Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-26 @ 5:24 AM
Study NCT ID:
NCT03576560
Status:
COMPLETED
Last Update Posted:
2025-06-03
First Post:
2018-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Selective Use of Antibiotics in Neonates Born to Mothers With Suspected Chorioamnionitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002821', 'term': 'Chorioamnionitis'}], 'ancestors': [{'id': 'D005315', 'term': 'Fetal Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005322', 'term': 'Fetal Membranes, Premature Rupture'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D010922', 'term': 'Placenta Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 768}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-28', 'studyFirstSubmitDate': '2018-06-26', 'studyFirstSubmitQcDate': '2018-06-26', 'lastUpdatePostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Infants born to mother with chorioamnionitis/intrapartum fever as assessed by chart review.', 'timeFrame': 'Infants born from July, 2012 to December 31, 2018.', 'description': 'The retrospective chart review would analyze the total number of infants born to mothers with chorioamnionitis/intrapartum fever.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chorioamnionitis']}, 'descriptionModule': {'briefSummary': 'Retrospective Chart Review to determine the selective use of antibiotics in neonates born to mothers with suspected chorioamnionitis', 'detailedDescription': 'To determine the incidence and types of adverse outcomes in infants born to mothers with signs of chorioamnionitis when these infants are asymptomatic and are not treated with antibiotics empirically.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD'], 'maximumAge': '42 Weeks', 'minimumAge': '35 Weeks', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients born at Women's Hospital/Cone Health in Greensboro, NC, from July, 2012 (when EMR was implemented), to present.", 'genderDescription': 'Mother/baby in which the mother was diagnosed with chorioamnionitis and/or had intrapartum fever', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Mother/baby dyads in which the mother was diagnosed with chorioamnionitis and/or had intrapartum fever (as diagnosed by obstetrician)\n\nExclusion Criteria: None'}, 'identificationModule': {'nctId': 'NCT03576560', 'acronym': 'Chorio', 'briefTitle': 'Selective Use of Antibiotics in Neonates Born to Mothers With Suspected Chorioamnionitis', 'organization': {'class': 'OTHER', 'fullName': 'Pediatrix'}, 'officialTitle': 'Selective Use of Antibiotics in Neonates Born to Mothers With Suspected Chorioamnionitis', 'orgStudyIdInfo': {'id': '16NE-Z035-6145'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Retrospective Chart Review', 'type': 'OTHER', 'description': 'Retrospective Chart Review'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27408-7079', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': "Women's Hospital of Greensboro", 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}], 'overallOfficials': [{'name': 'John Wimmer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MEDNAX Employee'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pediatrix', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}