The Rhinovirus Hospitalization and Investigation of Nasal-airway Omics (RHINO) Study
ConditionRhinovirus
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 17
SponsorUniversity of Wisconsin, Madison
About this trial
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 5-17.5 years will be enrolled for age-match comparison with the older hospitalized cohort.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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 17.5 years of age at the time of enrollment.
Disqualifiers
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
Trial population
Aim 1: Generally healthy male and female children 12 to 36 months of age living in Dane County and surrounding areas representative of the general demographics of the county. Aim 2a: Hospitalized male and female children between newborn and 17.5 years of age with acute onset lower respiratory tract infections. These children will span all demographic and socioeconomic groups. Aim 2b: Generally healthy male and female children 5 to 17.5 years of age living in Dane County and surrounding areas representative of the general demographics of the county.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Nasal Swab Healthy Surveillance
Diagnostic testFamilies 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
Diagnostic testCaregivers 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
Nasal Swab Hospitalized Cohort
Diagnostic test2 nasal swabs collected upon consent, one anterior and one mid-turbinate
Sick Follow-up Survey
Other interventionCaregivers are surveyed 7-13 days after sick sample collection
Older Cohort Control Group
Other interventionParticipants will be enrolled as needed based on enrollment of hospitalized patients
Procedural Comfort or Care
Other interventionFor hospitalized participants who opt to induce sputum, 3 medications will be used to obtain the sample, albuterol sulfate solution and hypertonic saline (3% solution) administered via nebulizer and and lidocaine spray (4% solution) via atomizer to the nose. For hospitalized participants with pneumonia who opt for research blood draw or induced sputum, optional administration of oral sucrose (Sweet-Ease) may occur at the discretion of the treating provider.
Treatment groups
670 Participants
are divided into 3 treatment groupsGroup A: Younger Community Cohort (12-36 months of age)3 interventions
Group B: Hospitalized Cohort of Infants and Children2 interventions
Group C: Older Community Cohort (5 to 17.5 years of age)1 intervention
Trial outcomes
Primary outcomes
1
Aim 1: Summary of Rhinovirus Types Identified in Community Cohort
To test study hypotheses, the study team will identify the circulating RV types in symptomatic and asymptomatic children.
Time frame
data collected up to 36 months2
Aim 1: Unique Nasal Transcriptomic Signature of Clinical Rhinovirus Infections
Time frame
data collected up to 36 monthsSecondary outcomes
1
Aim 2: Summary of Rhinovirus Types Identified in lower respiratory tract (LRT) infections and upper respiratory tract infections (URI), Reported as Percent in Common
To test the hypothesis that there will be an 80 percent overlap between RV types causing acute LRT and URI, investigators will compare all RV types identified in age-matched hospitalized and ambulatory children.
Time frame
data collected up to 36 months2
Aim 2: Proportion of Hospitalized Cohort with lower respiratory infections attributable to Rhinovirus
The investigators will use host nasal transcriptomics derived from symptomatic and asymptomatic children with RV infection to determine the proportion of age-matched hospitalized LRT infections actually attributable to RV.
Time frame
data collected up to 36 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Wisconsin, Madison
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Source ClinicalTrials.gov