Evaluation of Moderate to Severe Influenza Outcomes in Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Moderate to Severe Influenza Disease in Children 6 Months to 8 Years in Colorado

Conditions
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Influenza, Otitis Media, Lower Resp Tract Infection, Encephalitic Infection, Myositis Viral, Fever

Intervention / Treatment
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* Procedure: Respiratory nasal swab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 6 months to < 8 years Presentation to one of the study sites with signs and symptoms of influenza-like illness (temperature of >37.8⁰C and at least one of the following: cough, sore throat, runny nose or nasal congestion) Parents or guardians agreeing and consenting to medical information release, respiratory specimen collection and testing, email/phone call follow up and collection of leftover blood samples obtained during routine clinical care Patients seen during the 2016-2017 influenza season Exclusion Criteria: Respiratory symptom duration > 14 days Nurse only visit Enrollment in the study within prior 14 days

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Moderate-to-severe Influenza<br>Children 6 weeks to 8 years of age with influenza-like illness and one of the following: Fever >39 Lower respiratory tract infection Acute otitis media Serious extra-pulmonary manifestations (myositis, encephalitis) | Procedure: Respiratory nasal swab<br>* 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.<br>* Other names: Nasal swab;|
| Mild Influenza<br>Children 6 weeks to 8 years of age with influenza-like illness (ILI) without the criteria for moderate-to-severe disease (above) | Procedure: Respiratory nasal swab<br>* 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.<br>* Other names: Nasal swab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization | Hospitalization within 14 days of influenza infection diagnosis | 0-14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU Admission | Admission to the intensive care unit after influenza diagnosis | 0-14 days | 
| Antiviral Use | Antiviral use in children presenting to the ED or urgent care with influenza | 0-14 days | 
| Antibiotic Use | Antibiotic use in children presenting to the ED or urgent care with influenza | 0-14 days | 
| Recurrent Visits | Recurrent visits to the ED or healthcare provider in children presenting to the ED or urgent care with influenza | 0-14 days | 
| School Absenteeism | Absenteeism from school or daycare in patients presenting to the ED or urgent care with influenza | 0-14 days | 
| Work Absenteeism | Absenteeism from work in caregivers of children presenting to the ED or urgent care with influenza | 0-14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hospitalization, intensive care unit, school absenteeism, work absenteeism