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临床试验/NCT02162745
NCT02162745已完成3 期

Randomized Controlled Trial to Evaluate the Efficacy of Nasal Irrigation in Infants With Bronchiolitis

IRCCS Burlo Garofolo2 个研究点 分布在 1 个国家目标入组 133 人开始时间: 2012年10月最近更新:
适应症
干预措施
相关药物

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

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%)

Experimental

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%)

Experimental

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

发起方
IRCCS Burlo Garofolo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ronfani Luca

MD, PhD

IRCCS Burlo Garofolo

研究点 (2)

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