Trial record 4 of 19 for:    Open Studies | "Respiratory Syncytial Virus Infections"

Management of Hospitalized Respiratory Syncytial Virus (RSV) Infected Patients in the Neonatal Intensive Care Unit (NICU) and Control of Epidemics: TurkNICU-RSV Trial

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2013 by Ankara University
Sponsor:
Information provided by (Responsible Party):
Serdar Alan, Ankara University
ClinicalTrials.gov Identifier:
NCT01915394
First received: July 26, 2013
Last updated: August 1, 2013
Last verified: August 2013
  Purpose

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
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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mortality [ Time Frame: Patients will be followed during hospitalization, with expected average of 3 weeks ] [ Designated as safety issue: No ]
    mortality related to RSV infection and epidemics


Estimated Enrollment: 1000
Study Start Date: September 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Hospitalized Respiratory Syncytial Virus Infected Newborns
All admitted newborns to the neonatal intensive care unit (NICU) will be enrolled in the study

  Eligibility

Ages Eligible for Study:   up to 90 Days
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01915394

Contacts
Contact: Serdar Alan, MD +905325991259 alanserdar@gmail.com
Contact: Omer Erdeve, MD +905054812151 omererdeve@yahoo.com

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
  More Information

Publications:
Responsible Party: Serdar Alan, MD, Ankara University
ClinicalTrials.gov Identifier: NCT01915394     History of Changes
Other Study ID Numbers: TurkNICU-RSV
Study First Received: July 26, 2013
Last Updated: August 1, 2013
Health Authority: Turkey: Ministry of Health

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

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

ClinicalTrials.gov processed this record on July 28, 2014