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Can airway cell clues predict a rare lung disease in children?

NCT ID NCT06140901

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This study looks at children aged 1 month to 6 years who are hospitalized with a severe respiratory infection caused by adenovirus or rhinovirus. The goal is to compare the airway cells of those who develop a rare lung condition called post-infectious bronchiolitis obliterans (PIBO) with those who do not. Researchers will collect nasal samples and, in children who develop PIBO, also take bronchial biopsies and washings to examine the cells' shape and function. The hope is to understand why some children get PIBO and to find early signs that could lead to faster diagnosis.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Nasal swab and brushing, bronchial biopsies, and bronchoalveolar lavage (diagnostic procedures)
What this could lead to
If successful, this could help identify early markers that predict which children with adenovirus or rhinovirus infections will develop bronchiolitis obliterans, potentially leading to earlier diagnosis and better management.
What could go wrong
This is a small pilot study, so findings may not be definitive or generalizable. The procedures are invasive and carry risks, and the study does not test a treatment, so it may not directly change patient care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 450 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 month to 6 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • APHM

    RECRUITING

    Marseille, 13000, France

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