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NCT01915394 Clinical Trial

Respiratory Syncytial Virus Infection in Neonatal Intensive Care Units Throughout Turkey: Prospective Multicenter Study (TurkNICU-RSV Trial)

Respiratory Syncytial Virus Infections Clinical Trial

— TurkNICU-RSV  

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01915394
Other study ID # TurkNICU-RSV
Secondary ID
Status Completed
Phase N/A
First received July 26, 2013
Last updated January 13, 2015
Start date September 2013
Est. completion date June 2014

Study information
Verified date January 2015
Source Ankara University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ministry of Health
Study type Observational

Clinical Trial Summary

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).

Recruitment information / eligibility
Status Completed
Enrollment 250
Est. completion date June 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Both
Age group N/A to 90 Days
Eligibility Inclusion Criteria:

- Confirmed RSV infection with either RSV-strip test or polymerase chain reaction (PCR).

- Admission to the NICU or hospitalized in the NICU between 1 October 2013 and 01 April 2014.

Exclusion Criteria:

- Refused informed consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Turkey Ankara University School of Medicine, Department of Pediatrics, Division of Neonatology Ankara

Sponsors (1)
Lead Sponsor Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Alan S, Okulu E, Kiliç 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. — View 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. — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Hospitalized Respiratory Syncytial Virus infected Newborn in the Neonatal Intensive Care Units, and its relation with possible epidemics. Patients will be followed during hospitalization, with expected average of 3 weeks No
Secondary Mortality mortality related to RSV infection and epidemics Patients will be followed during hospitalization, with expected average of 3 weeks No
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