Actively Recruiting

Age: 0Months - 12Months
All Genders
NCT06636955

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

220 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Acute bronchiolitis in infants, mainly caused by the Respiratory Syncytial Virus (RSV), is a public health issue, in terms of morbidity and hospital costs. Nirsevimab, a long-acting antibody against RSV available for all infants under 12 months, could profoundly modify the epidemiology of the next epidemic seasons, with the increase of the frequency of the other respiratory viruses (endemic Coronaviruses, Metapneumovirus, etc) Monitoring viral ecology is important, as the impact of respiratory infections on morbidity in the short, medium and long term, but also in economic terms. Infants under the age 12 months with a first episode of bronchiolitis and consulting the emergency pediatric department will be included. A nasopharyngeal swab will be performed as routine care, and clinical data will be collected. Multiplex Polymerase Chain Reaction will be performed to identify respiratory virus(es) responsible for the bronchiolitis. In hospitalized infants with RSV or rhinovirus positive Polymerase Chain Reaction (PCR), daily nasal washes will be collected to perform viral loads with specific quantitative PCR (nasal washes biobank), associated with daily clinical data. A 12-month follow-up is planned for every infant included, consisting with 4 phone calls, to identify factors associated with the onset of preschool wheezing. The main objective is to describe the viral epidemiology associated with acute bronchiolitis leading to a pediatric emergency department visit the implementation of Nirsevimab.

CONDITIONS

Official Title

Viral Epidemiology of Bronchiolitis After Nirsevimab Implementation and Respiratory Evolution in Infants

Who Can Participate

Age: 0Months - 12Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Infant aged 12 months or less
  • Admitted to pediatric emergency services during one of the epidemic years 2024-2025, 2025-2026, or 2026-2027
  • Clinical diagnosis of first episode of acute bronchiolitis by the emergency pediatrician
  • Nasopharyngeal swab performed for virological diagnosis
Not Eligible

You will not qualify if you...

  • Parents refuse to allow their infant to participate in the study
  • Parents refuse follow-up phone calls
  • No nasopharyngeal swab taken from the infant

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Rouen University Hospital

Rouen, France, 76000

Actively Recruiting

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Research Team

H

Hortense PETAT, Doctor

CONTACT

C

Cécile Pourcher

CONTACT

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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