Observational Data Collection for Blood Hemoglobin Algorithm Validation in Pediatrics
NCT07706140
Cardiovascular Abnormalities, Cardiovascular Diseases
Boston, Massachusetts, United States
View Trial DetailsNCT Number: NCT07520149
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.
Trial opening soon.
Get Notified0 day–28 day
All sexes
Observational
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:
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
Assiut University
Other
Evaluation of Chest X-Ray Findings in Early Detection of Congenital Heart Disease in Neonates
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