Идёт набор NCT06636955

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

— Наблюдательное Acute Bronchiolitis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: biobank, follow up.
Кому может быть актуально: Состояния в реестре: Acute Bronchiolitis. Базовые параметры: 0 мес. — 12 мес. · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

Другое biobank
* nasopharyngeal swab collection * nasopharyngeal nasal washes collection, during hospitalization, if any
Другое follow up
\- one year follow up: after 1 month, 3 months, 6 months et 12 months

Первичные конечные точки

The primary endpoint will be the prevalence of viral populations identified by respiratory multiplex PCR ( nasopharyngeal swab) in the group with Nirsevimab and in the group without Nirsevimab [Срок оценки: 3 years]

Критерии участия

Критерии включения

Infant aged 12 months or less
Admitted to the pediatric emergencies services during one of the three epidemic years: 2024-2025, 2025-2026 and 2026-2027
With clinical diagnosis of first episode of acute bronchiolitis by the emergency pediatrician
With nasopharyngeal swab for virological diagnosis