Is the Exhaled Nitric Oxide in Infants a Predictive Marker of Asthma ? (NOnourisson)
26 februari 2014 bijgewerkt door: 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.
Studie Overzicht
Gedetailleerde beschrijving
This study is a epidemiological observation study
Studietype
Ingrijpend
Inschrijving (Werkelijk)
86
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Ile de France
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Paris, Ile de France, Frankrijk, 75012
- Service of multidisciplinary paediatrics (Armand-Trousseau Hospital)
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
6 maanden tot 3 jaar (Kind)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Diagnostisch
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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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
Tijdsspanne: 1 day
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1 day
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Atopic status with total and specific IgE levels and skin test, complete blood count
Tijdsspanne: 1 day
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1 day
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Jocelyne Just, Trousseau Hospital - APHP
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
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Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 januari 2010
Primaire voltooiing (Werkelijk)
1 mei 2011
Studie voltooiing (Werkelijk)
1 mei 2011
Studieregistratiedata
Eerst ingediend
21 oktober 2010
Eerst ingediend dat voldeed aan de QC-criteria
10 november 2010
Eerst geplaatst (Schatting)
11 november 2010
Updates van studierecords
Laatste update geplaatst (Schatting)
27 februari 2014
Laatste update ingediend die voldeed aan QC-criteria
26 februari 2014
Laatst geverifieerd
1 februari 2014
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- P 070802
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