Clinical trial NCT04811248: Respiratory Outcome of Infants With or Without Documented Wheezing During Bronchiolitis
Official title: Respiratory Outcome of Infants With or Without Documented Wheezing During Bronchiolitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Wheezing
Asthma in Children
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-03-23
Enrollment: 281
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: infant referred to emergency departement for bronchiolitis

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.

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).

Eligibility criteria: 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:

-

Primary outcomes:
measure: To assess whether diagnosis of wheezing from a recording of pulmonary auscultation is associated with the risk of childhood asthma
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Robert Debre Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Plamen BOKOV, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: