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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01239199
First received: October 21, 2010
Last updated: February 26, 2014
Last verified: February 2014

October 21, 2010
February 26, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01239199 on ClinicalTrials.gov Archive Site
Atopic status with total and specific IgE levels and skin test, complete blood count [ Time Frame: 1 day ] [ Designated as safety issue: No ]
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?

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.

This study is a epidemiological observation study

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Asthma
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
86
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
Both
6 Months to 36 Months
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01239199
P 070802
No
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