Nebulized Hypertonic Saline (3%) Versus Nebulized Adrenaline for Treatment of Bronchiolitis: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Duration of hospital stay
研究概览
简要总结
The primary objective of this study was to compare the effectiveness of nebulized hypertonic saline (3%) and nebulized adrenaline in bronchiolitis. The secondary objective was to assess whether non-responders to initial therapy benefit from continuation of the same therapy.
This trial was conducted at a tertiary care teaching hospital over a period of one year in children with bronchiolitis presenting to the out-patient department and emergency. After obtaining a signed informed consent from the parents, all eligible children were assessed for baseline characteristics. A complete hemogram, chest X-ray were done in all and arterial blood gas analysis where ever required.
Computer generated random numbers were used for enrolment in consecutive manner and patients were randomly assigned into two groups. The first group received one dose (4ml) of nebulized hypertonic saline (3%).The second group received one dose (0.1 mg/kg) of nebulized adrenaline diluted in normal saline to make it a 4ml solution. Supportive care (nasal clearing, antipyretics, oxygenation, intravenous fluids) was done in both groups as necessary.
All children were reassessed 20 minutes after one dose of nebulization using the clinical score and a child was labelled as a "responder" if he showed an improvement in the clinical severity score by atleast 3 points after 20 minutes of nebulization. Both responders and non-responders were given a repeat dose of nebulization according to the group to which the child had been randomized, if: a) Severe audible wheeze with severe respiratory distress (severity score ≥9) b) Inability to maintain saturation >92% even on an O2 flow of 4 L/min. Non responders were given a maximum of three continuous doses of nebulization.
Child was considered fit for discharge if he/she was feeding well orally, there was no need for intravenous fluids, clinical severity score ≤3 and maintaining oxygen saturation >92% on room air for a period of more than 12 hours.
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 (Participant)
入排标准
- 年龄范围
- 1 Month 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 1 month to 2 years with moderate to severe bronchiolitis as per Wang score
排除标准
- •Comorbidities such as congenital heart disease, bronchopulmonary dysplasia, cystic fibrosis, neurological diseases
- •Known or suspected immunodeficiency
- •Congenital malformations
- •History of use of steroids within one week prior to presentation
- •Severe disease requiring admission to intensive care unit/mechanical ventilation
研究组 & 干预措施
Group 2 (Adr)
Nebulized with 0.1 mg/kg of adrenaline (non-racemic solution, 1:1000 concentration), which was diluted in normal saline to make it a 4 ml solution, for a duration of 20 minutes
干预措施: Adrenaline (Drug)
Group 1 (HS)
Nebulized with 4 ml of 3% hypertonic saline for a duration of 20 minutes
干预措施: Hypertonic saline (Drug)
结局指标
主要结局
Duration of hospital stay
时间窗: During hospitalization, approximately 2 days
Duration from the time of enrolment to the point at which the discharge criteria (feeding well orally, no need for intravenous fluids, clinical severity score ≤ 3 and maintaining oxygen saturation \>92% on room air for a period of more than 12 hours) are met.
次要结局
- Initial change in the Wang bronchiolitis clinical severity score(20 minutes after the first nebulization)
- Number of hours of intravenous fluid requirement(During hospitalization, approximately 2 days)
- Number of hours of oxygen requirement(Till the time the child maintained a saturation of more than 94% for at least 4 hours)
- Number of doses of nebulization needed(During hospitalization, approximately 2 days)
- Response after each nebulization(Assessed 20 minutes after each nebulization)
研究者
Jerin C Sekhar
Senior Resident, Department of Pediatrics
Maulana Azad Medical College