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Completed

NCT Number: NCT01239199

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.

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Key information

Age range

6 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service of multidisciplinary paediatrics (Armand-Trousseau Hospital)

Paris, Île-de-France Region, 75012, France

About this study

This study is a epidemiological observation study

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Measure of the exhaled NO

Other

The exhaled NO will be measure by chemiluminescence in current ventilation by an indirect method (off-line)

Primary outcomes

  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 outcomes

  1. Atopic status with total and specific IgE levels and skin test, complete blood count

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: NOnourisson

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 11, 2010
Registry last updated
Feb 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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