ICS: Inhaled Corticosteroids in U-5 Children With Acute Respiratory Infection in Uganda: A Randomised Trial
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Inhaled fluticasone propionate Inhaled corticosteroid |
Drug: Inhaled corticosteroid
Inhaled fluticasone 500mcg 12 hourly up to discharge or a maximum of 5 days
Other Names:
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| Placebo Comparator: Inhaler propellant Placebo |
Other: Placebo
Placebo to be administered 12hourly
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Makerere University College of Health Sciences | Kampala | Uganda |
Sponsors and Collaborators
- Makerere University
- University of Copenhagen
Investigators
- Principal Investigator: Grace Ndeezi, PhD, Makerere University
- Study Chair: Marianne S Østergaard, PhD, University of Copenhagen
- Study Director: James K Tumwine, PhD, Makerere University
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Nantanda R, Hildenwall H, Peterson S, Kaddu-Mulindwa D, Kalyesubula I, Tumwine JK. Bacterial aetiology and outcome in children with severe pneumonia in Uganda. Ann Trop Paediatr. 2008 Dec;28(4):253-60. doi: 10.1179/146532808X375404.
- Okoromah CN, Oviawe O. Is childhood asthma underdiagnosed and undertreated? Niger Postgrad Med J. 2002 Dec;9(4):221-5.
- Østergaard MS, Nantanda R, Tumwine JK, Aabenhus R. Childhood asthma in low income countries: an invisible killer? Prim Care Respir J. 2012 Jun;21(2):214-9. doi: 10.4104/pcrj.2012.00038.
- Østergaard MS, Prahl P. Diagnosis of preschool asthma: parents' comments and typical phrases may ease history-taking. Prim Care Respir J. 2007 Jun;16(3):194-5.
- Sachdev HP, Mahajan SC, Garg A. Improving antibiotic and bronchodilator prescription in children presenting with difficult breathing: experience from an urban hospital in India. Indian Pediatr. 2001 Aug;38(8):827-38.
- HS1259