Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:24 PM
Ignite Modification Date:
2025-12-24 @ 2:24 PM
NCT ID:
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
Study:
NCT05239559
Study Brief:
Protocol Section:
NCT05239559