studies have verified intravenous immunoglobin can reduce brain injury. However, no studies in preterm infants were reported.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Hours', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* preterm infants with encephalopathy\n\nExclusion Criteria:\n\n* refuse the participate in the trial'}, 'identificationModule': {'nctId': 'NCT02822027', 'briefTitle': 'Intravenous Immunoglobin Transfusion in Preterm Infants With Encephalopathy of Prematurity', 'organization': {'class': 'OTHER', 'fullName': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University'}, 'officialTitle': 'Intravenous Immunoglobin Transfusion in Preterm Infants With Encephalopathy of Prematurity', 'orgStudyIdInfo': {'id': 'IVIG for encephalopathy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'human gamma globulin', 'description': 'human gamma globulin for infants with encephalopathy of prematurities', 'interventionNames': ['Drug: human gamma globulin', 'Drug: non-human gamma globulin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'non-human gamma globulin', 'description': 'non-human gamma globulin for infants with encephalopathy of prematurities', 'interventionNames': ['Drug: human gamma globulin', 'Drug: non-human gamma globulin']}], 'interventions': [{'name': 'human gamma globulin', 'type': 'DRUG', 'description': 'human gamma globulin for preterm infants with encephalopathy of prematurities', 'armGroupLabels': ['human gamma globulin', 'non-human gamma globulin']}, {'name': 'non-human gamma globulin', 'type': 'DRUG', 'description': 'Non-human gamma globulin for preterm infants with encephalopathy of prematurities', 'armGroupLabels': ['human gamma globulin', 'non-human gamma globulin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400042', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wu Fang, MD', 'role': 'CONTACT', 'email': '476679422@qq.com', 'phone': '8613883559467'}], 'facility': 'Department of Pediatrics,Daping Hospital', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Wu Fang, MD', 'role': 'CONTACT', 'email': '476679422@qq.com', 'phone': '8613883559467'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Fang Wu', 'investigatorAffiliation': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University'}}}}