RHINO study: understanding rhinovirus causes of severe respiratory illness in kids

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study follows a community cohort of 120 children 12–36 months old for 36 months to track rhinovirus infections and collect nasal samples for virus identification and host transcriptomics. A hospitalized cohort of about 450 infants and children will be enrolled during years 1–3 to examine RV-related illness in the hospital, using paired nasal swabs to identify viruses and apply a host signature to distinguish RV-related illness from other causes. An additional 100 healthy children aged 5–17.5 years will serve as age-matched controls for comparison with older inpatients. The study aims to estimate RV burden and to develop a nasal transcriptome signature that differentiates symptomatic from subclinical infection.

Why it matters

Who can join: the full rules

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 17.5 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 17.5 years of age at the time of enrollment
* Has a diagnosis of bronchiolitis, asthma exacerbation, acute hypoxemic respiratory failure or community acquired pneumonia (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.
* Non-respiratory infection at the time of admission
* Neurologic disease (for example, cerebral palsy, genetic neurologic diseases, seizure disorder)

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

Where it's running

• University of Wisconsin
  Madison, Wisconsin, United States Recruiting

Study contacts

• Principal investigator: Ellen R Wald, MD — UW School of Medicine and Public Health
• Study coordinator: Research Nurses
• Email: reserachnurses@pediatrics.wisc.edu
• Phone: 608-228-4940

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.