Inhaled Corticosteroids in U-5 Children With Acute Respiratory Infection in Uganda: A Randomised Trial (ICS)

Inhaled Corticosteroids in U-5 Children With Acute Respiratory Infection in Uganda: A Randomised Trial

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

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.

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.

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

The average duration of hospitalisation in the intervention compared to the placebo group. The average duration of hospitalisation in the pneumonia compared to the children with asthma per treatment arm.

Health workers' attitudes and perceptions towards use of inhaled corticosteroids, Mothers/ caretakers' level of satisfaction with the treatment

Proportion of health workers who know how to treat ALRI in children, attitudes and perceptions towards use of inhaled corticosteroids Mothers/ caretakers' level of satisfaction with the treatment given during hospitalisation.

Inclusion Criteria: children aged 2 to 59 months with cough and or difficult breathing Exclusion Criteria: 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

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