Follow up of Ventilatory Function in Infant After Bronchiolitis During the First Year of Life

This study has been completed.
Sponsor:
Information provided by:
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT00676351
First received: May 12, 2008
Last updated: NA
Last verified: May 2008
History: No changes posted
  Purpose

A significant proportion of asthma is diagnosed during childhood. Bronchiolitis is the most common lower respiratory tract illness (LRI) in early life and the present work is a prospective study undertaken to highlight the possible relationship between LRI in early life and trigger of atopy and asthma in 3 year-old childhood, using paediatric lung function testing.

Twenty nine infants (8 females and 21 males) were included in our study. The beginning of the study started at least three weeks after the first bronchiolitis episode. Pulmonary function test was realized using an infant specific body plethysmography (Babybody, Erich Jaeger, Germany). Same tests were performed at 18 and 24 months. At 30 and 36 months, pulmonary function was evaluated by measuring respiratory resistances using oscillometry and occlusion systems (Masterlab-IOS, Erich Jaeger, Germany). If measured data showed an obstruction, a bronchodilatator was inhaled to assess reversibility. When results were normal, a bronchial provocation test, using inhaled metacholine, was performed.

Skin prick tests (SPTs) were performed during the first exam, and at 24 and 36 months (Stallergenes-DHS).

Collection of data was largely incomplete due to a number of patients lost of follow up. Based on the available data, it can be conclude that most of lung tests results were in the normal range but a non negligible bronchial hyper reactivity was documented (41% of patients).

This study must be continued to increase the number of included patients and to continue their follow up during a longer time.


Condition Intervention
Bronchiolitis
Procedure: body plethysmography

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Follow up of Ventilatory Function in Infant After One (or More) Bronchiolitis During the First Year of Life. Course Towards Asthma

Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • Body plethysmography at least three weeks after the first bronchiolitis episode and at 18 and 24 months [ Time Frame: 18, 24, 30 and 36 months ] [ Designated as safety issue: No ]
  • Respiratory resistances measure (oscillometry and occlusion systems) at 30 and 36 months [ Time Frame: 18, 24, 30 and 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Skin prick tests [ Time Frame: at the first exam, and at 24 and 36 months ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: January 2004
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A
body plethysmography Same tests were performed at 18 and 24 months. At 30 and 36 months, pulmonary function was evaluated by measuring respiratory resistances using an oscillometry system and an occlusion system
Procedure: body plethysmography
Same tests were performed at 18 and 24 months. At 30 and 36 months, pulmonary function was evaluated by measuring respiratory resistances using an oscillometry system and an occlusion system

Detailed Description:

Asthma affects a large population throughout the world and about two millions of persons in France, killing two hundred patients by year. A significant proportion of cases of asthma are diagnosed during childhood. Understanding the relation between early-life infectious exposures and asthma and atopy appears to be considerable interest.

Respiratory infectious illnesses, mostly viral, are very common in childhood. Bronchiolitis is the most common lower respiratory tract illness (LRI) in early life (1). It is commonly caused by respiratory syncytial virus (RSV) and is often associated with subsequent wheezing and childhood asthma (2). Respiratory infectious illnesses caused by other agent than RSV can be also associated with asthma and atopy (3). However, the relation between respiratory infectious illnesses in early life and asthma in childhood is again much debated since some studies show a relationship between bronchiolitis and atopy (4) but not others (5, 6).

The present work is a prospective study undertaken to highlight the possible relationship between LRI in early life and trigger of atopy and asthma in 3 year-old childhood, using paediatric lung function testing.

Twenty nine infants (8 females and 21 males) were included in our study and 8 of 29 infants were of premature birth. The youngest patient was 3 months old and the older fourteen months old. The beginning of the study started at least three weeks after the first bronchiolitis episode. Pulmonary function test was realized using body plethysmography (Babybody, Erich Jaeger, Germany). Same tests were performed at 18 and 24 months. At 30 and 36 months, pulmonary function was evaluated by measuring respiratory resistances using an oscillometry system and an occlusion system (Masterlab-IOS, Erich Jaeger, Germany). All respiratory tests were performed on patients in asymptomatic respiratory condition and at least one month apart from respiratory infection. If measured data showed an obstruction, a bronchodilator was inhaled to assess reversibility. When results were normal, a bronchial provocation test, using inhaled metacholine, was performed.

Skin prick tests (SPTs) were performed at the first exam, and at 24 and 36 months (Stallergenes-DHS). Dermatophagoides pteronyssinus, alternaria, cat dander, cockroach, orchard grass and timothy grass were systematically tested. The SPTs were considered positive when the wheal diameter was over 3 mm and 50% larger than the positive control, and the negative control remained negative (7). The possibility of dermographism was eliminated by a negative reaction of the negative control.

Collection of data was largely incomplete due to a number of patients lost of follow up. Briefly, based on the available data, most of lung tests results were in the normal range although a proportion of patients experienced recurrent wheezing episodes during follow up. Nevertheless a bronchial hyper reactivity to metacholine was documented in 41%. Atopy, as screened by SPTs, was detected in a minority of infants (13.5%). Coexistence of bronchial hyper reactivity and atopy was present in only one patient.

These incomplete results highlight the complex interplay between symptoms, bronchial obstruction, bronchial hyper reactivity and atopy in the subsequent development of asthma in wheezy children. Long term follow up is necessary to assess the prognostic value of these parameters.

  Eligibility

Ages Eligible for Study:   3 Months to 32 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • child under 32 months old
  • child suffering from bronchiolitis episode at least 3 weeks before beginning the study

Exclusion Criteria:

  • child over 32 months old
  • child suffering from bronchiolitis episode since less than 3 weeks
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00676351

Locations
France
CRENESSE Dominique
Nice, France, 06000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: Dominique CRENESSE, PU PH CHU de NICE
  More Information

Publications:
Responsible Party: Cynthia GIRAN, Département de la recherche Clinique et de l'Innovation - CHU de Nice
ClinicalTrials.gov Identifier: NCT00676351     History of Changes
Other Study ID Numbers: 02-PHRC-05
Study First Received: May 12, 2008
Last Updated: May 12, 2008
Health Authority: France: Direction Générale de la Santé
France: French Data Protection Authority
France: Institutional Ethical Committee

Additional relevant MeSH terms:
Bronchiolitis
Bronchial Diseases
Bronchitis
Lung Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on October 22, 2014