Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT06039618
Status:
COMPLETED
Last Update Posted:
2023-09-18
First Post:
2023-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Capabilities of Perinatal Healthcare Institutions in the Federation of Bosnia and Herzegovina
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22897}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-15', 'studyFirstSubmitDate': '2023-09-06', 'studyFirstSubmitQcDate': '2023-09-09', 'lastUpdatePostDateStruct': {'date': '2023-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Referral to a centre of higher organizational level.', 'timeFrame': 'Before birth and up to 4 hours or more after delivery.', 'description': 'Referring the neonate with low birth weight to a more specialized centre.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prenatal Care']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the level of the perinatal healthcare institution (PHI) where the newborns were delivered. We included newborns of both genders that were born in the maternity wards in 10 cantons of the Federation of Bosnia and Herzegovina (FBiH). From the PHI of the first and second level, 159 newborns were referred to the third level. Out of a total of 159 LBWI referred from other PHI, only 19.5% LBWI were transported in less than 4 hours. In second level PHI, most LBWI died in the first 12 hours after birth.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '42 Weeks', 'minimumAge': '22 Weeks', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Newborns that were born in the maternity wards of the Federation of Bosnia and Herzegovina', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newborns of both genders that were born in the maternity wards in 10 cantons of the FBiH\n* A gestational age between 22 and 42 weeks, and a birth weight less than 2500g.\n\nExclusion Criteria:\n\n* Infants younger than 22 weeks or older than 42 weeks.\n* Infants whose mothers refused to give consent for participation in the study.'}, 'identificationModule': {'nctId': 'NCT06039618', 'briefTitle': 'Capabilities of Perinatal Healthcare Institutions in the Federation of Bosnia and Herzegovina', 'organization': {'class': 'OTHER', 'fullName': 'Evangelisches Krankenhaus Bethesda zu Duisburg'}, 'officialTitle': 'Capabilities of Perinatal Healthcare Institutions in Primary and Tertiary Care of Low Birth Weight Infants in the Federation of Bosnia and Herzegovina: A Cross-sectional Multicentric Study.', 'orgStudyIdInfo': {'id': '02-09/2-77/20'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Referred to a Centre of Higher Level', 'description': 'Those are the newborns that were referred at the time of delivery or within one week after birth to centers of higher organizational level.', 'interventionNames': ['Other: Referral to Centre of Higher Organizational Level']}, {'label': 'Treated at the Centre of Admission', 'description': 'Those are the newborns that were not referred to other centers and were treated in the health facility were the birth took place, and hospitalized in the same center until discharge.'}], 'interventions': [{'name': 'Referral to Centre of Higher Organizational Level', 'type': 'OTHER', 'description': 'Referral to Centre of Higher Organizational Level. This means referral from a primary neonatal care center to a secondary one, or from the secondary to the tertiary center.', 'armGroupLabels': ['Referred to a Centre of Higher Level']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tešanj', 'country': 'Bosnia and Herzegovina', 'facility': 'General Hospital Tešanj', 'geoPoint': {'lat': 44.61191, 'lon': 17.98552}}], 'overallOfficials': [{'name': 'Anis Cerovac, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'General Hospital Tešanj'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Evangelisches Krankenhaus Bethesda zu Duisburg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant', 'investigatorFullName': 'Antoine Naem', 'investigatorAffiliation': 'Evangelisches Krankenhaus Bethesda zu Duisburg'}}}}