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

This study has been completed.
Information provided by (Responsible Party):
Serdar Alan, Ankara University Identifier:
First received: July 26, 2013
Last updated: January 13, 2015
Last verified: January 2015
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).

Respiratory Syncytial Virus Infections
Infections, Epidemics

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:

Further study details as provided by Serdar Alan, Ankara University:

Primary Outcome Measures:
  • Hospitalized Respiratory Syncytial Virus infected Newborn in the Neonatal Intensive Care Units, and its relation with possible epidemics. [ Time Frame: Patients will be followed during hospitalization, with expected average of 3 weeks ]

Secondary Outcome Measures:
  • Mortality [ Time Frame: Patients will be followed during hospitalization, with expected average of 3 weeks ]
    mortality related to RSV infection and epidemics

Enrollment: 250
Study Start Date: September 2013
Study Completion Date: June 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Hospitalized Respiratory Syncytial Virus Infected Newborns
All admitted newborns to the neonatal intensive care unit (NICU) will be enrolled in the study


Ages Eligible for Study:   up to 90 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospitalized RSV infected newborn infants in the NICU.

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01915394

Ankara University School of Medicine, Department of Pediatrics, Division of Neonatology
Ankara, Turkey, 06100
Sponsors and Collaborators
Ankara University
Study Director: Omer Erdeve, MD Ankara University School of Medicine
  More Information

Responsible Party: Serdar Alan, MD, Ankara University Identifier: NCT01915394     History of Changes
Other Study ID Numbers: TurkNICU-RSV
Study First Received: July 26, 2013
Last Updated: January 13, 2015

Keywords provided by Serdar Alan, Ankara University:
Respiratory Syncytial Virus Infections
Neonatal Intensive Care Unit
Newborn infants

Additional relevant MeSH terms:
Communicable Diseases
Virus Diseases
Respiratory Syncytial Virus Infections
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections processed this record on May 25, 2017