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临床试验/NCT05239559
NCT05239559已完成不适用

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

International Centre for Diarrhoeal Disease Research, Bangladesh2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
A quantitative analysis of the incidence of hypoxaemia among hospitalised children with severe pneumonia, current management practices and clinical outcomes

研究概览

简要总结

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

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
2 Months 至 24 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

A quantitative analysis of the incidence of hypoxaemia among hospitalised children with severe pneumonia, current management practices and clinical outcomes

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 44 month

The training module, Standard Operating Procedure, treatment algorithm will be provided to the hospital staff. Hands-on training will be done.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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