A Double-Blind, Controlled, Randomized Clinical Trial of Nebulized Hypertonic Saline for Hospitalized Infants With Viral Bronchiolitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 227
- 试验地点
- 1
- 主要终点
- Length of Stay in the Study-LOS--Intention to Treat Analysis
研究概览
简要总结
The purpose of this study is to determine if nebulized hypertonic saline (or extra salty water mist) helps infants less than 12 months old hospitalized with bronchiolitis (or bad chest colds) get better enough to be discharged from the hospital sooner than those infants given nebulized normal saline (or regular salty water mist).
详细描述
Bronchiolitis is a common admitting diagnosis for children less than 1 year of age. Although bronchiolitis has a high prevalence, there is a lack of a unified inpatient treatment plan beyond supportive care of supplemental oxygen and intravenous hydration. There have been many different approaches to the treatment of bronchiolitis, but none have conclusively proven to be beneficial. Several early studies show promise for the use of nebulized hypertonic saline, however the majority of these studies are done outside the United States and with adjunctive therapy. To date, the data suggesting that nebulized hypertonic saline is safe and effective for reducing length of stay in bronchiolitis is strong but not generalizable for the United States. The objective of this study is to conduct the first double-blind, randomized controlled trial in the United States of nebulized hypertonic saline without adjunctive therapy, including infants with bronchiolitis, including those with prior history of wheeze, to assess the effect on length of stay and therefore resource utilization.
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 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients 0-12 months of age admitted to the hospital with a diagnosis of bronchiolitis.
排除标准
- •status asthmaticus
- •chronic cardiopulmonary disease
- •Trisomy 21
- •immunodeficiency or transplant recipient
- •neuromuscular disease
- •admission directly to the intensive care unit
- •previous use of nebulized hypertonic saline less than 12 hours prior to presentation
- •previous enrollment in the study in the 72 hours prior to presentation
研究组 & 干预措施
Nebulized Hypertonic Saline
4mL nebulized 3% sodium chloride every 4 hours until discharge
干预措施: 3% sodium chloride (Drug)
Nebulized Normal Saline
4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
干预措施: 0.9% sodium chloride (Drug)
结局指标
主要结局
Length of Stay in the Study-LOS--Intention to Treat Analysis
时间窗: Time of first study treatment until time of discharge
Length of stay will be defined by the duration between the time of first study treatment to the time a discharge order is placed. Alternatively, if a patient remains inpatient for other, non-bronchiolitis related reasons (i.e. social reasons, etc.) the time a patient could be discharged from the standpoint of bronchiolitis as documented by the attending, will be used.
Length of Stay in the Study-LOS by Per Protocol Analysis
时间窗: Time of first study treatment until time of discharge
Length of stay will be defined by the duration between the time of first study treatment to the time a discharge order is placed. Alternatively, if a patient remains inpatient for other, non-bronchiolitis related reasons (i.e. social reasons, etc.) the time a patient could be discharged from the standpoint of bronchiolitis as documented by the attending, will be used.
次要结局
- Readmission for Bronchiolitis Within 7 Days of Discharge(within 7 days of hospital discharge)
- Clinical Worsening(though hospitalization/time period receiving study treatment, average 2-3 days)
- Total Adverse Events(Time of enrollment in the study through 1 week after hospital discharge)
研究者
Alyssa Silver
Attending Physician, Pediatric Hospitalist, Assistant Professor of Pediatrics
Montefiore Medical Center