Acute Bronchiolitis in Infants and Allergic Asthma

April 12, 2019 updated by: University Hospital, Clermont-Ferrand

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

320

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • CHU Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 9 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at 6 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at 6 years
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
at 6 years
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.
at 6 years
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
at 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 2, 2019

Primary Completion (Anticipated)

September 30, 2023

Study Completion (Anticipated)

October 30, 2023

Study Registration Dates

First Submitted

April 1, 2019

First Submitted That Met QC Criteria

April 12, 2019

First Posted (Actual)

April 16, 2019

Study Record Updates

Last Update Posted (Actual)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 12, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-433
  • 2018-A02659-46 (Other Identifier: 2018-A02659-46)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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