Is the Exhaled Nitric Oxide in Infants a Predictive Marker of Asthma ?
NCT ID: NCT01239199
Last Updated: 2014-02-27
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
86 participants
Study Classification
INTERVENTIONAL
Study Start Date
2010-01-31
Study Completion Date
2011-05-31
Brief Summary
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Background:
It seems that in the infants and the young children, the increase of the Exhaled Nitric Oxide (eNO) is in connection with: (1) the risk of developing respiratory symptoms; (2) the risk of family and personal atopy; (3) the intensity of the respiratory symptoms; (4) the risk of passage of recurrent wheezing to asthma; (5) and contrary to the fact that the investigators noticed at the child's a positive relation with the environmental tobacco smoke
Objective: the investigators objective is to bring to light that the rise of the eNO, a non invasive biomarker of the bronchial inflammation, would be a risk factor expected from passage of recurrent wheezing of the infant and the young child (of less than 36 months old) towards the asthma of the child.Methods: Once the diagnosis of recurrent wheezing established, the investigators estimate by questionnaire the severity of the asthma, the personal and familial atopy, the collection of the environmental data. After allergic exploration (skin tests and assay of serum total and specific IgE, complete blood count), the eNO is measured by an off-line tidal breathing method using a chemiluminescence NO analyzer. Annually, a questionnaire will be send to families to appreciate the persistence or the remission of the asthma. After a simple descriptive analysis of the population and a multifactorial descriptive analysis, the investigators shall look for the connections between the rise of the eNO and the various clinical, biological and environmental parameters known to influence the variations of this marker. Then the investigators shall select a set of explanatory variables for a multivariate analysis by a logistic regression step by step.
It seems that in the infants and the young children, the increase of the Exhaled Nitric Oxide (eNO) is in connection with: (1) the risk of developing respiratory symptoms; (2) the risk of family and personal atopy; (3) the intensity of the respiratory symptoms; (4) the risk of passage of recurrent wheezing to asthma; (5) and contrary to the fact that the investigators noticed at the child's a positive relation with the environmental tobacco smoke
Objective: the investigators objective is to bring to light that the rise of the eNO, a non invasive biomarker of the bronchial inflammation, would be a risk factor expected from passage of recurrent wheezing of the infant and the young child (of less than 36 months old) towards the asthma of the child.Methods: Once the diagnosis of recurrent wheezing established, the investigators estimate by questionnaire the severity of the asthma, the personal and familial atopy, the collection of the environmental data. After allergic exploration (skin tests and assay of serum total and specific IgE, complete blood count), the eNO is measured by an off-line tidal breathing method using a chemiluminescence NO analyzer. Annually, a questionnaire will be send to families to appreciate the persistence or the remission of the asthma. After a simple descriptive analysis of the population and a multifactorial descriptive analysis, the investigators shall look for the connections between the rise of the eNO and the various clinical, biological and environmental parameters known to influence the variations of this marker. Then the investigators shall select a set of explanatory variables for a multivariate analysis by a logistic regression step by step.
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Detailed Description
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This study is a epidemiological observation study
Conditions
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Asthma
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
DIAGNOSTIC
Blinding Strategy
NONE
Study Groups
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Exhaled NO
Group Type
EXPERIMENTAL
Measure of the exhaled NO
Intervention Type
OTHER
The exhaled NO will be measure by chemiluminescence in current ventilation by an indirect method (off-line)
Interventions
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Measure of the exhaled NO
The exhaled NO will be measure by chemiluminescence in current ventilation by an indirect method (off-line)
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* Infant between 6 and 36 months
* More than 3 wheezing episodes
* Questionary and biological assessment for recurrent wheeze
* Signature of the consent by 2 parents or by the only one of 2 parents (if this last one is the only present in the inclusion of the child)
* More than 3 wheezing episodes
* Questionary and biological assessment for recurrent wheeze
* Signature of the consent by 2 parents or by the only one of 2 parents (if this last one is the only present in the inclusion of the child)
Exclusion Criteria
* Infant with respiratory disease in neonatal period
* Infant with other obstructive pathology (cystic fibrosis, Primary Ciliary Dyskinesia,…)
* Infant who have a respiratory infection less than 4 weeks
* Infant with asthma exacerbation or who still have corticosteroid treatment
* Infant without social security from their parents
* Infant with other obstructive pathology (cystic fibrosis, Primary Ciliary Dyskinesia,…)
* Infant who have a respiratory infection less than 4 weeks
* Infant with asthma exacerbation or who still have corticosteroid treatment
* Infant without social security from their parents
Minimum Eligible Age
6 Months
Maximum Eligible Age
36 Months
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Jocelyne Just
Role: PRINCIPAL_INVESTIGATOR
Trousseau Hospital - APHP
Locations
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Service of multidisciplinary paediatrics (Armand-Trousseau Hospital)
Paris, Île-de-France Region, France
Site Status
Countries
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France
References
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
P 070802
Identifier Type: -
Identifier Source: org_study_id
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