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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of Chest X-Ray for Detecting Congenital Heart Disease | 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. | Up to 96 hours from initial clinical presentation |
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Inclusion Criteria:
Exclusion Criteria:
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The study population consists of neonates aged 0 to 28 days who are admitted to the Neonatal Intensive Care Unit (NICU) at Assiut University Hospital. Eligible participants include those presenting with clinical suspicion of congenital heart disease based on signs such as cyanosis, heart murmurs, or respiratory distress, as well as those with abnormal pulse oximetry findings or abnormal antenatal ultrasound results indicating possible cardiac anomalies.
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |