Is the Exhaled Nitric Oxide in Infants a Predictive Marker of Asthma ? (NOnourisson)
2014年2月26日 更新者：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.
調査の概要
詳細な説明
This study is a epidemiological observation study
研究の種類
介入
入学 (実際)
86
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Ile de France
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Paris、Ile de France、フランス、75012
- Service of multidisciplinary paediatrics (Armand-Trousseau Hospital)
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
6ヶ月～3年 (子)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Exhaled NO
|
The exhaled NO will be measure by chemiluminescence in current ventilation by an indirect method (off-line)
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Measure of exhaled nitric oxide at the beginning of the study and incidence of asthma symptoms after 3 years of follow up
時間枠：1 day
|
1 day
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Atopic status with total and specific IgE levels and skin test, complete blood count
時間枠：1 day
|
1 day
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Jocelyne Just、Trousseau Hospital - APHP
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2010年1月1日
一次修了 (実際)
2011年5月1日
研究の完了 (実際)
2011年5月1日
試験登録日
最初に提出
2010年10月21日
QC基準を満たした最初の提出物
2010年11月10日
最初の投稿 (見積もり)
2010年11月11日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年2月27日
QC基準を満たした最後の更新が送信されました
2014年2月26日
最終確認日
2014年2月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Measure of the exhaled NOの臨床試験
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Hürriyet YılmazMedipol University完了
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Massachusetts General HospitalPatient-Centered Outcomes Research Institute; Dartmouth-Hitchcock Medical Center; Griffin Hospital と他の協力者募集
-
Cairo UniversityMohamed, Ahmed A., M.D.; Mohamed Yousry Mohamed; Tamer Fayez Safan; Tamer Mohamed Khair; Islam Mohamed...完了