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NCT07698769
ENVIEANCILLAIRE: Efficacy of Nirsevimab in Children Hospitalised With RSV Bronchiolitis - A Subsidiary Study on the Immune Signature and Microbial Environment
Conditions: Mucosal Cytokine Profile of Patients (Type I and III Interferons, Pro-inflammatory Cytokines)
Sex: All
Ages: 0 Months – 6 Months
Enrollment: 110
Sponsor: Centre Hospitalier Intercommunal Creteil
Location: CHI Créteil Créteil
Summary
Among children aged ≤ 6 months included in the ENVIE study, the ENVIE\_ancillaire study will be offered to cases of RSV infection or to controls. The study involves a nasopharyngeal swab using a FLOQ-SWAB™ swab and a fingertip sample (dextro type). These samples will be collected specifically for the purpose of studying immunity.
A blood sample may also be requested for children weighing ≥5 kg who are included in the ENVIE\_ancillaire study. The purpose of this sample collection will be to conduct an advanced immunological study
Eligibility Criteria
Inclusion Criteria:
* Written consent to take part in the study
* Registered with a social security scheme
Cases:
* Children aged 6 months or under included in the ENVIE study. Treated for bronchiolitis caused by RSV
* Admitted to hospital following a visit to the paediatric A\&E department
Control group:
Children aged 6 months or under included in the ENVIE study. Admitted to a standard ward or a Short-Stay Unit, or having attended the paediatric A\&E department
For one of the following reasons:
* Febrile urinary tract infection, without acute ENT or respiratory symptoms
* Acute gastroenteritis, without acute ENT or respiratory symptoms
* Infant colic without fever, without ENT or acute respiratory condition
* Weight stagnation or feeding difficulties without fever, without acute ENT or respiratory symptoms
* Neonatal jaundice without fever, without acute ENT or respiratory symptoms
* Unexplained crying without fever, without acute ENT or respiratory symptoms
* Head injury, without acute ENT or respiratory symptoms
* Admitted for acute surgical conditions, without fever, without acute ENT or respiratory symptoms
* Nappy rash, without fever, without acute ENT or respiratory symptoms
* Fracture, without fever, without acute ENT or respiratory symptoms.
Exclusion Criteria:
* Refusal to participate by the legal representative
* Administration of palivizumab
* Maternal vaccination against RSV.
Source: ClinicalTrials.gov (NCT07698769). StuddyBuddy aggregates publicly available trial information.