Utility of Severity Scales in Clinical Practice in Children Hospitalized Due to Bronchiolitis: Prospective Multicentre Cohort Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Number of participants requiring oxygen supplementation
研究概览
简要总结
Prospective observational study of patients hospitalized with bronchiolitis. The objective of our study is to compare the accuracy of commonly used clinical scales for bronchiolitis to predict relevant outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Weeks 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children eligible for the trial must fulfil all of the following criteria:
- •Children admitted to the hospital with the clinical diagnosis of acute bronchiolitis, which is defined as an apparent viral respiratory tract infection associated with airway obstruction manifested by at least one of following symptoms:
- •Tachypnoea (WHO definition).
- •Increased respiratory effort manifested as follows:
- •Nasal flaring;
- •Use of accessory muscles;
- •Intercostal and/or subcostal chest wall retractions;
- •Crackles and/or wheezing.
- •Aged 5 weeks - 24 months old.
排除标准
- •Diagnosis or suspicion of asthma.
结局指标
主要结局
Number of participants requiring oxygen supplementation
时间窗: From admission to hospital discharge up to 2 weeks
Duration of oxygen supplementation
时间窗: From admission to hospital discharge up to 2 weeks
among those requiring oxygen
The time until the infant will be assessed as being 'fit for discharge'
时间窗: From admission to hospital discharge up to 2 weeks
which is defined as the point at which the infant will be feeding adequately (taking \>75% of their usual intake based on parents' assessment) and will have a saturation of at least 92% for 6 h on room air, while the axillary body temperature will remain
Worsening of clinical status, including the following
时间窗: From admission to hospital discharge up to 2 weeks
PICU admission
Adverse events, especially incidence of pneumonia
时间窗: From admission to hospital discharge up to 2 weeks
which is defined as: * temperature increase (fever \>38 ) * deterioration of general condition * inflammatory changes in lung ultrasound or chest X-ray
Hospital length of stay
时间窗: From admission to hospital discharge up to 2 weeks
(\> 3 days)
次要结局
未报告次要终点