Effectiveness of Point-of-care Lung Ultrasound vs Chest X-ray for the Management of Childhood Lower Respiratory Infections in Low-resource Setting: Single Center, Pragmatic, Open-label, Randomized, Controlled, Non-inferiority Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 616
- 试验地点
- 2
- 主要终点
- Correct management plan at the baseline on the basis of clinical assessment and chest image findings
研究概览
简要总结
The goal of this clinical trial is to evaluate the effectiveness of point-of-care lung ultrasound versus chest X-ray for the management of childhood lower respiratory infections in a low-resource setting.
The main question it aims to answer is:
Is point-of-care lung ultrasound as effective as chest X-ray for the management of childhood LRIs in a low-resource setting?
Participants will be assigned to either a point-of-care lung ultrasound group (intervention) or a chest X-ray group (control), to compare the effect on overall case management and various clinical outcomes (time to symptom resolution, rate of antibiotic use, length of stay, treatment costs).
详细描述
Background:
Lower respiratory infections (LRIs) are the leading causes of mortality in children of low-middle income countries (LMICs) including Nepal; pneumonia being the major killer in under-5 population. Often, the cause of mortality is the delay in diagnosis and treatment, particularly when clinical assessments do not hint toward a diagnosis. In resource-limited settings, routine availability of chest X-ray (CXR) service is a challenge, it can be hazardous to children due to exposure to ionizing radiation. The Point-Of-Care Lung UltraSound (POCLUS) could be an alternative solution for the diagnosis and management of LRIs. Studies have already shown that lung ultrasound has a higher sensitivity and specificity than CXR in diagnosing childhood LRIs, however, none of the studies have yet evaluated its role in overall case management.
Methods:
Prospective, single-center, pragmatic, open-label, randomized, controlled, non-inferiority clinical trial, which will be conducted in the outpatient and emergency departments of a pediatric hospital in Nepal. A total of 616 children with clinical suspicion of LRI and requiring chest imaging will be randomized at 1:1 allocation to the intervention (POCLUS) and control (CXR) arms. Pediatricians will be trained to perform lung ultrasonography in children.
Outcomes:
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
入排标准
- 年龄范围
- 2 Months 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with a suspected lower respiratory infection (LRI) brought to the outpatient or emergency department,
- •Requiring chest image for evaluation at baseline.
排除标准
- •Children already hospitalized, received antibiotics, or had chest imaging at the hospital;
- •Follow-up (treated within the past 4 weeks) or referred cases;
- •Critical patients requiring emergency life-saving support including oxygen;
- •Children with one or more danger signs (lethargy or loss of consciousness, convulsion, unable to eat or vomiting everything, cyanosis, excess irritability)
结局指标
主要结局
Correct management plan at the baseline on the basis of clinical assessment and chest image findings
时间窗: From the date of randomization until the final disposition of patient (i.e. discharge, refer), assessed up to 3 weeks. In case of non-hospitalized participants, outcomes evaluated during 2nd follow up (day 7-10 of enrollment), assessed up to 2 weeks.
Proportion of participants who are prescribed a correct management plan at the baseline on the basis of clinical assessment and chest image findings, either point-of-care lung ultrasound or chest X-ray
次要结局
- Time to symptom/sign resolution(From the date of randomization until disposition (i.e. discharge, referral) or symptom resolution criteria is met, whichever is earlier, assessed up to 3 weeks.)
- In-hospital treatment costs(From the date of randomization until disposition (i.e. discharge, referral), assessed up to 3 weeks.)
- Length of stay at hospital(From the date of randomization until disposition (i.e. discharge, referral), assessed up to 3 weeks.)
- Change in diagnosis and management plan(From the date of randomization until Day3-5 of enrollment, assessed up to 1 week.)
- Rate of antibiotic use(From the date of randomization until disposition (i.e. discharge, referral), assessed up to 3 weeks.)
研究者
Suraj BHATTARAI
PhD Fellow
London School of Hygiene and Tropical Medicine