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

Study of Influenza Virus Infection in Children Hospitalized in Spain in Two Consecutive Influenza Seasons. Analysis of Direct Medical Costs

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

Study Overview

• Status: Completed
• Conditions: Influenza Virus Infection
• Intervention / Treatment: Other: Retrospective and observational epidemiological study, by review of clinical histories,

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 Type: Observational
• Enrollment (Actual): 907

Contacts and Locations

Study Locations

• Spain
  • Guipuzcoa
    • San Sebastián, Guipuzcoa, Spain, 20014
      • Iis Biodonostia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

the population under study is children under 15 years of age, hospitalized for infection with influenza virus confirmed microbiologically during two consecutive seasons (September 15, 2014 to June 30, 2015) (September 15, 2015 to June 30, 2015). 2016).

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Demographic characteristics of hospitalizations for influenza in children	Age, sex, weight	2014-2016
Complications associated with influenza infection.		2014-2016
Related morbidity		2014-2016
Estimation of direct costs	Income costs and prescribed medication.; Test costs.; Bed and UCIP costs.; Costs previous visits (to hospitalization) to the emergency room	2014-2016
Epidemiological characteristics of hospitalizations for influenza in children	Presence or absence of seasonal influenza vaccination.	2014-2016
Clinical characteristics of hospitalizations for influenza in children	Presence / absence in microbiological analysis of influenza virus.; Coinfections.; Presence or absence of complications during hospitalization.; Variables of clinical evolution.; Analytical variables.	2014-2016

Collaborators and Investigators

• Sponsor: Asociacion Instituto Biodonostia

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2017
• Primary Completion (Actual): November 2, 2017
• Study Completion (Actual): December 13, 2017

Study Registration Dates

• First Submitted: July 1, 2019
• First Submitted That Met QC Criteria: July 3, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 3, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Disease Attributes; Orthomyxoviridae Infections; Infections; Communicable Diseases; Virus Diseases; Influenza, Human
• Other Study ID Numbers: HOSPIGRIP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No