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

NCT06112132 | Completed DMC

• 1 other identifier: OVNI
• Study Type: observational
• Target: 1,827
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bronchiolitis; Asthma; Pneumonia

Outcome Measures

Primary Outcomes (1)

• Number of children hospitalized for bronchiolitis

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

  1 year

Secondary Outcomes (7)

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

  1 year

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

  1 year

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

  1 year

• Evaluate severity case of hospitalized children

  1 year

• Clinical characteristics of hospitalized children

  1 year

Study Arms (3)

Children hospitalized for pneumonia

All children, under 24 months of age, hospitalized for pneumonia

Children hospitalized for asthma

All children, under 24 months of age, hospitalized for asthma

Children hospitalized for bronchiolitis

All children, under 12 months of age, hospitalized for bronchiolitis

Eligibility Criteria

• Age: 1 Day - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

children hospilalized for bronchiolitis or pneumonia or asthma

You may qualify if:

• 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.

You may not qualify if:

• \- Refusal to participate by patient relative or legal representative

Sponsors & Collaborators

• Sanofi: collaborator
• Association Clinique Thérapeutique Infantile du val de Marne: lead

Study Sites (1)

ACTIV

Créteil, 94000, France

Location

Related Publications (1)

• Jeziorski E, Ouziel A, Cotillon M, Bridonneau C, Bizot E, Basse C, Portefaix A, Dubos F, Bechet S, Domitien L, Jaillet C, Abrudan S, Kramer R, Gajdos V, Launay E, Basmaci R, Gillet Y, Cohen R, Levy C. Impact of Nirsevimab on Respiratory Syncytial Virus Bronchiolitis in Hospitalized Infants: A Real-World Study. Pediatr Infect Dis J. 2025 Apr 1;44(4):e124-e126. doi: 10.1097/INF.0000000000004630. Epub 2024 Nov 26.

  PMID: 39589139 RESULT

Related Links

• Impact of Nirsevimab on Respiratory Syncytial Virus Bronchiolitis in Hospitalized Infants: A Real-World Study

MeSH Terms

Conditions

Bronchiolitis; Pneumonia; Asthma

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Levy Corinne

  Association Clinique Thérapeutique Infantile du val de Marne

  STUDY DIRECTOR

• Jeziorski Eric

  CHU Montpellier, Service Urgence et Post-urgences pédiatrique

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 1, 2023
• Study Start: October 27, 2023
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

FR (1)