Identifying the Burden of Hospitalization Due to Rhinovirus (RV) in Children and Mechanisms of Pathogenesis Using Airway Molecular Profiling

University of Wisconsin, Madison

Summary

The goal of this study is to determine the burden of Rhinoviruses (RVs) as a cause of acute, severe, respiratory illnesses leading to hospitalization. A community cohort of 120 children between 12 and 36 months of age will be enrolled in the first year of the study and followed (when well and sick) for 36 months to identify the circulating RVs and provide samples to establish a host nasal transcriptome differentiating clinical from subclinical RV infections. A hospitalized cohort of 450 infants and children will be enrolled during years 1 through 3 of the study and followed for the duration of their hospitalization to investigate the findings of the community cohort. An additional 100 healthy children aged 5-17 years will be enrolled for age-match comparison with the older hospitalized cohort.

Description

Aim 1: Involves the prospective creation of a cohort of generally healthy children 12 to 36 months to be followed longitudinally for 36 months in an observational study. To determine the frequency of virus infection with RV and other respiratory viruses, children will have two swabs of the nasal mucosa performed whenever they develop an acute respiratory illness (upper respiratory symptoms lasting more than 24 hours) and four times a year for surveillance. One swab will be of the anterior nose and will be used for identification of viruses, and a second mid-turbinate swab will be used for host…

Eligibility

Age range: Up to 17 years
Sex: All
Healthy volunteers: Yes

Detailed criteria

Inclusion Criteria (Aim 1 and Aim 2b Community Groups): * Parent/legal guardian is willing and able to provide informed consent in English. * Willing to comply with all study procedures and be available for the duration of the study. * Younger Community Group: Generally healthy children 12 to 36 months of age at the time of enrollment * Older Community Group: Generally healthy children 5 to 17 years of age at the time of enrollment. * Current patient within primary care system at UW Health Inclusion Criteria (Aim 2a: Hospitalized Group): * Parent/legal guardian is willing and able to provid…

Interventions

Diagnostic Test
Nasal Swab Healthy Surveillance
Families will be asked to collect nasal swabs from their children during specified surveillance months (February, April, September, and December). Caregivers will be instructed to only collect surveillance samples during these months if and when children have been free of respiratory symptoms for at least two weeks prior to sampling. Caregiver surveys are part of quarterly surveillance.
Diagnostic Test
Nasal Swab Sick Samples
Caregivers will be instructed to watch for respiratory symptoms and collect nasal swabs 24-48 hours after symptom onset. Caregiver surveys are part of sick sample collection
Diagnostic Test
Nasal Swab Hospitalized Cohort
2 nasal swabs collected upon consent, one anterior and one mid-turbinate
Other
Sick Follow-up Survey
Caregivers are surveyed 7-13 days after sick sample collection
Other
Older Cohort Control Group
Participants will be enrolled as needed based on enrollment of hospitalized patients

Location

University of Wisconsin
Madison, Wisconsin