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临床试验/NCT02936778
NCT02936778已完成不适用

Risk Factors for Intensive Care Admission of Children With Severe Acute Wheeze or Asthma (SAA)

Erasmus Medical Center1 个研究点 分布在 1 个国家目标入组 221 人开始时间: 2016年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
221
试验地点
1
主要终点
Undertreatment in children admitted to a PICU with a diagnosis of SAA/acute wheeze

研究概览

简要总结

This study will prospectively assess the impact and relevance of several risk factors for children with severe acute asthma (SAA) or acute wheeze that have been identified in retrospective studies. Secondary we will assess short-term medical and psychosocial functioning in patient (and parents) admitted to a PICU for SAA/acute wheeze versus a control group admitted to a MC for SAA/acute wheeze.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
2 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Between 2 and 18 years of age
  • Admission to a PICU for SAA or acute wheeze or admission to a MC for SAA or acute wheeze

排除标准

  • Patient is outside of specified age range
  • Down's Syndrome
  • Congenital/acquired heart defect that interferes with normal SAA treatment
  • Congenital/acquired airway defect (tracheomalacia/bronchomalacia)
  • Primary/secondary immunodeficiency
  • Pre-existing chronic pulmonary condition, known to mimic asthma: Cystic Fibrosis, Bronchopulmonary dysplasia, Bronchiolitis obliterans
  • If both parents are not able to speak the Dutch language

结局指标

主要结局

Undertreatment in children admitted to a PICU with a diagnosis of SAA/acute wheeze

时间窗: Within the time of admission on the PICU/MC, preferably within 48 hours and during follow up after 3-6 months

Undertreatment is defined as: Patient is not using inhaled corticosteroids (ICS), or Patient is using ICS \< 7 days (counting from moment of admission to emergency department) according to treatment plan, or Patient is not using ICS according tot treatment plan.

次要结局

  • Exposure to triggers (single or combined)(Within the time of admission on the PICU/MC, preferably within 24 hours)
  • Severity of disease, defined using the GINA criteria for stepwise management of asthma.(Within the time of admission on the PICU/MC, preferably within 48 hours and during follow up after 3-6 months)
  • Distribution of ADRB2-receptor polymorphisms compared to non-SAA population.(Through study completion, preferably within the time of admission on the PICU/MC)
  • Socio-economic status(Within the time of admission on the PICU/MC)
  • Frequency of previous asthma-related hospital admissions and/or PICU admissions.(Within the time of admission on the PICU/MC and during follow up after 3-6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Matthijs de Hoog

Prof. Dr.

Erasmus Medical Center

研究点 (1)

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