Feasibility and Acceptability Followed by Effectiveness of Bubble Continuous Positive Airway Pressure (bCPAP) for Treatment of Children Aged 1-59 Months With Severe Pneumonia in Ethiopia: A Cluster Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,240
- 试验地点
- 2
- 主要终点
- For stage I and II feasibility and acceptability of bubble CPAP in two tertiary and two district hospitals will be measured in number and reported in percentage
研究概览
简要总结
Principal Investigator: Mohammod Jobayer Chisti
Research Protocol Title: Feasibility and Acceptability Followed by Effectiveness of Bubble Continuous Positive Airway Pressure (bCPAP) for Treatment of Children aged 1-59 months with Severe Pneumonia in Ethiopia: A Cluster Randomized Controlled Clinical Trial
Proposed start date: 1st July 2018, Estimated end date: 31st December 2022
Background: Feasibility and acceptability followed by effectiveness of bubble continuous positive airway pressure (CPAP) were not evaluated in childhood severe pneumonia in developing countries at a larger scale.
Objectives:
Stages I and II
- To assess the feasibility and acceptability (not only by patients' care-givers but also by physicians and nurses) of bubble CPAP in treating childhood severe pneumonia in two tertiary hospitals in Stage I and in two district hospitals in Stage II
- To record adverse events following use of bubble CPAP in these settings
- To understand how much resource and time are needed to institutionalize and maintain bubble CPAP as a routine practice in the health system
Stage III:
- To determine therapeutic efficacy/effectiveness of bubble CPAP compared to WHO standard low flow oxygen in reducing treatment failure in children admitted to hospitals with severe pneumonia and hypoxemia
- To determine therapeutic effectiveness of bubble CPAP compared to WHO standard low flow oxygen in reducing treatment failure & mortality in children aged 1-12 months admitted to hospitals with severe pneumonia and hypoxemia
- To record adverse events (pneumothorax, abdominal distension, nasal trauma, aspiration pneumonia) encountered.
详细描述
Methodology:
Cluster randomized controlled clinical trial
Methodology:
- Stages I and II: Feasibility/demonstration stage will be done as an internal pilot in 3 hospitals
a. Current treatment practice, facilities, and operational challenges will be evaluated for the introduction, clinical use and maintenance of bubble CPAP 2. Stage III: Implementation of bubble CPAP will be done in 12 hospitals a. It will be done following a cluster randomized design
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
As it was an open-labeled randomized controlled clinical trial, there was no masking in any intervention.
入排标准
- 年龄范围
- 1 Month 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 1 month and 59 months,
- •Meet WHO clinical criteria for severe pneumonia with hypoxemia.
- •Oxygen saturation <90% despite standard flow oxygen therapy
- •Parent/guardian gives informed consent to participate in the study
排除标准
- •Known congenital heart disease, asthma, or upper -airway obstruction
- •Tracheostomy
- •Pneumothorax
- •Needs mechanical ventilation for any specific reason as decided by the clinician
结局指标
主要结局
For stage I and II feasibility and acceptability of bubble CPAP in two tertiary and two district hospitals will be measured in number and reported in percentage
时间窗: 7 months
Patient level and health professional level challenge is the outcome of phase I and II. All will be measured in number and reported in percentage. For stage I and II: Primary outcome: operational challenges that may include availability of pulse oxymetry, IV cannula, IV antibiotics, oxygen supply system and nasal catheters for treating severe pneumonia Secondary outcomes: prevalence of severe pneumonia associated hypoxemia, their treatment practices, adverse events, mortality and treatment failure
For stage III: Primary outcome: Treatment failure
时间窗: 12-18 months (Mid April 2021 to Mid October 2022)
According to this protocol treatment failure will be declared if the following criteria are met: A. Presence of severe hypoxemia (SpO2\<85%) at any time after at least one hour of intervention plus severe respiratory distress when the child is receiving BCPAP/LF OR, B. If the patient developed the indication of mechanical ventilation when the child is receiving BCPAP/LF OR, C. If the patient died during hospitalization OR, D. If the patient left against medical advice (LAMA) due to lack of improvement or deterioration of the child during hospitalization All will be measured in number and reported in percentage.
次要结局
- Secondary outcomes: • Death • Adverse events (pneumothorax, abdominal distension, nasal trauma, aspiration pneumonia ) encountered(12-18 months (Mid April 2021 to Mid October 2022))