Is the Exhaled Nitric Oxide in Infants a Predictive Marker of Asthma ? (NOnourisson)
26 février 2014 mis à jour par: Assistance Publique - Hôpitaux de Paris
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.
Aperçu de l'étude
Description détaillée
This study is a epidemiological observation study
Type d'étude
Interventionnel
Inscription (Réel)
86
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Ile de France
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Paris, Ile de France, France, 75012
- Service of multidisciplinary paediatrics (Armand-Trousseau Hospital)
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
6 mois à 3 ans (Enfant)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Exhaled NO
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The exhaled NO will be measure by chemiluminescence in current ventilation by an indirect method (off-line)
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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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
Délai: 1 day
|
1 day
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Atopic status with total and specific IgE levels and skin test, complete blood count
Délai: 1 day
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1 day
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Jocelyne Just, Trousseau Hospital - APHP
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
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Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 janvier 2010
Achèvement primaire (Réel)
1 mai 2011
Achèvement de l'étude (Réel)
1 mai 2011
Dates d'inscription aux études
Première soumission
21 octobre 2010
Première soumission répondant aux critères de contrôle qualité
10 novembre 2010
Première publication (Estimation)
11 novembre 2010
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
27 février 2014
Dernière mise à jour soumise répondant aux critères de contrôle qualité
26 février 2014
Dernière vérification
1 février 2014
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- P 070802
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Essais cliniques sur Measure of the exhaled NO
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Memorial Sloan Kettering Cancer CenterRésiliéLes familles ou proches parents des patients traités au MSKCC pour des carcinomes épidermoïdes non cutanés du | Voies aérodigestives supérieuresÉtats-Unis
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University Medicine GreifswaldInscription sur invitationSyndrome d'apnée obstructive du sommeil (SAOS)Allemagne
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Puerta de Hierro University HospitalInstituto de Salud Carlos III; Ministerio de Economía y Competitividad, Spain et autres collaborateursInconnueTrouble déficitaire de l'attention avec hyperactivitéEspagne
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Hospices Civils de LyonRecrutementPerte d'auditionFrance
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UCSF Benioff Children's Hospital OaklandNational Heart, Lung, and Blood Institute (NHLBI)ComplétéAnémie, DrépanocytoseÉtats-Unis