Acute Bronchiolitis in Infants and Allergic Asthma

Asthma Clinical Trial

Official title:

Risk of Allergic Asthma Occurring in the Long Term From an Episode of Acute Bronchiolitis in Infants: Clinical, Allergological and Functional Evaluation in the Long Term

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03915197
• Other study ID #: CHU-433
• Secondary ID: 2018-A02659-46
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2, 2019
• Est. completion date: October 30, 2023

Study information

• Verified date: April 2019
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise LACLAUTRE
• Phone: 0473754963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Predicting the risk of allergenic sensitizations and asthma development in the first year of life is difficult.

Investigator decided to follow prospectively two cohorts of infants with acute bronchiolitis, hospitalized or treated at home, from the epidemic seasons of 2011-2012 and 2015-2017 to know their respiratory evolution, especially if they developed allergen sensitization and / or asthma.

Description:

Follow-up consultation 6 years after an episode of acute bronchiolitis at Clermont-Ferrand hospital with:

• Consultation with a pneumopediatrician: collection of respiratory symptoms, respiratory treatments, evaluation of the atopic site and environmental risk factors for bronchial aggression, especially passive smoking;

• Physical examination ;

• Evaluation of precariousness during the same interview with the EPICES questionnaire;

• Prick tests with positive control (histamine) and negative (physiological saline) and prick for the main pneumallergens (mites, alternaria, grasses, cat and dog) and trophallergens (egg, milk, fish, soy, wheat, peanut);

• Blood test with blood count, determination of specific IgE (5 pneumallergens and 5 trophallergens), dosage of sRAGE;

• Fonctionnal respiratory test with reversibility test

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 320
• Est. completion date: October 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 9 Years

Eligibility

Inclusion Criteria:

• Acute bronchiolitis in an infant less than one year old, included in studies KL6 (winter period 2011-2012) or CC16 (winter period 2015-2016) at clermont-ferrand hospital.

Exclusion Criteria:

• Bronchopulmonary dysplasia;

• History of prematurity <34 AS;

• Mucoviscidosis;

• known immune deficiencies;

• Primary ciliary dyskinesia suspected;

• Congenital heart disease;

• Acute renal failure.

• Refusal of parents to participate

Related Conditions & MeSH terms

• Acute Bronchiolitis
• Allergy
• Asthma
• Bronchiolitis

Intervention

Diagnostic Test:
• Pneumological evaluation
Consultation with a pneumopediatrician: collection of respiratory symptoms, respiratory treatments, evaluation of the atopic site and environmental risk factors for bronchial aggression, especially passive smoking

Locations

Country	Name	City	State
France	Chu Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk factors for asthma 6 years after an episode of acute bronchiolitis	Presence / absence of asthma 6-9 years after an episode of bronchiolitis during the first year of life; The diagnosis of asthma is established during a consultation by a pneumopediatrician on the following criteria: =3 documented respiratory symptoms = 2 times; Or an episode lasting = 4 weeks; With symptoms: tachypnea, wheezing, expiratory stridor, signs of chest retraction or wheezing diagnosed by a doctor.	at 6 years
Secondary	Correlation between onset of asthma and severity of bronchiolitis	Severity of acute bronchiolitis, assessed by a clinical score based on control signs, spO2 and respiratory rate (Wainwright score) and the length of hospital stay	at 6 years
Secondary	relationship between KL-6 serum markers and the occurrence of longer-term asthma	Correlation between onset of asthma and concentration of KL-6 during bronchiolitis	at 6 years
Secondary	relationship between CC16 serum markers and the occurrence of longer-term asthma	Correlation between onset of asthma and concentration of CC16 during bronchiolitis.	at 6 years
Secondary	relationship between sRAGE serum markers and the occurrence of longer-term asthma	Correlation between onset of asthma and concentration of sRAGE during bronchiolitis	at 6 years