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

January 13, 2015 updated by: Serdar Alan, Ankara University

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

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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Ankara University School of Medicine, Department of Pediatrics, Division of Neonatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 days to 2 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospitalized RSV infected newborn infants in the NICU.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Patients will be followed during hospitalization, with expected average of 3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: Patients will be followed during hospitalization, with expected average of 3 weeks
mortality related to RSV infection and epidemics
Patients will be followed during hospitalization, with expected average of 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara University

Investigators

  • Study Director: Omer Erdeve, MD, Ankara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

July 26, 2013

First Submitted That Met QC Criteria

August 1, 2013

First Posted (Estimate)

August 2, 2013

Study Record Updates

Last Update Posted (Estimate)

January 14, 2015

Last Update Submitted That Met QC Criteria

January 13, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TurkNICU-RSV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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