Chest X-Rays for Early Detection of Congenital Heart Disease in Newborns
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-28
SponsorAssiut University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Infants aged more than 28 days.
Infants with no clinical or radiological evidence of CHD.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
60 Participants
are grouped into 1 trial groupGroup A: Neonates with Suspected Congenital Heart Disease
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 96 hours from initial clinical presentationLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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