Inhaled Corticosteroids in U-5 Children With Acute Respiratory Infection in Uganda: A Randomised Trial (ICS)
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.
Drug: Inhaled corticosteroid
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Supportive Care
|Official Title:||Acute Respiratory Infections and Asthma in U-5 Children: Improved Treatment to Reduce Morbidity and Mortality in Uganda, A Randomized Controlled Trial|
- case fatality [ Time Frame: one year ] [ Designated as safety issue: Yes ]Proportion of children with severe acute lower respiratory infection who die during the study period
- Hospital stay [ Time Frame: From admission to discharge ] [ Designated as safety issue: No ]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 [ Time Frame: study period ] [ Designated as safety issue: No ]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.
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||March 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Inhaled fluticasone propionate
Drug: Inhaled corticosteroid
Inhaled fluticasone 500mcg 12 hourly up to discharge or a maximum of 5 days
Other Name: Inhaled fluticasone propionate
Placebo Comparator: Inhaler propellant
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01868113
|Contact: Grace Ndeezi, PhDfirstname.lastname@example.org|
|Contact: James K Tumwine, PhDemail@example.com|
|Makerere University College of Health Sciences||Recruiting|
|Contact: Grace Ndeezi, PhD +256772453191 firstname.lastname@example.org|
|Contact: James K Tumwine, PhD +256772494120 email@example.com|
|Principal Investigator: Grace Ndeezi, PhD|
|Sub-Investigator: James K Tumwine, PhD|
|Sub-Investigator: Marianne S Østergaard, PhD|
|Principal Investigator:||Grace Ndeezi, PhD||Makerere University|
|Study Chair:||Marianne S Østergaard, PhD||University of Copenhagen|
|Study Director:||James K Tumwine, PhD||Makerere University|