Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-01-04 @ 4:51 PM
Study NCT ID:
NCT01866358
Status:
COMPLETED
Last Update Posted:
2018-06-15
First Post:
2013-05-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraosseous Infusion for Neonatal Asphyxiated Resuscitation
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017148', 'term': 'Infusions, Intraosseous'}], 'ancestors': [{'id': 'D007263', 'term': 'Infusions, Parenteral'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-13', 'studyFirstSubmitDate': '2013-05-21', 'studyFirstSubmitQcDate': '2013-05-28', 'lastUpdatePostDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Success rate of puncture', 'timeFrame': '24 hours'}], 'primaryOutcomes': [{'measure': 'success rate of resuscitation', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': 'Injury of brain and heart', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Asphyxia Neonatorum']}, 'descriptionModule': {'briefSummary': 'Intraosseous infusion is better than umbilical vein infusion for neonatal asphyxiated resuscitation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '42 Weeks', 'minimumAge': '28 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* newborns who need resucitation\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01866358', 'briefTitle': 'Intraosseous Infusion for Neonatal Asphyxiated Resuscitation', 'organization': {'class': 'OTHER', 'fullName': 'Third Military Medical University'}, 'officialTitle': 'Intraosseous Infusion for Neonatal Asphyxiated Resuscitation', 'orgStudyIdInfo': {'id': 'Wanglan'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Umbilical vein infusion', 'description': 'using umbilical vein infusion for resucitation', 'interventionNames': ['Procedure: Umbilical vein infusion']}, {'type': 'EXPERIMENTAL', 'label': 'Intraosseous infusion', 'description': 'using intraosseous infusion for resucitation', 'interventionNames': ['Procedure: Intraosseous infusion']}], 'interventions': [{'name': 'Intraosseous infusion', 'type': 'PROCEDURE', 'description': 'Using intraosseous infusion for resustation in this group', 'armGroupLabels': ['Intraosseous infusion']}, {'name': 'Umbilical vein infusion', 'type': 'PROCEDURE', 'description': 'Using umbilical vein infusion for resustation in this group', 'armGroupLabels': ['Umbilical vein infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400042', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': 'Pediatrics of Daping Hospital', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'overallOfficials': [{'name': 'Shi Yuan, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Professor, Chief of Pediatric Department'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Third Military Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'director，head nurse of pediatric department ，principal investigator ，clinical professor', 'investigatorFullName': 'Lixue', 'investigatorAffiliation': 'Third Military Medical University'}}}}