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

NCT ID: NCT01915394

Last Updated: 2015-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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Respiratory Syncytial Virus Infections Infections, Epidemics

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Hospitalized Respiratory Syncytial Virus Infected Newborns

All admitted newborns to the neonatal intensive care unit (NICU) will be enrolled in the study

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

5 Days

Maximum Eligible Age

90 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara University

OTHER

Sponsor Role lead

Responsible Party

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Serdar Alan

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Omer Erdeve, MD

Role: STUDY_DIRECTOR

Ankara University

Locations

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Ankara University School of Medicine, Department of Pediatrics, Division of Neonatology

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 23692714 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20299133 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22727129 (View on PubMed)

Other Identifiers

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TurkNICU-RSV

Identifier Type: -

Identifier Source: org_study_id

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