NCT07342582

The Rhinovirus Hospitalization and Investigation of Nasal-airway Omics (RHINO) Study

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 670 (estimated)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 17 Years
• Healthy volunteers: Accepted

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.

Detailed 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 transcriptomics. This will allow the investigators to create many samples from both symptomatic and asymptomatic infections. The samples will be used to develop a host signature to discriminate symptomatic and asymptomatic infection. Aim 2a: Involves the evaluation of generally healthy children hospitalized at AFCH with acute, lower respiratory tract infections including bronchiolitis, asthma and community acquired pneumonia. There will also be the evaluation of infants less than 6 months of age who may become ill with an RV syndrome. These children will be evaluated with two nasal swabs as above. This allows the identification of children infected with RV and other respiratory viruses. Application of the host signature developed in Aim 1 will determine the actual proportion of those children who are infected with RV whose illness (clinical symptoms) is caused by RV. Aim 2b: Involves the prospective creation of a cohort of generally healthy children 5 to 17 years old to be sampled on an as-needed basis to serve as age- and season-matched controls for the Hospitalized Group. To determine the frequency of virus infection with RV and other respiratory viruses, 2 healthy children will provide a single swab of the nasal mucosa within 2 weeks of each hospitalized participant who is 5-17 years of age. The one swab will be of the anterior nose and will be used for identification of viruses. Age matching will occur within 3 groups: * Ages 5-8 years old: n=50 * Ages 9-13 years old: n=30 * Ages 14-17 years old: n=20 Aim 3: Use parallel bulk and single cell RNA sequencing (scRNA-seq) to identify targetable processes of acute, severe LRT caused by RV. The investigators hypothesize that integrated bulk RNA-sequencing and scRNA-seq will identify immune/inflammatory defects and targets for intervention. Bulk and scRNA-seq on respiratory samples from well-characterized patients with severe RV disease will be performed to test this hypothesis and to compare samples obtained from those with non-severe disease.

Conditions

• Rhinovirus

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-05-01
• Primary completion: 2030-05-01
• Completion: 2030-05-01
• First posted: 2026-01-15
• Last updated: 2026-02-24

Locations

1 site across 1 country: United States