Feasibility and Acceptability Followed by Effectiveness of bCPAP for Treatment of Bangladeshi Children With Severe Pneumonia
- Conditions
- Feasibility
- Registration Number
- NCT05239559
- Brief Summary
Background: Feasibility and acceptability of bubble continuous positive airway pressure (CPAP) were not evaluated in childhood severe pneumonia in developing countries at a larger scale.
Objective:
1. To describe prevailing structural and functional conditions and other operational challenges in nontertiary hospitals in Bangladesh that would need to be addressed in order to introduce bubble CPAP as part of the management of children with severe pneumonia enabling a successful interventional trial.
2. To develop and test bubble CPAP training materials of relevance to clinical staff providing care for children with severe pneumonia in district general hospitals.
3. To determine the prevalence of hypoxaemia among hospitalised children with severe pneumonia in non-tertiary/district hospitals, current practices with regard to management and clinical outcome, to support power calculations of a future interventional trial of bubble CPAP for children with severe pneumonia.
4. To document the early experience, particularly the feasibility and acceptability of introducing bubble CPAP in selected non-tertiary/district hospitals.
Methodology:
Feasibility/demonstration phase will be done as an internal pilot in 2 hospitals. Current treatment practice, facilities, and operational challenges will be evaluated for the introduction, clinical use and maintenance of bubble CPAP.
Outcome:
1. To describe the structural and functional conditions and operational challenges that may influence the introduction of bubble CPAP.
2. To have bubble CPAP training materials that can be delivered cheaply and repeatedly to a level of comprehension of staff providing care to children with pneumonia in district general hospitals in Bangladesh.
3. A quantitative analysis of the incidence of hypoxaemia among hospitalised children with severe pneumonia, current management practices and clinical outcomes.
4. A qualitative assessment of the feasibility of introducing bubble CPAP.
Number of children to be enrolled: 20 children in 2 hospitals as an internal pilot (i.e. 10 in each hospital)
Main inclusion criteria: Age between 2 months and 24 months with severe pneumonia and hypoxemia and guardian/parent gives written informed consent to participate in the study.
Statistical Analysis: For feasibility and acceptability study, a descriptive analysis will be performed.
Study duration: 44 months
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method A quantitative analysis of the incidence of hypoxaemia among hospitalised children with severe pneumonia, current management practices and clinical outcomes 44 month Prevalence, management, mortality, referral, discharge, hospital stay, oxygen therapy duration of severe pneumonia cases will be identified.
Feasibility and acceptability of introducing bubble CPAP 44 month Challenges related to the introduction of bCPAP, enrollment, patient management with follow-up recording, human resources, respiratory support will be identified.
The structural, functional and operational challenges will be described 44 month Human resources, Supply chain, logistics equipment maintenance, power failure, disconnection of oxygen with local complications will be identified.
To have bubble CPAP training materials that can be delivered cheaply and repeatedly to a level of comprehension of staff providing care to children with pneumonia in district general hospitals in Bangladesh 44 month The training module, Standard Operating Procedure, treatment algorithm will be provided to the hospital staff. Hands-on training will be done.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Institute of Child and Mother Health
🇧🇩Dhaka, Bangladesh
250 bedded General hospital
🇧🇩Kustia, Bangladesh
Institute of Child and Mother Health🇧🇩Dhaka, Bangladesh