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Is the Exhaled Nitric Oxide in Infants a Predictive Marker of Asthma ? (NOnourisson)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01239199
Recruitment Status : Completed
First Posted : November 11, 2010
Last Update Posted : February 27, 2014
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Asthma Other: Measure of the exhaled NO Not Applicable

Detailed Description:
This study is a epidemiological observation study
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Is the Exhaled Nitric Oxide in Infants a Predictive Marker of Asthma?
Study Start Date : January 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Exhaled NO Other: Measure of the exhaled NO
The exhaled NO will be measure by chemiluminescence in current ventilation by an indirect method (off-line)


Outcome Measures
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Primary Outcome Measures :
  1. Measure of exhaled nitric oxide at the beginning of the study and incidence of asthma symptoms after 3 years of follow up [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. Atopic status with total and specific IgE levels and skin test, complete blood count [ Time Frame: 1 day ]

Eligibility Criteria
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Ages Eligible for Study:   6 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

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
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): NCT01239199


Locations
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France
Service of multidisciplinary paediatrics (Armand-Trousseau Hospital)
Paris, Ile de France, France, 75012
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Jocelyne Just Trousseau Hospital - APHP
More Information
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Publications:

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01239199    
Other Study ID Numbers: P 070802
First Posted: November 11, 2010    Key Record Dates
Last Update Posted: February 27, 2014
Last Verified: February 2014
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Infants
Exhaled Nitric Oxide
Asthma
Tobacco smoke exposure
environment
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases