Hypertonic Saline in Acute Bronchiolitis: Randomised Controlled Trial and Economic Evaluation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 9
- 主要终点
- Time to 'fit for discharge'
研究概览
简要总结
Acute bronchiolitis is a common, distressing illness affecting children. A virus infects the lungs, and then the airways become blocked, leading to difficulties with breathing. It is the most common reason why children are admitted to hospital, with 1-3% of all children admitted to hospital during their first winter, creating enormous strains on NHS services. The majority of those admitted with the condition are under six months of age and the associated stress for parents is considerable. After forty years of research the best treatment we have is supportive care and oxygen.
Recent research suggests that salt water, sprayed as a mist so that the children can breathe it in ('nebulised 3% hypertonic saline') might help children with acute bronchiolitis. Scientists think that the salt water changes the mucus which blocks the airways so that it can be cleared more easily. Three small research studies all suggested that a child's time in hospital could be reduced by a quarter by using this treatment. If this was true, it would be good for children, their families and the children's wards trying to cope with the large numbers admitted with bronchiolitis every year.
To decide whether this treatment should be used throughout the NHS, we need to run a randomised controlled trial of hypertonic saline in a large number of children. The trial will tell us if adding saline to usual care reduces distress in both children and parents, as well as whether it reduces the length of time they stay in hospital. We will then know if the treatment is the best thing for children with bronchiolitis and whether it provides the NHS with good value for money.
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
- None
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
- •Previously healthy infants under 1 year of age
- •Admitted to hospital with a clinical diagnosis of acute bronchiolitis, following the UK definition of an infant with an apparent viral respiratory tract infection associated with airways obstruction manifest by hyperinflation, tachypnoea and subcostal recession with widespread crepitations on auscultation
- •Requiring supplemental oxygen therapy on admission
排除标准
- •Wheezy bronchitis or asthma - children with an apparent viral respiratory infection and wheeze with no or occasional crepitations
- •Previous lower respiratory tract infections
- •Risk factors for severe disease [gestation <32 weeks, immunodeficiency, neurological and cardiac conditions, chronic lung disease]
- •Subjects where the carer's English is not fluent and translational services are not available
- •Requiring admission to high dependency or intensive care units at the time of recruitment
研究组 & 干预措施
hypertonic saline and usual care
干预措施: 3% hypertonic saline (Device)
usual care (oxygen therapy)
干预措施: 3% hypertonic saline (Device)
结局指标
主要结局
Time to 'fit for discharge'
时间窗: This was judged to be when the infant was feeding adequately [taking >75% of usual intake] and was in air with a saturation of at least 92% for 6 hours, to reflect clinical practice.
The primary objective was an analysis, to show if the addition of 3% hypertonic saline to usual care results in significant \[25%\] reduction in the duration of hospitalisation of infants admitted with acute bronchiolitis. This outcome was measured at 6 hourly intervals, with the first evaluation at time of randomisation.
次要结局
- Actual time to discharge(This was measured from time to randomisation to the discharge time according to routine clinical guidelines.)
- Readmission(Within 28 days from randomisation)
- health care utilisation(post-discharge and within 28 days from randomisation)
- duration of respiratory symptoms(post discharge and within 28 days from randomisation)
- Infant and parental quality of life using the Infant Toddler Quality of Life (ITQoL) questionnaire(28 days following randomisation.)