Bacterial Pneumonia, Viral Pneumonia, Acute Asthma
Conditions
Keywords
Children U-5, ALRI, Inhaled Corticosteroids
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.
Interventions
Inhaled fluticasone 500mcg 12 hourly up to discharge or a maximum of 5 days
OTHERPlacebo
Placebo to be administered 12hourly
Sponsors
University of Copenhagen
Makerere University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Months to 59 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| case fatality | In-hospital mortality | Proportion of enrolled children who die of severe acute lower respiratory infection in the intervention compared to the placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital stay | From admission to discharge | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Health workers' attitudes and perceptions towards use of inhaled corticosteroids, Mothers/ caretakers' level of satisfaction with the treatment | study period | 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. |
Countries
Uganda
Outcome results
None listed