Acute Respiratory Infections and Asthma in U-5 Children: Improved Treatment to Reduce Morbidity and Mortality in Uganda, A Randomized Controlled Trial
Overview
- Phase
- Phase 3
- Intervention
- Inhaled corticosteroid
- Conditions
- Bacterial Pneumonia
- Sponsor
- Makerere University
- Enrollment
- 1010
- Locations
- 1
- Primary Endpoint
- case fatality
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Inhaled fluticasone propionate
Inhaled corticosteroid
Intervention: Inhaled corticosteroid
Inhaler propellant
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
case fatality
Time Frame: In-hospital mortality
Proportion of enrolled children who die of severe acute lower respiratory infection in the intervention compared to the placebo
Secondary Outcomes
- Hospital stay(From admission to discharge)