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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

670 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-02-28

Study Completion Date

2030-02-28

Brief Summary

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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.

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Detailed Description

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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

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Rhinovirus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Younger Community Cohort (12-36 months of age)

Quarterly Surveillance Nasal Swabs and Nasal Swabs targeted around respiratory symptoms for up to 36 months of age, participants will provide one anterior and one mid-turbinate nasal swab sample

Nasal Swab Healthy Surveillance

Intervention Type DIAGNOSTIC_TEST

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.

Nasal Swab Sick Samples

Intervention Type DIAGNOSTIC_TEST

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

Sick Follow-up Survey

Intervention Type OTHER

Caregivers are surveyed 7-13 days after sick sample collection

Hospitalized Cohort of Infants and Children

Generally healthy infants and children hospitalized for respiratory illness will provide one anterior and one mid-turbinate nasal swab sample

Nasal Swab Hospitalized Cohort

Intervention Type DIAGNOSTIC_TEST

2 nasal swabs collected upon consent, one anterior and one mid-turbinate

Older Community Cohort (5 to 17 years of age)

Age-matched controls for older children in the Hospitalized Group, will be called upon as needed based on enrollment of hospitalized patients

Older Cohort Control Group

Intervention Type OTHER

Participants will be enrolled as needed based on enrollment of hospitalized patients

Interventions

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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.

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

Nasal Swab Hospitalized Cohort

2 nasal swabs collected upon consent, one anterior and one mid-turbinate

Intervention Type DIAGNOSTIC_TEST

Sick Follow-up Survey

Caregivers are surveyed 7-13 days after sick sample collection

Intervention Type OTHER

Older Cohort Control Group

Participants will be enrolled as needed based on enrollment of hospitalized patients

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

* 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.

* 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

* 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.

* Born prematurely, less than 32 weeks 0 days gestational age

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes