Acute Bronchiolitis in Infants and Allergic Asthma

NCT03915197 | Unknown

• 2 other identifiers: CHU-4332018-A02659-46
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Bronchiolitis; Asthma; Allergy

Keywords

allergic asthma; acute bronchiolitis; allergic sensitization; -risk factor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Correlation between onset of asthma and severity of bronchiolitis

  at 6 years

• relationship between KL-6 serum markers and the occurrence of longer-term asthma

  at 6 years

• relationship between CC16 serum markers and the occurrence of longer-term asthma

  at 6 years

• relationship between sRAGE serum markers and the occurrence of longer-term asthma

  at 6 years

Study Arms (1)

group 1

EXPERIMENTAL

cohorts of infants with acute bronchiolitis

Diagnostic Test: Pneumological evaluation

Interventions

Pneumological evaluation DIAGNOSTIC_TEST

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

group 1

Eligibility Criteria

• Age: 7 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

Chu Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Asthma; Hypersensitivity

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases

Study Officials

• André LABBE

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise LACLAUTRE

CONTACT

0473754963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: no masking
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 16, 2019
• Study Start: May 2, 2019
• Primary Completion: September 30, 2023
• Study Completion: October 30, 2023
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

FR (1)