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Molecular and Microbiome/Metagenome Correlates of Recurrent Wheeze in RSV Infected Infants

NCT06424795 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2024-05-22

No results posted yet for this study

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.

Conditions

  • Respiratory Syncytial Virus Infection

Sponsors & Collaborators

  • University of Rochester

    lead OTHER

Principal Investigators

  • Mary T Caserta · University of Rochester

Eligibility

Min Age
3 Days
Max Age
10 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-21
Primary Completion
2024-04-01
Completion
2024-04-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06424795 on ClinicalTrials.gov