Respiratory Syncytial Virus Infections Clinical Trial
— TurkNICU-RSVOfficial 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
| Verified date | January 2015 |
| Source | Ankara University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Turkey: Ministry of Health |
| Study type | Observational |
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).
| 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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Turkey | Ankara University School of Medicine, Department of Pediatrics, Division of Neonatology | Ankara |
| Lead Sponsor | Collaborator |
|---|---|
| Ankara University |
Turkey,
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
| 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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