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Completed

NCT Number: NCT04008823

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

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

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Key information

Study type

Observational

Primary location

Iis Biodonostia

San Sebastián, Guipuzcoa, 20014, Spain

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Retrospective and observational epidemiological study, by review of clinical histories,

Other

Retrospective and observational epidemiological study, by review of clinical histories,

Primary outcomes

  1. To study the rate of hospitalizations for influenza virus infection in children under 15 years of age in third level hospitals in Spain.

    Time frame: 2014-2016

    Number of hospitalizations in children under 15 years old due to influenza virus infection

Secondary outcomes

  1. 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

    Time frame: 2014-2016

  2. Demographic characteristics of hospitalizations for influenza in children

    Time frame: 2014-2016

    Age, sex, weight

  3. Complications associated with influenza infection.

    Time frame: 2014-2016

  4. Related morbidity

    Time frame: 2014-2016

  5. Estimation of direct costs

    Time frame: 2014-2016

    • Income costs and prescribed medication.
    • Test costs.
    • Bed and UCIP costs.
    • Costs previous visits (to hospitalization) to the emergency room
  6. Epidemiological characteristics of hospitalizations for influenza in children

    Time frame: 2014-2016

    Presence or absence of seasonal influenza vaccination.

  7. Clinical characteristics of hospitalizations for influenza in children

    Time frame: 2014-2016

    • Presence / absence in microbiological analysis of influenza virus.
    • Coinfections.
    • Presence or absence of complications during hospitalization.
    • Variables of clinical evolution.
    • Analytical variables.

Sponsors and collaborators

Lead sponsor

Biogipuzkoa Health Research Institute

Other

Registry information

Official study title

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

Acronym: HOSPIGRIP

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 5, 2019
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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