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

NCT01239199 | Completed

• 1 other identifier: P 070802
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Infants; Exhaled Nitric Oxide; Asthma; Tobacco smoke exposure; environment

Outcome Measures

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

  1 day

Secondary Outcomes (1)

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

  1 day

Study Arms (1)

Exhaled NO

EXPERIMENTAL

Other: Measure of the exhaled NO

Interventions

Measure of the exhaled NO OTHER

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

Exhaled NO

Eligibility Criteria

• Age: 6 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infant between 6 and 36 months
• More than 3 wheezing episodes
• Questionary and biological assessment for recurrent wheeze

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service of multidisciplinary paediatrics (Armand-Trousseau Hospital)

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

Location

Related Publications (76)

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MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Jocelyne Just

  Trousseau Hospital - APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2010
• First Posted: November 11, 2010
• Study Start: January 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: February 27, 2014

Record last verified: 2014-02

Locations

FR (1)