National Observatory of Children Hospitalized for Acute Respiratory Distress or Lower Respiratory Tract Infections

Association Clinique Thérapeutique Infantile du val de Marne1,827 enrolled

Overview

This study is an observational, multicenter and prospective study for surveillance of case of hospitalised children acute respiratory distress or lower respiratory tract infections

The aim of this surveillance is to observe and describe cases of children hospitalized for bronchiolitis or pneumonia or asthma in the context of Nirsevimab immunization and according to RSV status

Study Type

OBSERVATIONAL

Enrollment

1,827

Conditions

Bronchiolitis Pneumonia Asthma

Eligibility

Sex: ALLMin age: 1 DayMax age: 24 Months

Medical Language ↔ Plain English

Inclusion Criteria: * Children under 12 months of age for bronchiolitis or under 24 months of age for pneumonia or under 24 months of age for asthma * Hospitalized in one of the 12 study sites * From October 15, 2023 * For acute bronchiolitis or pneumonia or asthma defined according to current national and international recommendations * Hospitalized from the pediatric emergency department. Exclusion Criteria: \- Refusal to participate by patient relative or legal representative

Locations (1)

ACTIV

Créteil, France

Outcomes

Primary Outcomes

Number of children hospitalized for bronchiolitis

Assessment of the number of children hospitalized for bronchiolitis in the context of Nirsevimab immunization.

Time frame: 1 year

Secondary Outcomes

Proportion of children under 12 months hospitalized for bronchiolitis based on different age groups

Assessment of population of children under 12 months hospitalized for bronchiolitis according to their Nirsevimab and RSV status, based on different age groups (under 3 months, 3-6 months, 6-12 months).

Time frame: 1 year

Proportion of children under 24 months hospitalized for pneumonia based on different age groups

Assessment of population of children under 24 months hospitalized for pneumonia, according to their Nirsevimab (first or second-year's immunization) and RSV status based on different age groups.

Time frame: 1 year

Proportion of children under 24 months hospitalized for asthma based on different age groups

Assessment of population of children under 24 months hospitalized for asthma according to their Nirsevimab (first or second-year's immunization) and RSV status, based on different age groups.

Time frame: 1 year

Evaluate severity case of hospitalized children

Assessment of severity case of bronchiolitis or pneumonia or asthma according to RSV and Nirsevimab immunization status (first or second-year's immunization) and according to age groups.

Time frame: 1 year

Clinical characteristics of hospitalized children

Assesment of children medical care hospitalised for bronchiolitis or pneumonia or asthma (use of ventilatory support, associated treatment,...) in France (entire population) according to RSV and Nirsevimab immunization status (first or second-year's immunization).

Data from ClinicalTrials.gov

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