An observational study in Acute Bronchiolitis, sponsored by University Hospital, Rouen. Recruiting at 1 site in France. Open to participants aged 0 Months to 12 Months. Per ClinicalTrials.gov, last updated 2024-10-15.
Sponsored by University Hospital, Rouen · Observational
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.
289 studies on the registry are indexed under Bronchiolitis; 51 are open to participants now.
This study's planned enrollment of 900 is above the median of 200 across 79 observational studies indexed under Bronchiolitis.
Browse Bronchiolitis studies →University Hospital, Rouen is the lead sponsor of 418 studies on the registry; 106 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Infant with acute bronchiolitis
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Exclusion Criteria:
Patients having received a passive immunization
Other: biobank · Other: follow up
Patients not having received a passive immunization
Other: biobank · Other: follow up
* nasopharyngeal swab collection * nasopharyngeal nasal washes collection, during hospitalization, if any
- one year follow up: after 1 month, 3 months, 6 months et 12 months
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
Multiplex Polymerase Chain Reaction (nasopharyngeal swab) in the 2 groups
Time frame: 3 years
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2024 (actual). Primary completion is estimated for Oct 2027, 36 months after the start.
Of 26 observational studies under Bronchiolitis, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 87. This study's planned 36 months is above that.
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