WheezOut: Respiratory Outcome of Infants With or Without Documented Wheezing During Bronchiolitis

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Recruiting
CT.gov ID
NCT04811248
Collaborator
(none)
281
1
48
5.9

Study Details

Study Description

Brief 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). 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.

Condition or Disease Intervention/Treatment Phase
  • Other: telephone call for parents of patients

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).

Study Design

Study Type:
Observational
Anticipated Enrollment :
281 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Respiratory Outcome of Infants With or Without Documented Wheezing During Bronchiolitis
Actual Study Start Date :
Jan 8, 2021
Anticipated Primary Completion Date :
Jan 8, 2024
Anticipated Study Completion Date :
Jan 8, 2025

Outcome Measures

Primary Outcome Measures

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

    recording of asthma diagnosis and atopic, allergic diseases

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 7 Years
Sexes Eligible for Study:
All
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.

Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Robert Debre Hospital Paris France 75019

Sponsors and Collaborators

  • Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Plamen BOKOV, MD PhD, Assistance Publique - Hôpitaux de Paris

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT04811248
Other Study ID Numbers:
  • APHP200931
  • IDRCB: 2020-A01482-37
First Posted:
Mar 23, 2021
Last Update Posted:
Oct 18, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 18, 2021