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临床试验/NCT01016249
NCT01016249已完成4 期

Nebulized 5% Hypertonic Saline for Infirmary Treatment of Acute Infant Bronchiolitis: A Randomized Trial

Hamad Medical Corporation1 个研究点 分布在 1 个国家目标入组 187 人开始时间: 2007年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
187
试验地点
1
主要终点
Mean pre-nebulization bronchiolitis severity score for each treatment group at 48 hours

研究概览

简要总结

The investigators reasoned that a hypertonic saline concentration higher than 3% could be safe and more efficacious in the treatment of bronchiolitis, alleviating severe symptoms and preventing the need for hospitalization in some instances.

详细描述

We conducted a double blind, randomized, parallel-group clinical trial to compare the efficacy and safety of hypertonic saline 3% and 5% versus normal saline for the treatment of acute bronchiolitis.

The study was conducted in the short stay unit of the Pediatric Emergency Center of Hamad General Hospital, the only pediatric emergency facility in the State of Qatar. The Center serves an average of 200,000 patients annually and manages 42 beds in the short stay unit. Patients admitted to the unit were assessed at least every 6 hours by a pediatrician to determine readiness for discharge. The length of stay in the unit for bronchiolitis range from 6 to 168 hours.

Infants aged ≤18 months presenting to the unit for the treatment of moderate-severe viral bronchiolitis were eligible for the study. Moderate-severe bronchiolitis required having a prodromal history consistent with viral upper respiratory tract infection followed by wheezing and/or crackles on auscultation and a Wang bronchiolitis severity score of ≥ 4 on presentation.

Patients were excluded from the study if they had one or more of the following characteristics: Born preterm ≤34 weeks gestation, previous history of wheezing, steroid use within 48 hours of presentation, obtundation and progressive respiratory failure requiring ICU admission, history of apnea with in 24 hours before presentation, oxygen saturation ≤ 85% on room air at the time of recruitment, history of a diagnosis of chronic lung disease, congenital heart disease, or immunodeficiency.

The six attending physicians who covered the 18 beds in the respiratory section of the short stay unit were trained in scoring and its practical application on our bronchiolitis patients in the unit before the study began.

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
1 Day 至 18 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Infants aged ≤ 18 months presenting to the unit for the treatment of moderate-severe viral bronchiolitis were eligible for the study.
  • Moderate-severe bronchiolitis required having a prodromal history consistent with viral upper respiratory tract infection followed by wheezing and/or crackles on auscultation and a Wang bronchiolitis severity score of ≥ 4 on presentation.

排除标准

  • Patients were excluded from the study if they had one or more of the following characteristics:
  • Born preterm ≤ 34 weeks gestation,
  • Previous history of wheezing,
  • Steroid use within 48 hours of presentation,
  • Obtundation and progressive respiratory failure requiring ICU admission,
  • History of apnea with in 24 hours before presentation,
  • Oxygen saturation ≤ 85% on room air at the time of recruitment,
  • History of a diagnosis of chronic lung disease,
  • Congenital heart disease, or
  • Immunodeficiency.

研究组 & 干预措施

Treatment 1. 5% Saline + Epinephrine

Active Comparator

Nebulization with 4ml of 5% saline mixed with 1.5 ml of epinephrine every 4 hours thereafter until ready for discharge. Immediately before nebulization, just after, and 2 hours after, the following measurements were collected for each patients: bronchiolitis severity score, oxygen saturation on room air, and heart rate.

干预措施: Treatment 1. (5% Hypertonic saline + Epinephrine) (Drug)

Treatment 3. 3% Saline + Epinephrine

Other

Nebulization with 4ml of 3% saline mixed with 1.5 ml of epinephrine every 4 hours thereafter until ready for discharge. Immediately before nebulization, just after, and 2 hours after, the following measurements were collected for each patients: bronchiolitis severity score, oxygen saturation on room air, and heart rate.

干预措施: Treatment 3. (3% Hypertonic saline + Epinephrine) (Drug)

Treatment 2 . 0.9% Saline + Epinephrine

Other

Nebulization with 4ml of 0.9% saline mixed with 1.5 ml of epinephrine every 4 hours thereafter until ready for discharge. Immediately before nebulization, just after, and 2 hours after, the following measurements were collected for each patients: bronchiolitis severity score, oxygen saturation on room air, and heart rate.

干预措施: Treatment 2. (Normal saline + Epinephrine) (Drug)

结局指标

主要结局

Mean pre-nebulization bronchiolitis severity score for each treatment group at 48 hours

时间窗: 2 years

次要结局

  • The treatments' severity scores at 24 hours and trend over time to 72 hours, 2 hours-post-nebulization severity scores trending over time, as well as safety measures(2 years)

研究者

申办方类型
Industry

研究点 (1)

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