Not Yet RecruitingNot Applicable

Chest X-Rays for Early Detection of Congenital Heart Disease in Newborns

60 participantsStarted 2026-05

Plain-language 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. 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.

Who can participate

Age range

0 Days – 28 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * Infants aged more than 28 days. * Infants with no clinical or radiological evidence of CHD.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Sensitivity of Chest X-Ray for Detecting Congenital Heart Disease

Timeframe: Up to 96 hours from initial clinical presentation

Trial details

NCT IDNCT07520149

SponsorAssiut University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-05

View on ClinicalTrials.gov More Congenital Heart Disease trials