Randomized Controlled Trial to Evaluate the Efficacy of Nasal Irrigation in Infants With Bronchiolitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 133
- 试验地点
- 2
- 主要终点
- Oxygen saturation (%)
研究概览
简要总结
Bronchiolitis is a leading cause of acute illness and hospitalization in the first year of life. Most children with bronchiolitis have mild disease and are managed at home with support from primary care providers, while children with more severe symptoms require supportive therapy with oxygen and fluid administration.
Neonates may be obligate nasal breathers until they are at least 2 months old and nasal obstruction may play a relevant role in respiratory resistances throughout the first months of life, whereas nasal passages may exhibit as much as 50% of the total airway resistance. Some guidelines recommend to clear the nostrils of secretions to improve airway patency but no controlled trial on the efficacy of nasal irrigation in infants with bronchiolitis was carried out.
The aim of this randomized controlled trial is to compare normal saline and hypertonic solution for nasal irrigation versus simple supportive care in infants admitted to Emergency Department with bronchiolitis and mild desaturation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 365 Days(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •infants <1 year
- •diagnosis of bronchiolitis with respiratory distress, rhinitis, cough
- •oxygen saturation between 88 and 94%
排除标准
- •previous treatments (nasal irrigation or suctioning, oxygen, nebulized drugs, nebulized hypertonic solution, antipyretics up to 6 hours before the study entry, oral steroids at any time before study entry)
- •chronic illness
研究组 & 干预措施
Isotonic solution (NaCl 0.9%)
Single nasal irrigation with 1 ml of isotonic solution (NaCl 0.9%) per each nostril
干预措施: Isotonic solution (NaCl 0.9%) (Drug)
Hypertonic solution (NaCl 3%)
Single nasal irrigation with 1 ml of hypertonic solution (NaCl 3%) per each nostril
干预措施: Hypertonic solution (NaCl 3%) (Drug)
结局指标
主要结局
Oxygen saturation (%)
时间窗: up to 50 minutes after allocation
Measurement of arterial oxygen saturation (SpO2) of hemoglobin with digital pulse oximeter
次要结局
- Respiratory effort (WARME score)(5, 15, 20, 50 minutes after allocation)
研究者
Ronfani Luca
MD, PhD
IRCCS Burlo Garofolo
