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临床试验/NCT03915197
NCT03915197Unknown不适用

Risk of Allergic Asthma Occurring in the Long Term From an Episode of Acute Bronchiolitis in Infants: Clinical, Allergological and Functional Evaluation in the Long Term

University Hospital, Clermont-Ferrand2 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2019年5月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
320
试验地点
2
主要终点
Risk factors for asthma 6 years after an episode of acute bronchiolitis

研究概览

简要总结

Predicting the risk of allergenic sensitizations and asthma development in the first year of life is difficult.

Investigator decided to follow prospectively two cohorts of infants with acute bronchiolitis, hospitalized or treated at home, from the epidemic seasons of 2011-2012 and 2015-2017 to know their respiratory evolution, especially if they developed allergen sensitization and / or asthma.

详细描述

Follow-up consultation 6 years after an episode of acute bronchiolitis at Clermont-Ferrand hospital with:

  • Consultation with a pneumopediatrician: collection of respiratory symptoms, respiratory treatments, evaluation of the atopic site and environmental risk factors for bronchial aggression, especially passive smoking;
  • Physical examination ;
  • Evaluation of precariousness during the same interview with the EPICES questionnaire;
  • Prick tests with positive control (histamine) and negative (physiological saline) and prick for the main pneumallergens (mites, alternaria, grasses, cat and dog) and trophallergens (egg, milk, fish, soy, wheat, peanut);
  • Blood test with blood count, determination of specific IgE (5 pneumallergens and 5 trophallergens), dosage of sRAGE;
  • Fonctionnal respiratory test with reversibility test

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

盲法说明

no masking

入排标准

年龄范围
7 Years 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Acute bronchiolitis in an infant less than one year old, included in studies KL6 (winter period 2011-2012) or CC16 (winter period 2015-2016) at clermont-ferrand hospital.

排除标准

  • Bronchopulmonary dysplasia;
  • History of prematurity <34 AS;
  • Mucoviscidosis;
  • known immune deficiencies;
  • Primary ciliary dyskinesia suspected;
  • Congenital heart disease;
  • Acute renal failure.
  • Refusal of parents to participate

研究组 & 干预措施

group 1

Experimental

cohorts of infants with acute bronchiolitis

干预措施: Pneumological evaluation (Diagnostic Test)

结局指标

主要结局

Risk factors for asthma 6 years after an episode of acute bronchiolitis

时间窗: at 6 years

Presence / absence of asthma 6-9 years after an episode of bronchiolitis during the first year of life The diagnosis of asthma is established during a consultation by a pneumopediatrician on the following criteria: * ≥3 documented respiratory symptoms ≥ 2 times; * Or an episode lasting ≥ 4 weeks; * With symptoms: tachypnea, wheezing, expiratory stridor, signs of chest retraction or wheezing diagnosed by a doctor.

次要结局

  • Correlation between onset of asthma and severity of bronchiolitis(at 6 years)
  • relationship between sRAGE serum markers and the occurrence of longer-term asthma(at 6 years)
  • relationship between KL-6 serum markers and the occurrence of longer-term asthma(at 6 years)
  • relationship between CC16 serum markers and the occurrence of longer-term asthma(at 6 years)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (2)

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