Examining the airway epithelium in children with post-infectious bronchiolitis obliterans

Morphological and Functional Pilot Study of the Bronchial Epithelium of Children With Post-infectious Bronchiolitis Obliterans

This study is trying to see if there are differences in the nose lining of young children who get sick from certain viruses and later develop post-infectious bronchiolitis obliterans compared to those who don’t.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 450 (estimated)
• Ages: 1 Month to 6 Years
• Sex: All
• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France (Government)
• Locations: 1 site (Marseille)
• Trial ID: NCT06140901 on ClinicalTrials.gov

What this trial studies

This study investigates the morphological and functional characteristics of the respiratory epithelium in children aged 1 month to 6 years who have been hospitalized with adenovirus or rhinovirus infections. The research aims to identify differences in the nasal epithelium of children who progress to post-infectious bronchiolitis obliterans (PIBO) compared to those who do not. By analyzing the airway epithelium, the study seeks to enhance understanding of the pathophysiology associated with PIBO, which is often diagnosed late and lacks established treatment protocols. The study is conducted at a single center, the Timone Enfant University Hospital in Marseille, France.

Who should consider this trial

Good fit: Ideal candidates are children aged 1 month to 6 years hospitalized with confirmed adenovirus or rhinovirus respiratory infections.

Not a fit: Patients who do not have a confirmed adenovirus or rhinovirus infection or are outside the age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnosis and management strategies for children at risk of developing post-infectious bronchiolitis obliterans.

How similar studies have performed: While the specific approach of this study is novel, similar studies have explored the impact of viral infections on respiratory health in children, indicating potential for meaningful insights.

Eligibility criteria

Inclusion Criteria:

1. Children from 1 month to 6 years hospitalized at the Timone Enfant University Hospital
2. Diagnosis of an adenovirus or rhinovirus respiratory infection confirmed on a nasal swab, made upon arrival as part of the child's initial care
3. Consent form read, understood, approved and signed by parents before any study procedure
4. Affiliation to a social security scheme or beneficiary of such a scheme

The inclusion criteria for children who were not hospitalized when diagnosed with an adenovirus and rhinovirus respiratory infection at the Timone Enfant University Hospital are:

1. Children from 1 month to 6 years old transferred to the Timone Enfant University Hospital
2. Show the following signs:

   has. Clinical: clinical signs persist 6 weeks after a viral infection: tachypnea, wheezing and/or persistent hypoxemia b. Scan: mosaic appearance +/- bronchiectasis, atelectasis vs. +/- EFR if performed: obstructive ventilatory disorder not or only slightly reversible after bronchodilators
3. Consent form read, understood, approved and signed by parents before any study procedure
4. Affiliation to a social security scheme or beneficiary of such a scheme

Exclusion Criteria:

1. Refusal of participation in the study by the family will be a reason for non-inclusion, as well as in the absence of parental authority.
2. The existence of an underlying chronic pulmonary pathology (e.g. cystic fibrosis, ciliary dyskinesia).
3. A coagulation pathology.

Where this trial is running

Marseille

• Aphm — Marseille, France (Recruiting)

Study contacts

• Principal investigator: Julie MAZENQ, PhD — APHP Marseille
• Study coordinator: Julie MAZENQ, PhD

Conditions Bronchiolitis Obliterans; children; post infectious