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Acute Bronchiolitis in Infants and Allergic Asthma

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ClinicalTrials.gov Identifier: NCT03915197
Recruitment Status : Not yet recruiting
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Study Description
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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.


Condition or disease Intervention/treatment Phase
Acute Bronchiolitis Asthma Allergy Diagnostic Test: Pneumological evaluation Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: no masking
Primary Purpose: Diagnostic
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
Estimated Study Start Date : May 2, 2019
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : October 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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Arm Intervention/treatment
Experimental: group 1
cohorts of infants with acute bronchiolitis
 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


Outcome Measures
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Primary Outcome Measures :
  1. Risk factors for asthma 6 years after an episode of acute bronchiolitis [ Time Frame: 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 :
  1. Correlation between onset of asthma and severity of bronchiolitis [ Time Frame: 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

  2. relationship between KL-6 serum markers and the occurrence of longer-term asthma [ Time Frame: at 6 years ]
    Correlation between onset of asthma and concentration of KL-6 during bronchiolitis

  3. relationship between CC16 serum markers and the occurrence of longer-term asthma [ Time Frame: at 6 years ]
    Correlation between onset of asthma and concentration of CC16 during bronchiolitis.

  4. relationship between sRAGE serum markers and the occurrence of longer-term asthma [ Time Frame: at 6 years ]
    Correlation between onset of asthma and concentration of sRAGE during bronchiolitis


Eligibility Criteria
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Ages Eligible for Study:   7 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915197


Contacts
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Contact: Lise LACLAUTRE 0473754963 promo_interne_drci@chu-clermontferrand.fr

Locations
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France
Chu Clermont-Ferrand
Clermont-Ferrand, France, 63003
Contact: Lise LACLAUTRE       promo_interne_drci@chu-clermontferrand.fr   
Principal Investigator: André LABBE         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: André LABBE University Hospital, Clermont-Ferrand
More Information
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03915197    
Other Study ID Numbers: CHU-433
2018-A02659-46 ( Other Identifier: 2018-A02659-46 )
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Clermont-Ferrand:
allergic asthma
acute bronchiolitis
allergic sensitization
-risk factor
Additional relevant MeSH terms:
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Bronchiolitis
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
 Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Bronchitis
Respiratory Tract Infections
Infections