Evaluation of Moderate to Severe Influenza Outcomes in Children

Completed

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

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Moderate-to-severe Influenza	Respiratory nasal swab	Children 6 weeks to 8 years of age with influenza-like illness and one of the following: 1. Fever \>39 2. Lower respiratory tract infection 3. Acute otitis media 4. Serious extra-pulmonary manifestations (myositis, encephalitis)
Mild Influenza	Respiratory nasal swab	Children 6 weeks to 8 years of age with influenza-like illness (ILI) without the criteria for moderate-to-severe disease (above)

Primary Outcome Measures

Name	Time	Method
Hospitalization	0-14 days	Hospitalization within 14 days of influenza infection diagnosis

Secondary Outcome Measures

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

Locations (2): Children's Hospital Colorado
🇺🇸
Aurora, Colorado, United States
Children's Hospital North Campus Urgent Care
🇺🇸
Broomfield, Colorado, United States