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

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ClinicalTrials.gov Identifier: NCT01915394
Recruitment Status : Completed
First Posted : August 2, 2013
Last Update Posted : January 14, 2015
Sponsor:
Information provided by (Responsible Party):
Serdar Alan, Ankara University

Brief 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).

Condition or disease
Respiratory Syncytial Virus Infections Infections, Epidemics

Study Type : Observational
Actual Enrollment : 250 participants
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
Study Start Date : September 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Group/Cohort
Hospitalized Respiratory Syncytial Virus Infected Newborns
All admitted newborns to the neonatal intensive care unit (NICU) will be enrolled in the study



Primary Outcome Measures :
  1. 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 :
  1. Mortality [ Time Frame: Patients will be followed during hospitalization, with expected average of 3 weeks ]
    mortality related to RSV infection and epidemics



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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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01915394


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

Publications:
Responsible Party: Serdar Alan, MD, Ankara University
ClinicalTrials.gov Identifier: NCT01915394     History of Changes
Other Study ID Numbers: TurkNICU-RSV
First Posted: August 2, 2013    Key Record Dates
Last Update Posted: January 14, 2015
Last Verified: January 2015

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

Additional relevant MeSH terms:
Infection
Communicable Diseases
Virus Diseases
Respiratory Syncytial Virus Infections
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections