NCT02979626

Evaluation of Moderate to Severe Influenza Outcomes in Children

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,478 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 6 Months – 8 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Influenza
• Otitis Media
• Lower Resp Tract Infection
• Encephalitic Infection
• Myositis Viral
• Fever

Interventions

Type	Name	Description
PROCEDURE	Respiratory nasal swab	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.

Timeline

• Start date: 2017-01-30
• Primary completion: 2018-05-04
• Completion: 2018-05-05
• First posted: 2016-12-01
• Last updated: 2021-02-04
• Results posted: 2021-02-04

Locations

2 sites across 1 country: United States