Chest X-Ray Versus Chest Ultrasound in Diagnosis of Neonatal Pneumonia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Diagnostic accuracy of lung ultrasound versus chest X-ray
研究概览
简要总结
This prospective observational study aims to compare the diagnostic accuracy of chest X-ray versus lung ultrasound in the diagnosis of neonatal pneumonia among neonates admitted to the Neonatal Intensive Care Unit of Assiut University Children's Hospital.
详细描述
Neonatal pneumonia is a leading cause of respiratory morbidity and mortality in the neonatal period. Chest X-ray has traditionally been the reference imaging modality, but it involves ionizing radiation and has moderate sensitivity. Lung ultrasound is a radiation-free, bedside alternative that has shown promising diagnostic performance.
This prospective study will include term and preterm neonates admitted to the NICU with clinical suspicion of pneumonia within the first 28 days of life. All participants will undergo both portable chest X-ray and standardized lung ultrasound performed by trained examiners blinded to each other's findings. Diagnostic accuracy of both modalities will be compared against a composite clinical reference standard.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Minute 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Neonates (term and preterm) admitted to the NICU
- •Clinical diagnosis of pneumonia within the first 28 days of life
- •Written informed consent from parents or legal guardians
排除标准
- •- Major congenital pulmonary or cardiac structural malformations that would confound imaging interpretation
- •Lethal congenital anomalies or chromosomal abnormalities incompatible with survival
研究组 & 干预措施
Single cohort: Neonates with clinical suspicion of pneumonia
Term and preterm neonates admitted to the NICU with clinical signs suggestive of pneumonia who will undergo both chest X-ray and lung ultrasound for diagnostic comparison.
结局指标
主要结局
Diagnostic accuracy of lung ultrasound versus chest X-ray
时间窗: At the time of clinical suspicion of pneumonia (Baseline)
Sensitivity, specificity, positive predictive value, and negative predictive value of lung ultrasound compared with chest X-ray for the diagnosis of neonatal pneumonia, using a composite clinical reference standard.
次要结局
- Comparison of radiographic and sonographic findings(Baseline)
- Correlation with clinical severity(Baseline)
- Risk factors associated with neonatal pneumonia(Baseline)
研究者
Rana Hosny Rayan Manaa
Resident Physician
Assiut University