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临床试验/NCT01868113
NCT01868113已完成3 期

Acute Respiratory Infections and Asthma in U-5 Children: Improved Treatment to Reduce Morbidity and Mortality in Uganda, A Randomized Controlled Trial

Makerere University1 个研究点 分布在 1 个国家目标入组 1,010 人开始时间: 2012年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
1,010
试验地点
1
主要终点
case fatality

研究概览

简要总结

The purpose of this study is to find out whether adjunct treatment with inhaled corticosteroids lead to faster improvement and reduce mortality of children under 5 years of age admitted to hospital with ALRI.

详细描述

Pneumonia is one of the common causes of serious illness in children under 5 years of age. It is one of the common causes of admission to hospital and the commonest cause of death in Ugandan children under 5 years of age. The signs of pneumonia also occur in children with asthma making it difficult to differentiate the two. Other researchers have found that one of two children under five years of age with pneumonia have asthma. Wheeze which is regarded as a sign of asthma is heard in only one of three children with asthma, implying that many children with asthma especially in the first few years of life are less likely to be diagnosed. They are also less likely to receive inhaled steroids, the recommended treatment for asthma. Failure to administer asthma medicines may contribute to delayed improvement and increase the risk of death. The study hypothesizes that use of inhaled corticosteroids in addition to standard treatment in children hospitalized with ALRI will be associated with reduced morbidity and mortality and that the improvement will be more marked in children diagnosed with asthma posthoc. Outcomes: Reduction in case fatality, Time to normalization of respiratory rate, Time to normalization of oxygen saturation, Duration of hospitalisation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
2 Months 至 59 Months(Child)
性别
All
接受健康志愿者

入选标准

  • children aged 2 to 59 months with cough and or difficult breathing

排除标准

  • Presence of a serious concurrent illness such as meningitis, Children with congenital or acquired heart disease Severe anaemia Measles pneumonia Foreign body inhalation A confirmed diagnosis of pulmonary tuberculosis

研究组 & 干预措施

Inhaled fluticasone propionate

Active Comparator

Inhaled corticosteroid

干预措施: Inhaled corticosteroid (Drug)

Inhaler propellant

Placebo Comparator

Placebo

干预措施: Placebo (Other)

结局指标

主要结局

case fatality

时间窗: In-hospital mortality

Proportion of enrolled children who die of severe acute lower respiratory infection in the intervention compared to the placebo

次要结局

  • Hospital stay(From admission to discharge)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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