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. Identifier: NCT01239199
Recruitment Status : Completed
First Posted : November 11, 2010
Last Update Posted : February 27, 2014
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

October 21, 2010
November 11, 2010
February 27, 2014
January 2010
May 2011   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01239199 on Archive Site
Atopic status with total and specific IgE levels and skin test, complete blood count [ Time Frame: 1 day ]
Same as current
Not Provided
Not Provided
Is the Exhaled Nitric Oxide in Infants a Predictive Marker of Asthma ?
Is the Exhaled Nitric Oxide in Infants a Predictive Marker of Asthma?


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.

This study is a epidemiological observation study
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Other: Measure of the exhaled NO
The exhaled NO will be measure by chemiluminescence in current ventilation by an indirect method (off-line)
Experimental: Exhaled NO
Intervention: Other: Measure of the exhaled NO

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2011
May 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
6 Months to 36 Months   (Child)
Contact information is only displayed when the study is recruiting subjects
P 070802
Not Provided
Not Provided
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Jocelyne Just Trousseau Hospital - APHP
Assistance Publique - Hôpitaux de Paris
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP