Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-26 @ 3:44 AM
Study NCT ID:
NCT01915394
Status:
COMPLETED
Last Update Posted:
2015-01-14
First Post:
2013-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Respiratory Syncytial Virus Infection in Neonatal Intensive Care Units Throughout Turkey: Prospective Multicenter Study (TurkNICU-RSV Trial)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018357', 'term': 'Respiratory Syncytial Virus Infections'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D018186', 'term': 'Pneumovirus Infections'}, {'id': 'D018184', 'term': 'Paramyxoviridae Infections'}, {'id': 'D018701', 'term': 'Mononegavirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-13', 'studyFirstSubmitDate': '2013-07-26', 'studyFirstSubmitQcDate': '2013-08-01', 'lastUpdatePostDateStruct': {'date': '2015-01-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospitalized Respiratory Syncytial Virus infected Newborn in the Neonatal Intensive Care Units, and its relation with possible epidemics.', 'timeFrame': 'Patients will be followed during hospitalization, with expected average of 3 weeks'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'Patients will be followed during hospitalization, with expected average of 3 weeks', 'description': 'mortality related to RSV infection and epidemics'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Respiratory Syncytial Virus Infections', 'Epidemics', 'Neonatal Intensive Care Unit', 'Newborn infants'], 'conditions': ['Respiratory Syncytial Virus Infections', 'Infections, Epidemics']}, 'referencesModule': {'references': [{'pmid': '23692714', 'type': 'BACKGROUND', 'citation': 'Oncel MY, Mutlu B, Kavurt S, Bas AY, Demirel N, Akyol M, Erdeve O, Dilmen U. Respiratory syncytial virus prophylaxis in preterm infants: a cost-effectiveness study from Turkey. Turk J Pediatr. 2012 Jul-Aug;54(4):344-51.'}, {'pmid': '20299133', 'type': 'BACKGROUND', 'citation': 'Dizdar EA, Aydemir C, Erdeve O, Sari FN, Oguz S, Uras N, Dilmen U. Respiratory syncytial virus outbreak defined by rapid screening in a neonatal intensive care unit. J Hosp Infect. 2010 Aug;75(4):292-4. doi: 10.1016/j.jhin.2010.01.013. Epub 2010 Mar 17.'}, {'pmid': '22727129', 'type': 'BACKGROUND', 'citation': 'Alan S, Okulu E, Kilic A, Atasay B, Arsan S. Palivizumab use during respiratory syncytial virus outbreak in the neonatal intensive care unit. J Hosp Infect. 2012 Aug;81(4):292-3. doi: 10.1016/j.jhin.2012.05.011. Epub 2012 Jun 20. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The principle purpose of this multicenter trial is to determine the definition, timing and the percentage of nosocomial RSV epidemics throughout Turkey. In addition, secondary purpose of the trial is to determine the prevention strategies of further spread of Respiratory Syncytial Virus (RSV) in the neonatal intensive care unit (NICU).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '90 Days', 'minimumAge': '5 Days', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hospitalized RSV infected newborn infants in the NICU.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed RSV infection with either RSV-strip test or polymerase chain reaction (PCR).\n* Admission to the NICU or hospitalized in the NICU between 1 October 2013 and 01 April 2014.\n\nExclusion Criteria:\n\n* Refused informed consent'}, 'identificationModule': {'nctId': 'NCT01915394', 'acronym': 'TurkNICU-RSV', 'briefTitle': 'Respiratory Syncytial Virus Infection in Neonatal Intensive Care Units Throughout Turkey: Prospective Multicenter Study (TurkNICU-RSV Trial)', 'organization': {'class': 'OTHER', 'fullName': 'Ankara University'}, 'officialTitle': 'Management of Hospitalized Respiratory Syncytial Virus (RSV) Infected Patients in the Neonatal Intensive Care Unit (NICU) and Control of Epidemics; TurkNICU-RSV Study: A Multicentric, Prospective Trial', 'orgStudyIdInfo': {'id': 'TurkNICU-RSV'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hospitalized Respiratory Syncytial Virus Infected Newborns', 'description': 'All admitted newborns to the neonatal intensive care unit (NICU) will be enrolled in the study'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara University School of Medicine, Department of Pediatrics, Division of Neonatology', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Omer Erdeve, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ankara University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Serdar Alan', 'investigatorAffiliation': 'Ankara University'}}}}