Is the Exhaled Nitric Oxide in Infants a Predictive Marker of Asthma ? (NOnourisson)
26 februari 2014 uppdaterad av: 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.
Studieöversikt
Detaljerad beskrivning
This study is a epidemiological observation study
Studietyp
Interventionell
Inskrivning (Faktisk)
86
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Ile de France
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Paris, Ile de France, Frankrike, 75012
- Service of multidisciplinary paediatrics (Armand-Trousseau Hospital)
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
6 månader till 3 år (Barn)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Exhaled NO
|
The exhaled NO will be measure by chemiluminescence in current ventilation by an indirect method (off-line)
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Measure of exhaled nitric oxide at the beginning of the study and incidence of asthma symptoms after 3 years of follow up
Tidsram: 1 day
|
1 day
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Atopic status with total and specific IgE levels and skin test, complete blood count
Tidsram: 1 day
|
1 day
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Jocelyne Just, Trousseau Hospital - APHP
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 januari 2010
Primärt slutförande (Faktisk)
1 maj 2011
Avslutad studie (Faktisk)
1 maj 2011
Studieregistreringsdatum
Först inskickad
21 oktober 2010
Först inskickad som uppfyllde QC-kriterierna
10 november 2010
Första postat (Uppskatta)
11 november 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
27 februari 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
26 februari 2014
Senast verifierad
1 februari 2014
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Andra studie-ID-nummer
- P 070802
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