Acute Bronchiolitis and Severity Markers: Interest in Protein CC16
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Serum CC16 rate
研究概览
简要总结
Acute bronchiolitis is a common viral infection in infants mainly due to RSV and rhinovirus.
Biomarkers can be useful for predicting its severity. The serum CC16 is a marker of epithelial aggression. Its rate increase during RSV bronchiolitis in infants less than 7 months. It could be an early predictive biomarker of the severity of acute bronchiolitis, and secondarily for the development of asthma.
Two other markers of airway aggression seem to increase during acute bronchiolitis: serum SP-D protein and serum soluble receptor sRAGE.
详细描述
Prospective, monocentric, case-control and study Primary end-point: correlation between serum CC16 level and severity of the bronchiolitis, evaluated by a clinical scoring system established at the time of the admission in Paediatric Emergency Unit. Secondary end-points: correlation with urinary CC16; correlation with risk factors for bronchial epithelial aggression, viruses, immediate morbidity and mortality. Study of serum SP-D and sRAGE levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants under 1 year old hospitalized for acute bronchiolitis
排除标准
- •Broncho dysplasia
- •Preterm under 34 weeks
- •Cystic fibrosis
- •Immune deficiency
- •Suspicion of primary ciliary dyskinesia
- •Congenital heart disease
- •Acute renal failure
研究组 & 干预措施
acute bronchiolitis
Prospective, monocentric, case-control and study Primary end-point: correlation between serum CC16 level and severity of the bronchiolitis, evaluated by a clinical scoring system
干预措施: Protein CC16 (Drug)
结局指标
主要结局
Serum CC16 rate
时间窗: at day 1
次要结局
- Urinary CC16 rate(at day 1)
- SP-D rates(at day 1)
- sRAGE rates(at day 1)