Congenital Heart DiseaseNCT07520149
Chest X-Rays for Early Detection of Congenital Heart Disease in Newborns
An observational study of Congenital Heart Disease and Chest X-ray for Clinical Evaluation, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 0 to 28 days
- Conditions the study is for
- Congenital Heart Disease, Chest X-ray for Clinical Evaluation, Neonates
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- May 2026to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 28 days
- All sexes
- Child
Study 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.
Who may be able to join
- 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.
Who cannot join
- Infants aged more than 28 days.
- Infants with no clinical or radiological evidence of CHD.
About this study
Official title: Evaluation of Chest X-Ray Findings in Early Detection of Congenital Heart Disease in Neonates
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.
Read more
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.
Read the detailed description
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.
- Keywords
- Congenital Heart Disease, Chest X-Ray, Neonates, Echocardiography, Chest Radiography
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 96 hours from initial clinical presentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study startMay 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerolos Samir Seed Gerges, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07520149
- Sponsor's protocol ID
- CXR in Neonatal CHD Detection
- Status last verified
- Apr 2026
- First submitted
- 3 Apr 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Chest X-Ray Findings in Early Detection of Congenital Heart Disease in Neonates
- ClinicalTrials.gov ID
- NCT07520149
- Acronym / sponsor ID
- CXR in Neonatal CHD Detection
- Keywords
- Congenital Heart Disease, Chest X-Ray, Neonates, Echocardiography, Chest Radiography
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Age groups
- Child
- Study 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Infants aged more than 28 days.
- Infants with no clinical or radiological evidence of CHD.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity of Chest X-Ray for Detecting Congenital Heart Disease
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease and Chest X-ray for Clinical Evaluation, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of Chest X-Ray for Detecting Congenital Heart Disease (time frame: Up to 96 hours from initial clinical presentation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.