Is the Exhaled Nitric Oxide in Infants a Predictive Marker of Asthma ? (NOnourisson)
26 febbraio 2014 aggiornato da: 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.
Panoramica dello studio
Descrizione dettagliata
This study is a epidemiological observation study
Tipo di studio
Interventistico
Iscrizione (Effettivo)
86
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Ile de France
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Paris, Ile de France, Francia, 75012
- Service of multidisciplinary paediatrics (Armand-Trousseau Hospital)
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 6 mesi a 3 anni (Bambino)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Diagnostico
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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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
Lasso di tempo: 1 day
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1 day
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Atopic status with total and specific IgE levels and skin test, complete blood count
Lasso di tempo: 1 day
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1 day
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Investigatore principale: Jocelyne Just, Trousseau Hospital - APHP
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
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Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 gennaio 2010
Completamento primario (Effettivo)
1 maggio 2011
Completamento dello studio (Effettivo)
1 maggio 2011
Date di iscrizione allo studio
Primo inviato
21 ottobre 2010
Primo inviato che soddisfa i criteri di controllo qualità
10 novembre 2010
Primo Inserito (Stima)
11 novembre 2010
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
27 febbraio 2014
Ultimo aggiornamento inviato che soddisfa i criteri QC
26 febbraio 2014
Ultimo verificato
1 febbraio 2014
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- P 070802
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Prove cliniche su Measure of the exhaled NO
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Memorial Sloan Kettering Cancer CenterTerminatoLe famiglie o i parenti prossimi dei pazienti trattati presso MSKCC per carcinomi a cellule squamose non cutanei del | Tratto aerodigestivo superioreStati Uniti
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Saglik Bilimleri UniversitesiCompletatoIpertensione polmonareTurchia (Türkiye)
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University Medicine GreifswaldIscrizione su invitoSindrome delle apnee ostruttive del sonno (OSAS)Germania
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University of SurreyNon ancora reclutamentoBenessere, PsicologicoRegno Unito
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Dublin City UniversityCompletatoDepressione | Concetto di sé | Composizione del grasso corporeo | Sostegno sociale percepitoIrlanda
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University of FloridaCompletatoCancro ginecologico | Cancro toracico | Cancro gastrointestinale | RegolazioneStati Uniti
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Puerta de Hierro University HospitalInstituto de Salud Carlos III; Ministerio de Economía y Competitividad, Spain; Gammera...SconosciutoDisturbo da deficit di attenzione con iperattivitàSpagna
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Kayseri City HospitalNon ancora reclutamentoEsercizi di aerobica | Linfedema primarioTacchino
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Cuiling FengLinfen Central Hospital; Zhuhai Hospital of Integrated Traditional Chinese and... e altri collaboratoriNon ancora reclutamento