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WheezingWheezOutNCT04811248

Respiratory Outcome of Infants With or Without Documented Wheezing During Bronchiolitis

An observational study of Wheezing and Asthma in Children, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Hospital admission for infant bronchiolitis is associated with an increased risk of recurrent wheezing and subsequent asthma in childhood. In the literature, 17 to 60% of children will develop repeated wheezing (infant asthma in France). Read more about this study

Who is it for?
Ages 3 to 7 years
Conditions the study is for
Wheezing, Asthma in Children
What is being tested?
telephone call for parents of patients
How many people
281 participants
Where
1 siteFrance
Study dates
8 Jan 2021to 8 Jan 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 7 years
  • All sexes
  • Child

Study population: infant referred to emergency departement for bronchiolitis

Who may be able to join

  • Children included in the WheezSmart study at Robert Debré Hospital • Diagnosis at inclusion of bronchiolitis
  • Telephone numbers of the 2 parents available
  • Informed parents who do not object to participation in research.

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Plamen BOKOV, MD PhD contact

+33140032756

palmen.bokov@aphp.fr

Christophe DELCLOUX, MD PhD contact

+33140034190

christophe.delclaux@aphp.fr

France1 site, 1 recruiting
  • Robert Debre Hospital

    Paris, 75019

    Christophe Delclaux, MD PhD, +33 1 40 03 41 90, christophe.declaux@aphp.fr

    Recruiting

Other trials in France

About this study

Hospital admission for infant bronchiolitis is associated with an increased risk of recurrent wheezing and subsequent asthma in childhood. In the literature, 17 to 60% of children will develop repeated wheezing (infant asthma in France). This highly variable incidence could be linked in part to the fact that the definition of bronchiolitis varies between continents. In Europe the usual definition is an acute and contagious viral infection which affects the bronchioles (small bronchi) of infants accompanied by coughing, rapid breathing and wheezing. In research studies, bronchiolitis must be associated with wheezing and / or crackles on auscultation in Europe, and wheezing imperatively in the USA. The diagnosis of wheezing is difficult, and medical agreement on auscultatory respiratory abnormalities is poor. We thus have developed a wheezing diagnostic tool using artificial intelligence processing of respiratory sound recordings by smartphone (Bokov P, Comput Biol Med 2016, DOI: 10.1016/j.compbiomed.2016.01.002). In a second larger bicentric study that included only infants suspected of bronchiolitis, our approach has consisted in obtaining a recording by smartphone but also by electronic stethoscope in order to allow deferred listening of the sounds (WheezSmart study). The objective of these studies was to obtain a formal diagnosis of wheezing, the current project aims to assess the benefit of this diagnosis. The main objective of this cross-sectional study is to determine whether the formal presence (diagnosis of wheezing from a recording of pulmonary auscultation) is associated with the risk of childhood asthma (diagnosis of asthma at 6 years) regardless of the usual risk factors (atopic / allergic terrain, exposure to smoking, recurrence of symptoms). The secondary objectives are to determine whether the formal presence of wheezing on auscultation is a risk factor for subsequent repeated wheezing (diagnosis of infant asthma) and for initial disease severity (bronchiolitis) compared to SpO2 and admission of the child to hospital. The interest in differentiating between high and low frequency sibilants will be evaluated also.

Read the detailed description

Hospital admission for infant bronchiolitis is associated with an increased risk of recurrent wheezing and subsequent asthma in childhood. In the literature, 17 to 60% of children will develop repeated wheezing (infant asthma in France). This highly variable incidence could be linked in part to the fact that the definition of bronchiolitis varies between continents. In Europe the usual definition is an acute and contagious viral infection which affects the bronchioles (small bronchi) of infants accompanied by coughing, rapid breathing and wheezing. In research studies, bronchiolitis must be associated with wheezing and / or crackles on auscultation in Europe, and wheezing imperatively in the USA. The diagnosis of wheezing is difficult, and medical agreement on auscultatory respiratory abnormalities is poor. We thus have developed a wheezing diagnostic tool using artificial intelligence processing of respiratory sound recordings by smartphone (Bokov P, Comput Biol Med 2016, DOI: 10.1016/j.compbiomed.2016.01.002). In a second larger bicentric study that included only infants suspected of bronchiolitis, our approach has consisted in obtaining a recording by smartphone but also by electronic stethoscope in order to allow deferred listening of the sounds (WheezSmart study). The objective of these studies was to obtain a formal diagnosis of wheezing, the current project aims to assess the benefit of this diagnosis. The main objective of this cross-sectional study is to determine whether the formal presence (diagnosis of wheezing from a recording of pulmonary auscultation) is associated with the risk of childhood asthma (diagnosis of asthma at 6 years) regardless of the usual risk factors (atopic / allergic terrain, exposure to smoking, recurrence of symptoms). The secondary objectives are to determine whether the formal presence of wheezing on auscultation is a risk factor for subsequent repeated wheezing (diagnosis of infant asthma) and for initial disease severity (bronchiolitis) compared to SpO2 and admission of the child to hospital. The interest in differentiating between high and low frequency sibilants will be evaluated also. Population: Children from 3 to 7 years old. Inclusion criteria: • Children included in the WheezSmart study at Robert Debré Hospital • Diagnosis at inclusion of bronchiolitis • Telephone numbers of the 2 parents available • Informed parents who do not object to participation in research. Population of wheezsmart study: 281 children diagnosed with bronchiolitis at Robert Debré Hospital for whom we have a recording of respiratory sounds. Statistical analyses: Comparison of the proportions of infant asthma then asthma in the groups with and without wheezing (chi-square tests). For the two groups with and without wheezing, the SpO2 means and the hospital admission rate will be compared (t and chi-square test).

Being tested
telephone call for parents of patients
Medical subject headings
Respiratory Sounds

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • telephone call for parents of patientsOther

    Also called one groupe of infants having a bronchiolitis

    telephone call for parents of patients aged 6 years old

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To assess whether diagnosis of wheezing from a recording of pulmonary auscultation is associated with the risk of childhood asthma

    recording of asthma diagnosis and atopic, allergic diseases

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2021
  2. Study start8 Jan 2021
  3. Primary completion8 Jan 2024 (estimated)
  4. Study completion8 Jan 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
281 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04811248
Sponsor's protocol ID
APHP200931
Other IDs
IDRCB: 2020-A01482-37
Acronym
WheezOut
Status last verified
Mar 2021
First submitted
19 Mar 2021
Last updated
18 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Wheezing and Asthma in Children, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Plamen BOKOV, MD PhD (+33140032756, palmen.bokov@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess whether diagnosis of wheezing from a recording of pulmonary auscultation is associated with the risk of childhood asthma (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2021.

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