NCT01286285

Surveillance of Influenza in Paediatric Intensive Care Units in Bavaria

An Active, Epidemiological Surveillance Study on Influenza-related Hospitalizations to Intensive Care Units and Fatalities in Paediatric Hospitals in Bavaria Covering the Influenza Seasons 2010/2011 and 2011/2012

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,140 (estimated)
• Sponsor: University Children's Hospital, Wuerzburg · Academic / Other
• Sex: All
• Age: 1 Month – 16 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to assess the number of severe, laboratory-confirmed influenza in children hospitalized to paediatric intensive care units. Furthermore, the proportion of these children from all children hospitalized to paediatric intensive care units with acute respiratory infections will be established.

Detailed description

Accurate epidemiological data on severe influenza-associated hospitalizations and fatalities in children are lacking in Germany. The purpose of this study is primarily, to assess the number of severe, laboratory-confirmed influenza in children hospitalized to paediatric intensive care units due to suspected acute respiratory infections/ influenza/ influenza-triggered complications and in children developing influenza during paediatric intensive care unit hospitalization, as well as the number of influenza-associated fatalities. In addition we aim at assessing clinical features, severity, risk factors, complications, diagnostic procedures, treatment and outcome of severe, laboratory-confirmed influenza (and other acute respiratory infections) in these children. Another objective is to estimate the proportion of laboratory-confirmed influenza cases in all children hospitalized to paediatric intensive care units with acute respiratory infections and to evaluate the number and proportion of paediatric intensive care unit hospitalizations due to other viral acute respiratory infections. Additional aims are to estimate the (minimum) incidence of severe influenza-associated hospitalizations in Bavarian children and to estimate the (minimum) incidences of other acute respiratory infections. Ideally, this study will be conducted between October 2010 and March 2012 in all Bavarian (Germany) hospitals with paediatric intensive care units or paediatric intensive care beds (neonatology excluded). To optimize reporting there will be one study physician at each site responsible for documentation, diagnostic procedures and queries. The local study physician will receive an initiation visit at the start of each season, and will be contacted by the study coordination (situated at the University Children's Hospital in Wuerzburg) bi-weekly by phone. This local study physician summarizes the paediatric intensive care unit admittance in a log sheet, documents epidemiological, demographical, and clinical data in a questionnaire for all suspected acute respiratory infections/influenza patients with parental informed consent (pseudonymous data only), and draws a nasopharyngeal swab or -wash if indicated as routine procedure. A sample will be sent to the central laboratory (Institute for Virology and Immunobiology, University of Wuerzburg) for analysis (influenza-polymerase chain reaction, influenza virus subtyping, other viral acute respiratory infections (respiratory syncytial virus, parainfluenza 1-4, humane metapneumovirus, adenoviruses, rhinoviruses, enteroviruses). The central laboratory will analyse the samples timely and report the results to the respective study site. Additional influenza-tests may also be performed by the local laboratory, at the discretion of the hospitals. All tests, locally and performed in Wuerzburg, and their outcome should be reported in the questionnaire.

Conditions

• Influenza
• Acute Respiratory Infection

Timeline

• Start date: 2010-10-01
• Completion: 2012-03-01
• First posted: 2011-01-31
• Last updated: 2011-01-31

Locations

1 site across 1 country: Germany