Evaluation of Moderate to Severe Influenza Outcomes in Children
| Status: | Completed |
|---|---|
| Conditions: | Influenza, Other Indications, Infectious Disease, Infectious Disease, Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases, Other |
| Healthy: | No |
| Age Range: | Any - 8 |
| Updated: | 7/4/2018 |
| Start Date: | February 4, 2017 |
| End Date: | May 4, 2018 |
Evaluation of Moderate to Severe Influenza Disease in Children 6 Months to 8 Years in Colorado
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.
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.
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.
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
We found this trial at
2
sites
469 Colorado 7
Broomfield, Colorado 80023
Broomfield, Colorado 80023
Principal Investigator: Suchitra Rao, MD
Phone: 303-724-3285
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13123 E 16th Ave
Aurora, Colorado 80045
Aurora, Colorado 80045
(720) 777-1234
Principal Investigator: Suchitra Rao, MD
Phone: 303-724-3285
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