Study of Influenza Virus Infection in Children Hospitalized in Spain in Two Consecutive Influenza Seasons

Completed

• Conditions: Influenza Virus Infection

• Registration Number: NCT04008823
• Lead Sponsor: Biogipuzkoa Health Research Institute

Brief Summary

This is an epidemiological, retrospective and observational study, by reviewing clinical histories, of children hospitalized for influenza virus infection, their comorbidities and the treatments that have been performed

Detailed Description

A better knowledge in our environment of the characteristics of the Influenza virus infection in the pediatric age, the clinical aspects, risk factors, the evolutionary and prognostic aspects, of morbidity and the direct medical costs, can allow a better management of the disease and a greater awareness of the importance of vaccination against influenza in the healthy child

Study Timeline

• Study Start: 2017-10-05
• Primary Completion: 2017-11-02
• Study Completion: 2017-12-13
• Status Verified: 2019-07
• Study First Submitted: 2019-07-01
• Study First Submitted QC: 2019-07-03
• Last Update Submitted: 2019-07-03
• Study First Posted: 2019-07-05
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 907

Inclusion Criteria

• Boys and girls under 15 years of age.
• With a clinical diagnosis of influenza virus infection.
• With infection by influenza virus confirmed microbiologically.
• Hospitalized more than 24 hours

Exclusion Criteria

• Age equal to or greater than 15 years.
• That the clinical diagnosis is not influenza virus infection.
• Influenza virus not confirmed by microbiological diagnosis.
• Not hospitalized or hospitalized for less than 24 hours.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To study the rate of hospitalizations for influenza virus infection in children under 15 years of age in third level hospitals in Spain.	2014-2016	Number of hospitalizations in children under 15 years old due to influenza virus infection

Secondary Outcome Measures

Name	Time	Method
Related morbidity	2014-2016
Demographic characteristics of hospitalizations for influenza in children	2014-2016	Age, sex, weight
Complications associated with influenza infection.	2014-2016
Hospitalization rate by age groups (0-6 months, 6 months to 24 months, 2 to 6 years, 6 to 10 years and 10 to 15 years of age	2014-2016
Estimation of direct costs	2014-2016	* Income costs and prescribed medication.; * Test costs.; * Bed and UCIP costs.; * Costs previous visits (to hospitalization) to the emergency room
Epidemiological characteristics of hospitalizations for influenza in children	2014-2016	Presence or absence of seasonal influenza vaccination.
Clinical characteristics of hospitalizations for influenza in children	2014-2016	* Presence / absence in microbiological analysis of influenza virus.; * Coinfections.; * Presence or absence of complications during hospitalization.; * Variables of clinical evolution.; * Analytical variables.

Trial Locations

Locations (1)

Iis Biodonostia; 🇪🇸 San Sebastián, Guipuzcoa, Spain