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Acute Bronchiolitis in Infants and Allergic Asthma

Primary Purpose

Acute Bronchiolitis, Asthma, Allergy

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Pneumological evaluation
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Bronchiolitis focused on measuring allergic asthma, acute bronchiolitis, allergic sensitization, -risk factor

Eligibility Criteria

7 Years - 9 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chu Clermont-Ferrand

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

group 1

Arm Description

cohorts of infants with acute bronchiolitis

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
relationship between CC16 serum markers and the occurrence of longer-term asthma
Correlation between onset of asthma and concentration of CC16 during bronchiolitis.
relationship between sRAGE serum markers and the occurrence of longer-term asthma
Correlation between onset of asthma and concentration of sRAGE during bronchiolitis

Full Information

First Posted
April 1, 2019
Last Updated
April 12, 2019
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT03915197
Brief Title
Acute Bronchiolitis in Infants and Allergic Asthma
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2, 2019 (Anticipated)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Bronchiolitis, Asthma, Allergy
Keywords
allergic asthma, acute bronchiolitis, allergic sensitization, -risk factor

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
no masking
Allocation
N/A
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group 1
Arm Type
Experimental
Arm Description
cohorts of infants with acute bronchiolitis
Intervention Type
Diagnostic Test
Intervention Name(s)
Pneumological evaluation
Intervention Description
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
Primary Outcome Measure Information:
Title
Risk factors for asthma 6 years after an episode of acute bronchiolitis
Description
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.
Time Frame
at 6 years
Secondary Outcome Measure Information:
Title
Correlation between onset of asthma and severity of bronchiolitis
Description
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
Time Frame
at 6 years
Title
relationship between KL-6 serum markers and the occurrence of longer-term asthma
Description
Correlation between onset of asthma and concentration of KL-6 during bronchiolitis
Time Frame
at 6 years
Title
relationship between CC16 serum markers and the occurrence of longer-term asthma
Description
Correlation between onset of asthma and concentration of CC16 during bronchiolitis.
Time Frame
at 6 years
Title
relationship between sRAGE serum markers and the occurrence of longer-term asthma
Description
Correlation between onset of asthma and concentration of sRAGE during bronchiolitis
Time Frame
at 6 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise LACLAUTRE
Phone
0473754963
Email
promo_interne_drci@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
André LABBE
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise LACLAUTRE
Email
promo_interne_drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
André LABBE

12. IPD Sharing Statement

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Acute Bronchiolitis in Infants and Allergic Asthma

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