Actively Recruiting

Phase Not Applicable
Age: 1Month - 6Years
All Genders
ID06140901

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

Led by Institut National de la Santé Et de la Recherche Médicale, France · Updated on 2025-04-25

450

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Bronchiolitis obliterans (BO) is a rare, irreversible lung condition that causes blockage or closure of small airways, often developing in children after serious lower respiratory infections, mainly from adenovirus or rhinovirus. This study aims to understand the damage to the respiratory lining in children who develop post-infectious bronchiolitis obliterans (PIBO) compared to those who do not. Researchers hypothesize that the nasal lining's structure differs between these groups and seek to characterize these differences over time. The study involves children aged 1 month to 6 years hospitalized with adenovirus or rhinovirus infections, divided into two groups: those who develop PIBO and those who do not. At the start, all children will have nasal swabs and brushings. Children who develop PIBO will undergo additional procedures including nasal brushing, bronchial biopsies, and bronchoalveolar washing at diagnosis and again after six months if treatment response is partial. This observational study follows participants over an average of three years. Participants will be closely monitored through clinical assessments, nasal and bronchial tissue examinations, and laboratory analyses to evaluate inflammation, antiviral responses, and changes in respiratory epithelium. Researchers will study how the nasal and bronchial linings change over time in PIBO cases and analyze molecular profiles from biopsies. The main outcome is defining the extent of epithelial damage in PIBO, with ongoing evaluation of inflammatory and antiviral factors during the study period.

CONDITIONS

Brief Title

Bronchial Epithelium of Children With Post-infectious Bronchiolitis Obliterans

Who Can Participate

Age: 1Month - 6Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged from 1 month to 6 years hospitalized at the Timone Enfant University Hospital
  • Diagnosis of adenovirus or rhinovirus respiratory infection confirmed by nasal swab upon arrival
  • Parents have read, understood, and signed the consent form before any study procedures
  • Affiliated to or beneficiary of a social security scheme
  • Children aged 1 month to 6 years transferred to the Timone Enfant University Hospital
  • Clinical signs persisting 6 weeks after viral infection such as rapid breathing, wheezing, and/or persistent low oxygen
  • Scan showing mosaic pattern, bronchiectasis, or atelectasis
  • If performed, lung function tests showing obstructive ventilatory disorder not or slightly reversible after bronchodilators
Not Eligible

You will not qualify if you...

  • Family refuses participation or lacks parental authority
  • Presence of chronic lung diseases such as cystic fibrosis or ciliary dyskinesia
  • Presence of coagulation or bleeding disorders

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Through study completion, an average of 3 years

Participants undergo morphological and functional studies of the respiratory epithelium to assess differences related to adenovirus or rhinovirus infection and progression to PIBO.

Assessments occur as scheduled throughout the study period

Long-term Monitoring

Duration - Through study completion, an average of 3 years

Participants are followed over time to monitor the morphology of the nasal and bronchial epithelia and evaluate pro-inflammatory and antiviral mediators involved in disease progression.

Ongoing assessments during the study duration

Trial Site Locations

Total: 1 location

1

APHM

Marseille, France, 13000

Actively Recruiting

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Research Team

J

Julie MAZENQ, PhD

D

Delphine Gras

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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