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NCT07342582

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

Sponsor: University of Wisconsin, Madison

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

Any - 17 Years

Study Type

OBSERVATIONAL

Enrollment

670

Start Date

2026-05

Completion Date

2030-05

Last Updated

2026-02-24

Healthy Volunteers

Yes

Conditions

Rhinovirus

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

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 provide informed consent in English. * Admitted to American Family Children's Hospital (AFCH) within the past 24 hours * Children under 18 years of age at the time of enrollment * Has a diagnosis of bronchiolitis, asthma exacerbation or CAP OR is an infant less than 6 months of age with fever greater than 38 degrees Celsius within 24 hours of hospital admission Exclusion Criteria (all participants): * Congenital or currently acquired immunosuppressive condition or medications (e.g., congenital immunodeficiency, Leukemia, Lupus) * Congenital anomalies that might alter frequency of infection (e.g., unrepaired cleft palate, bronchial cyst, pulmonary sequestration) * Presence of tracheostomy or gastrostomy tube * Previously enrolled a different group in the study * Other child in the same household already enrolled in the study * Not suitable for study participation due to other reasons at the discretion of the investigators. Exclusion Criteria (Aim 1: Community Group Only): * History of chronic pulmonary diseases (e.g., asthma, cystic fibrosis, bronchopulmonary dysplasia (BPD)) (Note: asthma IS exclusionary) * Acute upper respiratory symptoms within the past week (7 days) at the time of enrollment Exclusion Criteria (Aim 2: Hospitalized Group Only): * History of chronic pulmonary diseases, excluding asthma (e.g., cystic fibrosis, bronchopulmonary dysplasia (BPD)) (Note: asthma is NOT exclusionary) * A positive test for any virus other than RV within the 48 hours prior to and including admission. Exclusion Criteria (less than 5 years old only (All participants in Aim 1 and some participants in Aim 2a): * Born prematurely, less than 32 weeks 0 days gestational age

Locations (1)

University of Wisconsin

Madison, Wisconsin, United States

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (1)