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

Asthma Clinical Trial

— NOnourisson  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01239199
• Other study ID #: P 070802
• Status: Completed
• Phase: N/A
• First received: October 21, 2010
• Last updated: February 26, 2014
• Start date: January 2010
• Est. completion date: May 2011

Study information

• Verified date: February 2014
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

This study is a epidemiological observation study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 36 Months

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• Measure of the exhaled NO
The exhaled NO will be measure by chemiluminescence in current ventilation by an indirect method (off-line)

Locations

Country	Name	City	State
France	Service of multidisciplinary paediatrics (Armand-Trousseau Hospital)	Paris	Ile de France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (76)

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* Note: There are 76 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of exhaled nitric oxide at the beginning of the study and incidence of asthma symptoms after 3 years of follow up		1 day	No
Secondary	Atopic status with total and specific IgE levels and skin test, complete blood count		1 day	No