Is the Exhaled Nitric Oxide in Infants a Predictive Marker of Asthma ? (NOnourisson)
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| ClinicalTrials.gov Identifier: NCT01239199 |
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Recruitment Status :
Completed
First Posted : November 11, 2010
Last Update Posted : February 27, 2014
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Asthma | Other: Measure of the exhaled NO | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 86 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| Official Title: | Is the Exhaled Nitric Oxide in Infants a Predictive Marker of Asthma? |
| Study Start Date : | January 2010 |
| Actual Primary Completion Date : | May 2011 |
| Actual Study Completion Date : | May 2011 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Exhaled NO |
Other: Measure of the exhaled NO
The exhaled NO will be measure by chemiluminescence in current ventilation by an indirect method (off-line)
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- 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 ]
- Atopic status with total and specific IgE levels and skin test, complete blood count [ Time Frame: 1 day ]
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| Ages Eligible for Study: | 6 Months to 36 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01239199
| France | |
| Service of multidisciplinary paediatrics (Armand-Trousseau Hospital) | |
| Paris, Ile de France, France, 75012 | |
| Principal Investigator: | Jocelyne Just | Trousseau Hospital - APHP |
Publications:
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT01239199 History of Changes |
| Other Study ID Numbers: |
P 070802 |
| First Posted: | November 11, 2010 Key Record Dates |
| Last Update Posted: | February 27, 2014 |
| Last Verified: | February 2014 |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
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Infants Exhaled Nitric Oxide Asthma Tobacco smoke exposure environment |
Additional relevant MeSH terms:
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Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Nitric Oxide Bronchodilator Agents Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Endothelium-Dependent Relaxing Factors Vasodilator Agents Gasotransmitters Protective Agents |