Acute Respiratory Infection Diagnostic Aids (ARIDA) for Children Under Five Years When Used in a Controlled Setting in Ethiopia: Study Protocol for Controlled Accuracy Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Accuracy of ARIDA test device in children under 5 years with cough or difficulty breathing in a controlled setting.
研究概览
简要总结
Pneumonia is the leading infectious cause of death among children under 5 years of age globally. Many pneumonia deaths result from late care seeking and inappropriate treatment due to misdiagnosis of symptoms. The United Nations Children's Fund's (UNICEF's) Acute Respiratory Infection Diagnostic Aids (ARIDA) project aims to introduce automated respiratory rate (RR) counting aids for use by frontline health workers in resource limited community settings and health facilities. These RR counting aids aim to offer improved accuracy, effectiveness and acceptability compared to current practices for counting and classifying RR to detect fast breathing pneumonia.
The general aim of the controlled accuracy study is to understand whether the ARIDA test device accurately measures RR in children under 5 years of age with cough and/or difficult breathing. It is a cross-sectional, prospective study in a controlled setting comprising three types of device evaluations:
- The accuracy of the ARIDA test device in measuring RR in young infants 0 to <2months, children 2 to <12 months and 12 to 59 months when compared to a video panel reference standard will be established through the first evaluation.
- The consistency of the ARIDA test device will be established by determining the level of agreement between the measures of RR for two ARIDA test devices when used on the same child at the same time in those aged 2 to <12 months and 12 to 59 months through the second evaluation.
- A third evaluation on a different group of normal-breathing children aged 2 to 59 months will assess RR fluctuation over time due to ARIDA test device attachment.
Evaluations 1 and 2 for accuracy and consistency will also be undertaken with expert clinicians (EC) conducting a manual RR count to further the evidence base around the performance of current standard practice in a controlled setting.
The study is a cross-sectional, prospective study and will be conducted in paediatric in and outpatient departments Saint Paul's Hospital and Millennium Medical Collage in Addis Ababa, Ethiopia.
详细描述
General aim:
To understand whether the ARIDA test device accurately measures respiratory rate (RR) in children under 5 years of age with cough and/or difficult breathing.
Primary objective:
To determine the performance of the ARIDA test device, as defined by accuracy and consistency in children under 5 years with cough or difficulty breathing in a controlled setting.
Secondary objectives:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •If newborn or young infant (<2months):
- •Born before 37 weeks of gestation (pre-term)
- •All age groups:
- •Wearing supportive device at area of chest/belly
- •Skin not intact in chest/belly
- •In addition, a child with the following criteria will be excluded from the respiratory rate fluctuation evaluation:
- •Cough or difficult breathing
- •Fast breathing (see table 2)
- •Additional exclusion criteria for child/young infant in an in-patient facility:
- •Child/young infant being managed by barrier nursing (such as severe burns, child with neutropenia, severe infectious diseases).
- •Child/young infant not eligible for research procedures as advised by the supervising clinician.
结局指标
主要结局
Accuracy of ARIDA test device in children under 5 years with cough or difficulty breathing in a controlled setting.
时间窗: Up to 300 seconds
Mean difference with standard deviation (precision) between ARIDA test device and simultaneous reference standard RR results.
Consistency of ARIDA test device in children under 5 years with cough or difficulty breathing in a controlled setting.
时间窗: Up to 300 seconds
Mean difference with standard deviation of respiratory rate readings obtained by two simultaneous ARIDA test devices.
次要结局
- Respiratory rate fluctuation over time after ARIDA test device attachment in normal breathing children aged 2 to 59 months, in a controlled setting.(300 seconds)
- Consistency of expert clinician using standard practice (manual acute respiratory infection timer) in children under 5 years with cough or difficulty breathing in a controlled setting.(60 seconds)
- Accuracy of expert clinician using standard practice (manual ARI timer) in children under 5 years with cough or difficulty breathing in a controlled setting.(60 seconds)