NCT04008823

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
907

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 5, 2017

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2017

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

28 days

First QC Date

July 1, 2019

Last Update Submit

July 3, 2019

Conditions

Outcome Measures

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.

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

    2014-2016

Secondary Outcomes (7)

  • 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

    2014-2016

  • Complications associated with influenza infection.

    2014-2016

  • Related morbidity

    2014-2016

  • Estimation of direct costs

    2014-2016

  • +2 more secondary outcomes

Interventions

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

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Iis Biodonostia

San Sebastián, Guipuzcoa, 20014, Spain

Location

MeSH Terms

Interventions

Retrospective Studies

Intervention Hierarchy (Ancestors)

Case-Control StudiesEpidemiologic StudiesEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesCohort StudiesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2019

First Posted

July 5, 2019

Study Start

October 5, 2017

Primary Completion

November 2, 2017

Study Completion

December 13, 2017

Last Updated

July 5, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations