Immune and microbial environment profile in young infants with RSV bronchiolitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study analyzes mucosal and systemic immune markers in infants aged 0–6 months who are part of the ENVIE study. It collects nasopharyngeal swabs, fingertip blood samples, and, for eligible weight, additional blood for advanced immunological analyses. Researchers quantify innate and inflammatory mediators (including type I/II/III interferons, IL-6, TNF-alpha, IL-10) and local antibody levels, and profile the microbiome and virome using sequencing. The aim is to understand how the host immune response and microbial environment relate to RSV bronchiolitis in early infancy. The study compares RSV cases to appropriate controls and is conducted at multiple pediatric centers in France.

Why it matters

Who can join: the full rules

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.

Where it's running

• CHI Créteil
  Créteil, France Recruiting
• CHU Necker
  Paris, France Recruiting
• CHU Robert-Debré
  Paris, France Recruiting

Study contacts

• Study coordinator: Julie TOUBIANA, PhD
• Email: julie.toubiana@aphp.fr
• Phone: 01 44 49 57 44

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.