Actively Recruiting
Viral Epidemiology of Bronchiolitis After Nirsevimab Implementation and Respiratory Evolution in Infants
Led by University Hospital, Rouen · Updated on 2024-10-15
900
Participants Needed
1
Research Sites
64 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying acute bronchiolitis in infants, mainly caused by the Respiratory Syncytial Virus (RSV), which is a significant health concern due to its impact on illness and hospital costs. This study aims to understand how the use of Nirsevimab, a long-acting antibody for infants under 12 months, affects the spread of RSV and other respiratory viruses during future epidemic seasons. The research focuses on viral patterns and the respiratory health evolution in infants over time. Infants aged 12 months or younger who experience their first episode of bronchiolitis and visit the pediatric emergency department will be included. Nasopharyngeal swabs will be taken as part of routine care to identify the viruses causing bronchiolitis using a multiplex Polymerase Chain Reaction test. Hospitalized infants testing positive for RSV or rhinovirus will have daily nasal washes collected for viral load measurement. Participants will be divided into groups based on whether they received passive immunization with Nirsevimab. Each infant will be followed for 12 months, with clinical data collected through four phone calls to track respiratory health and the onset of preschool wheezing. Researchers will monitor viral populations and clinical symptoms and evaluate the impact of respiratory infections on short and long-term health and economic factors. The main outcome measured is the prevalence of viruses identified in infants with and without Nirsevimab over three years.
CONDITIONS
Brief Title
Viral Epidemiology of Bronchiolitis After Nirsevimab Implementation and Respiratory Evolution in Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infant aged 12 months or less
- Admitted to pediatric emergency services during the 2024-2027 epidemic years
- Clinical diagnosis of first episode of acute bronchiolitis by emergency pediatrician
- Nasopharyngeal swab taken for virus testing
You will not qualify if you...
- Parents refuse participation for their infant
- Parents refuse follow-up phone calls
- No nasopharyngeal swab taken
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - During hospitalization if any
Participants provide nasopharyngeal swabs and, if hospitalized, nasal washes to collect viral samples.
1 visit during hospitalization
Duration - 1 year
Participants are followed up to monitor respiratory evolution and viral epidemiology.
Visits at 1 month, 3 months, 6 months, and 12 months
Trial Site Locations
Total: 1 location
1
Rouen University Hospital
Rouen, France, 76000
Actively Recruiting
Research Team
H
Hortense PETAT, Doctor
C
Cécile Pourcher
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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