NCT05239559

Feasibility and Acceptability Followed by Effectiveness of bCPAP for Treatment of Bangladeshi Children With Severe Pneumonia

Feasibility and Acceptability Followed by Effectiveness of Bubble Continuous Positive Airway Pressure for Treatment of Bangladeshi Children With Severe Pneumonia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh · Academic / Other
• Sex: All
• Age: 2 Months – 24 Months
• Healthy volunteers: Not accepted

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

Conditions

• Feasibility

Interventions

Type	Name	Description
DEVICE	Bubble CPAP oxygen delivery device	In Bubble CPAP, pressurized oxygen from an oxygen cylinder is delivered to the nasopharynx of the baby. An underwater tube (expiratory arm) that acts as a blow off valve is interposed between the oxygen source and the baby. Adjusting the height of the water column above the exit of the tube can regulate the pressure in the system and the amount of CPAP delivered to the baby. The constant bubbling of gas through the blow off mechanism delivers the bubbling CPAP effect. Oxygen may be delivered by nasal prongs inserted into the nostril of child. The system has three components: 1. Continuous gas flow into the circuit: The gas flow rate required to generate CPAP is usually 5-10 L/min. 2. A nasal interface connecting the child's airway with the circuit: 3. An expiratory arm with the distal end submerged in water to generate end-expiratory pressure. The source of oxygen will be either an oxygen concentrator or cylinder, central distribution through pipelines.

Timeline

• Start date: 2018-12-01
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2022-02-15
• Last updated: 2022-02-15

Locations

2 sites across 1 country: Bangladesh