Evaluation of Chest X-Ray Findings in Early Detection of Congenital Heart Disease in Neonates
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Sensitivity of Chest X-Ray for Detecting Congenital Heart Disease
研究概览
简要总结
Congenital heart disease (CHD) is a common condition affecting newborns that can be serious if not caught early. While echocardiograms are the best way to diagnose CHD, they are not always immediately available. Chest X-rays are widely available and are often the first test used when a newborn has breathing problems, a heart murmur, or a bluish skin tint.
The purpose of this study is to determine how accurate standard chest X-rays are at finding congenital heart disease in newborns.
Researchers will observe 60 newborns (up to 28 days old) admitted to the Neonatal Intensive Care Unit (NICU) who have signs or symptoms that suggest they might have a heart problem. Each baby in the study will receive a standard chest X-ray within 24 hours of their clinical presentation. Within 72 hours, they will also receive an echocardiogram, which is the standard, definitive test used to confirm if there is a heart defect.
By comparing the initial chest X-ray results to the final echocardiogram results, researchers hope to figure out exactly which X-ray patterns are best at predicting specific heart diseases. This could help doctors make faster decisions about treating newborns, potentially reducing delays in diagnosis and improving care.
详细描述
Congenital heart disease (CHD) represents a significant global health burden, and while chest radiography (CXR) is traditionally utilized as an accessible imaging modality, its sensitivity and overall accuracy can vary significantly, particularly for structural anomalies or in preterm neonates. This prospective observational cross-sectional study is designed to systematically evaluate the specific radiographic patterns and limitations of CXR in detecting CHD.
Upon enrollment, each neonate will undergo a comprehensive clinical evaluation by an attending neonatologist or pediatric cardiologist. This assessment includes documenting demographic data, maternal and neonatal history, presenting clinical signs (such as cyanosis type, murmur characteristics, respiratory pattern, and perfusion), and detailed vital signs.
Standardized digital anteroposterior (AP) chest X-rays will be obtained within 24 hours of clinical suspicion. To ensure rigorous and unbiased evaluation, all chest radiographs will be independently interpreted by two experienced pediatric radiologists who are blinded to the clinical and echocardiographic findings. In cases of disagreement, a third senior radiologist will provide a final interpretation. The imaging review will systematically evaluate:
- Cardiac size (defined by a cardiothoracic ratio >0.6) and configuration (e.g., boot-shaped, egg-on-side, snowman configurations).
- Specific chamber enlargement (atrial and ventricular).
- Pulmonary vascularity patterns (normal, plethora, oligemia, or venous congestion).
- Aortic arch sidedness and abnormalities. Within 72 hours of the chest radiograph, transthoracic echocardiography will be performed by a pediatric cardiologist to serve as the gold standard diagnostic reference. Diagnoses will be classified according to the International Pediatric and Congenital Cardiac Code (IPCCC) system into four main categories: acyanotic CHD with left-to-right shunt, acyanotic CHD with obstruction, cyanotic CHD, and complex CHD involving multiple defects.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 0 Days 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates aged 0-28 days admitted to the NICU with X-ray findings suspecting CHD during the study period.
- •Neonates presenting with clinical signs suggestive of congenital heart disease, including: cyanosis (central or peripheral), heart murmur detected on auscultation, tachypnea, or respiratory distress.
- •Neonates with abnormal pulse oximetry findings (oxygen saturation <95% in room air).
- •Neonates with abnormal antenatal ultrasound findings suggesting cardiac anomalies.
排除标准
- •Infants aged more than 28 days.
- •Infants with no clinical or radiological evidence of CHD.
研究组 & 干预措施
Neonates with Suspected Congenital Heart Disease
Neonates aged 0 to 28 days admitted to the Neonatal Intensive Care Unit (NICU) presenting with clinical signs (such as cyanosis, heart murmur, or respiratory distress), abnormal pulse oximetry, abnormal antenatal ultrasound findings, or X-ray findings suggestive of congenital heart disease. Participants in this cohort will undergo standard digital chest radiography within 24 hours of clinical suspicion and a confirmatory transthoracic echocardiography within 72 hours.
结局指标
主要结局
Sensitivity of Chest X-Ray for Detecting Congenital Heart Disease
时间窗: Up to 96 hours from initial clinical presentation
The sensitivity (true positive rate) of standard chest radiographs in correctly identifying the presence of congenital heart disease in neonates, using transthoracic echocardiography as the definitive reference standard.
次要结局
未报告次要终点
研究者
Kerolos Samir Seed Gerges
Resident at Pediatric Department, Assiut University
Assiut University