- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT01239199
Is the Exhaled Nitric Oxide in Infants a Predictive Marker of Asthma ? (NOnourisson)
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.
Tutkimuksen yleiskatsaus
Yksityiskohtainen kuvaus
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
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Ile de France
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Paris, Ile de France, Ranska, 75012
- Service of multidisciplinary paediatrics (Armand-Trousseau Hospital)
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Diagnostiikka
- Jako: Ei käytössä
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: 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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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
---|---|
Measure of exhaled nitric oxide at the beginning of the study and incidence of asthma symptoms after 3 years of follow up
Aikaikkuna: 1 day
|
1 day
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
---|---|
Atopic status with total and specific IgE levels and skin test, complete blood count
Aikaikkuna: 1 day
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1 day
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Yhteistyökumppanit ja tutkijat
Tutkijat
- Päätutkija: Jocelyne Just, Trousseau Hospital - APHP
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
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Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
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Memorial Sloan Kettering Cancer CenterLopetettuMSKCC:ssä ei-kutaanisten levyepiteelikarsinoomien vuoksi hoidettujen potilaiden perheet tai lähisukulaiset | Ylempi ruoansulatuskanavaYhdysvallat
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Boston University Charles River CampusRekrytointiMielenterveyshäiriöt | Työllisyys | Työllisyys, tuettu | MetakognitioYhdysvallat
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University of SurreyEi vielä rekrytointiaHyvinvointi, psykologinenYhdistynyt kuningaskunta
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Skin Analytics LimitedInnovate UKValmis
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Skin Analytics LimitedValmisTyvisolukarsinooma | Okasolusyöpä | Pahanlaatuinen ihomelanooma T0Yhdysvallat, Italia
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Nigde Omer Halisdemir UniversityValmisUrheilun fysioterapiaTurkki
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Skin Analytics LimitedInnovate UKValmis
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Duke UniversityNational Institute of Mental Health (NIMH); National Institute for Medical... ja muut yhteistyökumppanitRekrytointiSitoutuminen, lääkitys | HIV-1-infektio | MielenterveysongelmaTansania
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Hacettepe UniversityValmisDuchennen lihasdystrofia | Yläraajan toiminta | Hengitystoiminnan testi