Molecular and Microbiome/Metagenome Correlates of Recurrent Wheeze in RSV Infected Infants
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Rochester
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Medically confirmed recurrent wheeze
Study Overview
Brief Summary
The goal of this observational study is to learn about further wheezing in infants with RSV infection.. The main question it aims to answer is:
If infant factors, the infant immune response in the nose and the bacteria that reside in the nose at the time of primary RSV infection can predict/classify infants with recurrent wheezing during the following year.
A secondary aim is to identify infant immune response factors in the nose and patterns of bacteria in the nose during primary RSV infection that may help us understand why recurrent wheezing occurs.
Researchers will compare infants with repeated episodes of wheezing to infants who do not have further wheezing.
Participants will be full term infants with their first RSV infection. We will collect information on the pregnancy and birth history as well as the signs and symptoms of RSV infection. Two nasal swabs and a nasal wash will be collected from the infants. Six weeks following the RSV infection we will begin contact with the families biweekly to determine if the infant has recurrent wheezing confirmed by a medical provider. Follow-up will continue for approximately 1 year, through a second winter season.
Detailed Description
Respiratory syncytial virus (RSV) causes yearly epidemics of respiratory infection with a significant burden of disease in those at the extremes of age. Infants with RSV infection develop a range of illness from mild or in apparent upper respiratory infections to severe lower respiratory disease with wheezing and/or pneumonia. RSV infection is the most common cause of hospitalization in infants in the US.
The great majority (85%) of hospitalized infants are diagnosed with bronchiolitis and 78% are noted to have wheezing. RSV infection leads to even greater outpatient utilization of medical care including Emergency Department visits (39-69 per 1000 under 6 months and 45-68 per 1000 from 6-11 months) and visits to pediatricians (108-157/1000 under 6 months and 160-194 per 1000 from 6-11 months).
Following primary RSV infection several epidemiological observations have identified an increased frequency of recurrent wheezing in 34 to 56% of infants.
The objectives of this study include:
Primary Objective: To test whether clinical factors, airway gene expression and microbiome/metagenome patterns in the nasal epithelium at the time of primary RSV infection can predict/classify infants with recurrent wheezing.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 3 Days to 10 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Signed informed consent by Legally Authorized Representative
- •Confirmed infection with RSV
- •Gestational age at birth 36 and 0/7 weeks or greater
- •No prior wheezing episodes
- •Negative for acute infection with SARS-CoV-2
- •First RSV season
Exclusion Criteria
- •Underlying disease (immune, cardiopulmonary, neuromuscular, renal) that would qualify for palivizumab
- •Receiving immunosuppressive medications
- •Live greater than 35 miles from University of Rochester Medical Center
- •Parental inability to read or understand English
Outcomes
Primary Outcomes
Medically confirmed recurrent wheeze
Time Frame: Follow-up for recurrent wheeze begins 6 weeks after the primary RSV infection and ends approximately one year later (including a subsequent RSv season).
Recurrent wheezing documented by a medical provider following primary RSV infection
Secondary Outcomes
No secondary outcomes reported
Investigators
Mary Caserta
Professor of Pediatrics
University of Rochester