Respiratory Outcome of Infants With or Without Documented Wheezing During Bronchiolitis

NCT04811248 | Unknown

• 2 other identifiers: APHP200931IDRCB: 2020-A01482-37
• Study Type: observational
• Target: 281
• Locations: 1 country
• Sites: 1

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.

Conditions

Wheezing; Asthma in Children

Outcome Measures

Primary Outcomes (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

  1 year

Interventions

telephone call for parents of patients OTHER

telephone call for parents of patients aged 6 years old

Also known as: one groupe of infants having a bronchiolitis

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

infant referred to emergency departement for bronchiolitis

You may qualify if:

• Telephone numbers of the 2 parents available
• Informed parents who do not object to participation in research.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Robert Debre Hospital

Paris, 75019, France

RECRUITING

MeSH Terms

Conditions

Respiratory Sounds

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Plamen BOKOV, MD PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Plamen BOKOV, MD PhD

CONTACT

+33140032756; palmen.bokov@aphp.fr

Christophe DELCLOUX, MD PhD

CONTACT

+33140034190; christophe.delclaux@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 23, 2021
• Study Start: January 8, 2021
• Primary Completion: January 8, 2024
• Study Completion: January 8, 2025
• Last Updated: October 18, 2021

Record last verified: 2021-03

Locations

FR (1)