Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2026-02-23 @ 1:12 AM
Study NCT ID:
NCT02061150
Status:
UNKNOWN
Last Update Posted:
2014-02-12
First Post:
2014-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neonatal Sepsis Workup for High Risk Newborns - Evaluation of Need and Ways to Prevent
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071074', 'term': 'Neonatal Sepsis'}], 'ancestors': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-02-11', 'studyFirstSubmitDate': '2014-02-11', 'studyFirstSubmitQcDate': '2014-02-11', 'lastUpdatePostDateStruct': {'date': '2014-02-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Asymptomatic newborns that underwent sepsis workup', 'timeFrame': '3 years', 'description': 'The number of. asymptomatic newborns that underwent sepsis workup due to maternal risk factors only will be determined'}], 'secondaryOutcomes': [{'measure': 'Positive blood cultures out of total cultures', 'timeFrame': '3 years', 'description': 'Percentage of positive blood cultures out of the total cultures that were taken.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Early onset GBS sepsis', 'Prevention', 'Maternal risk factors'], 'conditions': ['Neonatal Sepsis']}, 'descriptionModule': {'briefSummary': 'Sepsis is a significant cause of morbidity and mortality among newborns. Due to strict criteria and in order to diagnose and prevent early-onset group B streptococcal (EOGBS) sepsis, many infants undergo a sepsis workup due to risk factors alone, even though they are asymptomatic. Our goal is to evaluate the number of newborns that undergo sepsis workup due to risk factors alone, to determine the number of newborns having positive blood cultures, and to establish ways to reduce the number of asymptomatic infants undergoing sepsis workup.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '48 Hours', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Asymptomatic term/near term newborns to a mother with infectious risk factors such as premature rupture of membranes, GBS-carrier etc, that underwent sepsis work up due to their maternal risk factors,', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nTerm newborns with blood cultures taken from them the first 48 hrs\n\nExclusion Criteria:\n\n* Preterm newborns\n* Septic/ill appearing newborns\n* Newborns requiring admission to NICU'}, 'identificationModule': {'nctId': 'NCT02061150', 'briefTitle': 'Neonatal Sepsis Workup for High Risk Newborns - Evaluation of Need and Ways to Prevent', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'orgStudyIdInfo': {'id': 'HYMC-104-13'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Asymptomatic newborns that had sepsis workup', 'description': 'Evaluation of medical records of asymptomatic newborns that had sepsis workup in the first 48 hours of life.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '38100', 'city': 'Hadera', 'country': 'Israel', 'contacts': [{'name': 'Amit Hochberg, MD', 'role': 'CONTACT', 'email': 'amith@hy.health.gov.il', 'phone': '+972-4-6304320'}, {'name': 'Amit Hochberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Michael Feldman, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Erez Nadir, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sylvia Foldi, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The Hillel Yaffe Medical Center', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}], 'centralContacts': [{'name': 'Amit Hochberg, MD', 'role': 'CONTACT', 'email': 'amith@hy.health.gov.il', 'phone': '+972-4-6304320'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}