Acute Bronchiolitis in Infants and Allergic Asthma

Not Applicable

• Conditions: Acute Bronchiolitis; Allergy; Asthma

• Registration Number: NCT03915197
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief 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.

Detailed 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

Study Timeline

• Status Verified: 2019-04
• Study First Submitted: 2019-04-01
• Study First Submitted QC: 2019-04-12
• Last Update Submitted: 2019-04-12
• Study First Posted: 2019-04-16
• Last Update Posted: 2019-04-16
• Study Start: 2019-05-02
• Primary Completion: 2023-09-30
• Study Completion: 2023-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 320

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Risk factors for asthma 6 years after an episode of acute bronchiolitis	at 6 years	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.

Secondary Outcome Measures

Name	Time	Method
Correlation between onset of asthma and severity of bronchiolitis	at 6 years	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
relationship between sRAGE serum markers and the occurrence of longer-term asthma	at 6 years	Correlation between onset of asthma and concentration of sRAGE during bronchiolitis
relationship between KL-6 serum markers and the occurrence of longer-term asthma	at 6 years	Correlation between onset of asthma and concentration of KL-6 during bronchiolitis
relationship between CC16 serum markers and the occurrence of longer-term asthma	at 6 years	Correlation between onset of asthma and concentration of CC16 during bronchiolitis.

Trial Locations

Locations (1)

Chu Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France