Observing hospitalized children with bronchiolitis
National Observatory of Children Hospitalized for Bronchiolitis
This study is looking at hospitalized babies with bronchiolitis to see how their cases relate to a new vaccine during the 2023/2024 season.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2500 (estimated) |
| Ages | 1 Day to 12 Months |
| Sex | All |
| Sponsor | Association Clinique Thérapeutique Infantile du val de Marne Academic / other |
| Drugs / interventions | Nirsevimab |
| Locations | 1 site (Créteil) |
| Trial ID | NCT06112132 on ClinicalTrials.gov |
What this trial studies
This observational study aims to monitor and describe cases of children hospitalized for bronchiolitis during the 2023/2024 season, particularly in relation to routine immunization with Nirsevimab. It will involve multiple centers and focus on children under 12 months of age who are admitted from pediatric emergency departments. The study will collect data on cases associated with respiratory syncytial virus (RSV) and other viruses. The goal is to enhance understanding of bronchiolitis in the context of current immunization practices.
Who should consider this trial
Good fit: Ideal candidates for this study are children under 12 months of age who are hospitalized for acute bronchiolitis.
Not a fit: Patients who are older than 12 months or those whose guardians refuse participation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management and prevention strategies for bronchiolitis in young children.
How similar studies have performed: While this approach is observational, similar studies have successfully contributed to understanding bronchiolitis and its management.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children under 12 months of age * In one of the 6 study sites * From October 15, 2023 * For acute bronchiolitis 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
Where this trial is running
Créteil
- Activ — Créteil, France (Recruiting)
Study contacts
- Principal investigator: Jeziorski Eric — CHU Montpellier, Service Urgence et Post-urgences pédiatrique
- Study coordinator: Levy Corinne
- Email: corinne.levy@activ-france.fr
- Phone: 1 48 85 04 04
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.