Evaluation of Moderate to Severe Influenza Outcomes in Children
Condition: Influenza; Otitis Media; Lower Resp Tract Infection; Encephalitic Infection; Myositis Viral; Fever
MeSH terms: Infections; Communicable Diseases; Influenza, Human; Myositis; Otitis Media
Study type: Observational

Summary: 
      The purpose of this study was to determine whether moderate-severe endpoints (including high
      fever, lower respiratory tract disease, acute otitis media, or serious extra-pulmonary
      complications) were predictive of hospitalization, intensive care admission, antibiotic use
      and other complications in children under 8 years of age.
    

Detailed description: 
      This prospective observational study aimed to determine the risk difference of
      hospitalization due to moderate to severe influenza compared with mild influenza among
      children aged 6 months to 8 years who were evaluated at Children's Hospital Colorado
      emergency department and urgent care during the 2016-2017 influenza season. In addition, the
      study intended to evaluate the risk difference for other health outcomes such as ICU
      admission, antibiotic and antiviral use, caregiver and child absenteeism and recurrent (>1)
      healthcare visits, and to compare the healthcare costs associated with management of moderate
      to severe versus mild influenza in children. Children who presented to Children's Hospital
      Colorado Emergency Department (ED) and urgent care affiliated sites (North Campus urgent
      care) with an influenza-like illness from December 2016 to April 2017 and during the
      2016-2017 influenza season, were eligible for the study. Once enrolled in the study, the
      investigators collected respiratory samples (nasal swab specimens) for influenza testing by
      PCR, sociodemographic and clinical data including variables of interest outlined above, and
      followed the clinical outcome of these children for 14 days after their initial presentation.
      Some of the variables of interest the investigators collected are shown below.
    

Intervention name(s): Respiratory nasal swab
Intervention type(s): Procedure
Intervention description(s): Nasal swabs will be obtained for testing by the study nurses. If a respiratory sample has already been collected as part of routine clinical care, this will replace the study collection, and no additional testing will be required.
Other intervention name(s): Nasal swab
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children 6 months to 8 years of age and younger seeking evaluation and management of
        influenza-like illness (ILI) at any of the study sites will be eligible for participation
        in the study. The study will commence during the influenza season as determined by the
        department of microbiology and epidemiology at CHCO (the influenza season commences when
        there are 3 positive influenza PCR tests within a week), approximately from December 1,
        2016 to April 30, 2017.
      
Biospecimen description: 
      Respiratory swab samples
    
Keywords: hospitalization; intensive care unit; school absenteeism; work absenteeism