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临床试验/NCT00619918
NCT00619918已完成2 期

Nebulized Hypertonic Saline for Treatment of Viral Bronchiolitis

Children's Hospital Los Angeles2 个研究点 分布在 1 个国家目标入组 447 人开始时间: 2008年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
447
试验地点
2
主要终点
Admission Rate

研究概览

简要总结

This study aims to examine the effect of nebulized 3% hypertonic saline in the treatment of viral bronchiolitis. The investigators hypothesize that nebulized 3% saline will decrease rate of hospital admission, decrease clinical severity scores, and decrease length of stay.

详细描述

Bronchiolitis is the most common viral respiratory infection in young children and infants. It is responsible for hundreds of thousands of outpatient visits and hospitalizations every year. Hypertonic saline may decrease swelling in the lung tissue, improve the patient's ability to clear secretions, and decrease nasal congestion. Hypertonic saline nebulizations have already been used effectively in patients with cystic fibrosis and in a few small trials on infants with bronchiolitis. Patients who come to the emergency department or inpatient ward of two urban free-standing pediatric hospitals in California between December and April and are diagnosed with bronchiolitis will be randomized into two groups- the control group will receive nebulized 0.9% normal saline, while the study group will receive nebulized 3% hypertonic saline. Nebulizations will be pretreated with albuterol, to prevent the theoretical risk of increased wheezing in patients with undiagnosed underlying asthma. Patients will be given up to 3 nebulizations in the emergency department, after which time the attending physician will decide whether admission to the hospital is required. Patients who are admitted will continue to receive the same nebulized treatment every 8 hours until discharged. Additional interventions such as epinephrine treatments and antibiotics can be ordered as indicated by the patient care team.

Investigators will measure symptom severity before and after treatments using the respiratory distress assessment instrument (RDAI). The investigators will compare rates of being admitted to the hospital in each group. The investigators will also compare RDAI scores, average length of stay, number of additional respiratory treatments needed, number of hours requiring oxygen, amount of IV fluid needed, and frequency of adverse effects. The investigators hypothesize that nebulized hypertonic saline will be a safe, cost-effective, and efficacious therapy which can be utilized in the outpatient setting to prevent hospital admission, as well as decrease length of stay for patients who require admission. Given the significant disease burden of viral bronchiolitis, the potential impact is substantial.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
— 至 24 Months(Child)
性别
All
接受健康志愿者

入选标准

  • clinical diagnosis of viral bronchiolitis
  • between November and April

排除标准

  • prematurity < 34 weeks
  • chronic lung disease
  • congenital heart disease
  • history of wheezing, asthma or albuterol use
  • tracheostomy status
  • need for intensive care of assisted ventilation

研究组 & 干预措施

Nebulized 3% Saline

Experimental

3% NaCl, 4 mL inhalation, up to 3 inhalations every 20 minutes in the ED, and Q8H in the inpatient setting.

干预措施: Nebulized 3% saline (Drug)

Nebulized 0.9% Saline

Placebo Comparator

0.9% NaCl, 4 mL inhalation, up to 3 inhalations every 20 minutes in the ED, and Q8H in the inpatient setting.

干预措施: Nebulized 0.9% saline (Drug)

结局指标

主要结局

Admission Rate

时间窗: 1 day

Patients enrolled in the ED who required inpatient admission. Patients who required admission but were transferred to another facility due to lack of available beds were considered admitted for this outcome. Note, neither study site has an observation unit.

Length of Stay

时间窗: 1 month

Length of stay defined as date of discharge minus date of admission (whole days)

Change in RDAI Score

时间窗: 1 Hour

The Respiratory Distress Assessment Instrument (RDAI) is a respiratory severity score ranging from a low score of 0 to maximum score of 17. Lower scores indicate more mild symptoms; mild disease (0-6), moderate disease (7-11), and severe (12-17). A decrease in score of 2 is considered clinically significant improvement.

次要结局

  • Hours of Oxygen Use(14 days)
  • IV Fluid Use(14 days)
  • Number of Participants With Supplemental Medication Use(14 days)

研究者

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

Susan Wu

Assistant Professor of Clinical Pediatrics

Children's Hospital Los Angeles

研究点 (2)

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