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

NCT07520149 | Not Yet Recruiting

• 1 other identifier: CXR in Neonatal CHD Detection
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Congenital Heart Disease; Chest X-ray for Clinical Evaluation; Neonates

Keywords

Congenital Heart Disease; Chest X-Ray; Neonates; Echocardiography; Chest Radiography

Outcome Measures

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.

  Up to 96 hours from initial clinical presentation

Study Arms (1)

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.

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• Infants aged more than 28 days.
• Infants with no clinical or radiological evidence of CHD.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at Pediatric Department, Assiut University

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: April 9, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04