An observational study in Influenza, Otitis Media and Lower Resp Tract Infection, sponsored by University of Colorado, Denver. Completed at 2 sites in United States. Open to participants aged 6 Months to 8 Years. Per ClinicalTrials.gov, last updated 2021-02-04.
Sponsored by University of Colorado, Denver · Observational
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.
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 1,478 is above the median of 240 across 2,136 observational studies indexed under Infections.
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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.
Exclusion Criteria:
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)
Procedure: 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)
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.
Also known as: Nasal swab
Hospitalization
Hospitalization within 14 days of influenza infection diagnosis
Time frame: 0-14 days
ICU Admission
Admission to the intensive care unit after influenza diagnosis
Time frame: 0-14 days
Antiviral Use
Antiviral use in children presenting to the ED or urgent care with influenza
Time frame: 0-14 days
Antibiotic Use
Antibiotic use in children presenting to the ED or urgent care with influenza
Time frame: 0-14 days
Recurrent Visits
Recurrent visits to the ED or healthcare provider in children presenting to the ED or urgent care with influenza
Time frame: 0-14 days
School Absenteeism
Absenteeism from school or daycare in patients presenting to the ED or urgent care with influenza
Time frame: 0-14 days
Work Absenteeism
Absenteeism from work in caregivers of children presenting to the ED or urgent care with influenza
Time frame: 0-14 days
Injectable Influenza Vaccine (IIV) Hospitalization
Hospitalization among children who received IIV presenting to the ED or urgent care with influenza.
Time frame: 0-14 days
Recruitment occurred from January 30, 2017 until 5 May of 2018 including 2 influenza seasons at the Children's Hospital Colorado main Emergency Department and a peripheral Urgent Care Center
| Milestone | Moderate-to-severe Influenza | Mild Influenza |
|---|---|---|
| Started | 313 | 98 |
| Completed | 313 | 98 |
| Not completed | 0 | 0 |
Hospitalization within 14 days of influenza infection diagnosis
| Participants | Moderate-to-severe Influenza | Mild Influenza |
|---|---|---|
| Hospitalization | 26 | 2 |
Admission to the intensive care unit after influenza diagnosis
| Participants | Moderate-to-severe Influenza | Mild Influenza |
|---|---|---|
| ICU Admission | 3 | 0 |
Antiviral use in children presenting to the ED or urgent care with influenza
| Participants | Moderate-to-severe Influenza | Mild Influenza |
|---|---|---|
| Antiviral Use | 63 | 17 |
Antibiotic use in children presenting to the ED or urgent care with influenza
| Participants | Moderate-to-severe Influenza | Mild Influenza |
|---|---|---|
| Antibiotic Use | 96 | 17 |
Recurrent visits to the ED or healthcare provider in children presenting to the ED or urgent care with influenza
| Participants | Moderate-to-severe Influenza | Mild Influenza |
|---|---|---|
| Recurrent Visits | 21 | 4 |
Absenteeism from school or daycare in patients presenting to the ED or urgent care with influenza
| Participants | Moderate-to-severe Influenza | Mild Influenza |
|---|---|---|
| School Absenteeism | 87 | 85 |
Absenteeism from work in caregivers of children presenting to the ED or urgent care with influenza
| Participants | Moderate-to-severe Influenza | Mild Influenza |
|---|---|---|
| Work Absenteeism | 71 | 63 |
Hospitalization among children who received IIV presenting to the ED or urgent care with influenza.
No measurements were reported for this outcome.
Collected over 14 days since enrollment until follow up. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Moderate-to-severe Influenza | 0/313 (0%) | 0/313 (0%) | 0/313 (0%) |
| Mild Influenza | 0/98 (0%) | 0/98 (0%) | 0/98 (0%) |
Influenza positive ONLY
| Age, Continuous(years) | Moderate-to-severe Influenza | Mild Influenza | Total |
|---|---|---|---|
| Median | 3.8 ± 1.8 | 4.8 ± 2.4 | 4 ± 1.8 |
| Sex: Female, Male(Participants) | Moderate-to-severe Influenza | Mild Influenza | Total |
|---|---|---|---|
| Female | 152 | 53 | 205 |
| Male | 161 | 45 | 206 |
| Race (NIH/OMB)(Participants) | Moderate-to-severe Influenza | Mild Influenza | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 24 | 14 | 38 |
| White | 93 | 15 | 108 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 196 | 69 | 265 |
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University of Colorado, Denver