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

NCT06424795 | Completed

• 1 other identifier: MISP 58711-062022-002
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Syncytial Virus Infection

Keywords

wheeze

Outcome Measures

Primary Outcomes (1)

• Medically confirmed recurrent wheeze

  Recurrent wheezing documented by a medical provider following primary RSV infection

  Follow-up for recurrent wheeze begins 6 weeks after the primary RSV infection and ends approximately one year later (including a subsequent RSv season).

Study Arms (2)

Infants with recurrent wheeze

Infants with recurrent wheeze in the year following primary RSV infection

Infants without recurrent wheeze

Infants without recurrent wheeze in the year following primary RSV infection

Eligibility Criteria

• Age: 3 Days - 10 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study will enroll previously healthy infants born after 36 0/7 weeks gestation during their first RSV infection

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642-0001, United States

Location

Related Publications (2)

• Hall CB, Weinberg GA, Iwane MK, Blumkin AK, Edwards KM, Staat MA, Auinger P, Griffin MR, Poehling KA, Erdman D, Grijalva CG, Zhu Y, Szilagyi P. The burden of respiratory syncytial virus infection in young children. N Engl J Med. 2009 Feb 5;360(6):588-98. doi: 10.1056/NEJMoa0804877.

  PMID: 19196675 BACKGROUND

• Turi KN, Shankar J, Anderson LJ, Rajan D, Gaston K, Gebretsadik T, Das SR, Stone C, Larkin EK, Rosas-Salazar C, Brunwasser SM, Moore ML, Peebles RS Jr, Hartert TV. Infant Viral Respiratory Infection Nasal Immune-Response Patterns and Their Association with Subsequent Childhood Recurrent Wheeze. Am J Respir Crit Care Med. 2018 Oct 15;198(8):1064-1073. doi: 10.1164/rccm.201711-2348OC.

  PMID: 29733679 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Two anterior nasal swabs and a nasal brush. Samples retained only if agreed to by Legally Authorized Representative on Parent Permission form

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections; Respiratory Sounds

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mary T Caserta

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 22, 2024
• Study Start: December 21, 2019
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: May 22, 2024

Record last verified: 2024-05

Locations

US (1)