A Randomized Trial of Nebulized 3% Hypertonic Saline With Salbutamol in the Treatment of Acute Bronchiolitis in Pediatric Hospital
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Score Respiratory Distress
研究概览
简要总结
- Determine the efficacy of nebulized salbutamol/hypertonic saline combination in moderate to severe bronchiolitis.
详细描述
- Study design: double-blind, randomized, parallel-controlled prospective study.
- Location: Department of pediatric emergencies and pediatric hospitalization of Highly Specialized Medical Unit (HSMU), Hospital of Gynecology-Obstetrics and Paediatrics (HGOP) No. 48, Mexican Institute of Social Security (MISS).
- Patients: 50 patients were included; 25 for each group. Patients had between 2 and 24 months of age with a first episode of wheezing associated with respiratory distress and a history of infection of the upper respiratory tract, with moderate to severe degree of respiratory distress according to the Respiratory Distress Scale of Sant Joan de Déu Hospital (SJDH) .
- Interventions: the randomly allocated patients received in group I nebulised 0.9% saline with salbutamol 100 micrograms / kg / dose for 3 initial sessions lasting 20 minutes each and every 4 hours. In group II , hypertonic (3%) saline plus salbutamol 100 micrograms / kg / dose for 3 initial sessions lasting 20 minutes each and every 4 hours. In both groups, will be performed at baseline Scale SJDH Respiratory Distress and the end of the first 3 sessions, you will have 30 minutes to make the second evaluation and at 4 hours the third at 8 hours and then every 24 hours throughout the hospital stay . The independent variable is the intervention with hypertonic saline 3% and the variable primary outcome will be assessed improvement or cure with Respiratory Distress Scale SJDH and secondary outcome will be the time of hospital stay .
- Descriptive statistics of all variables will be reported. T test was used for two independent groups or nonparametric test according to the distribution of the variables to compare the clinical improvement between the groups with the Scale of Respiratory Distress SJDH, as well as to determine whether there is a difference in time of hospital stay between the two study groups. Square test or Fisher exact chi used to compare readmissions for bronchial hyperresponsiveness between the two groups as well as the complications of the disease itself in each study group. Be reported with frequencies and percentages side effects of hypertonic saline 3%. Was considered statistically significant p <0.05. The results with the Number Cruncher Statistical System (NCSS) 2004 statistical program will be discussed.
- The sample size was calculated with t-test to compare means of continuous variables, resulting in 25 subjects per group.
- In the follow-up period it was possible to obtain more patients from the baseline estimate of the sample number.
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
- 2 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All pediatric patients aged 2 months to 24 months of age, both genders attending the pediatric emergency service.
- •With first episode of wheezing associated with respiratory distress and a history of upper respiratory tract infection.
- •You have the evaluation of respiratory difficulty with Scale Hospital Sant Joan de Deu (HSJD) from 6 to 16 at entry points (moderate and severe degree).
排除标准
- •Subjects with a history of previous wheezing, asthma, or who have received bronchodilator treatment before the present illness.
- •Subjects with chronic lung disease, with heart disease, with congenital or acquired anatomic abnormalities of the airway.
研究组 & 干预措施
Nebulized 0.9% Sodium Chloride
Salbutamol 100 micrograms / kg / dose administered 0.9 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.
干预措施: 0.9% Sodium Chloride (Drug)
Nebulized 3% Sodium Chloride
Salbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.
干预措施: 3% Sodium Chloride (Drug)
结局指标
主要结局
Score Respiratory Distress
时间窗: Basal, 30 minutes after the end of the first 3 continuous nebulization sessions, at 4 hours, 8 hours and every 24 hours during the entire hospital stay
It is a validated clinical scale, sufficiently reliable measure of Severity of the respiratory distress. It consists of the summation score of the sibilance / crackling parameters (the largest of them), respiratory effort, pulmonary air inlet, oxygen saturation, heart rate and breathing rate. It is stratified into 3 levels of severity: mild from 0 to 5 points, moderate from 6 to 10 and severe from 10 to 16.
Hours of Hospital Stay
时间窗: Throughout the stay for each patient until discharge. Follow-up will be continued for a period of 30 days in which they may present readmissions, complications or adverse effects.
Each patient record the time of entry and measured the total hospital stay time in hours, recording the time of discharge to determine the total stay in hours. The hospital stay will be evaluated in hours. Staying hospitalized until they had mild respiratory stage scale scores for at least 2 hrs.
次要结局
- Hospital Readmission(Throughout the stay for each patient until discharge. Follow-up will be continued for a period of 30 days in which they may present readmissions, complications or adverse effects.)
- Frequency of Complications of the Disease Itself(Throughout the stay for each patient until discharge. Follow-up will be continued for a period of 30 days in which they may present readmissions, complications or adverse effects.)