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

Sponsor
Assiut University
Study ID
NCT07520149
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
0 Days - 28 Days
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Apr 9, 2026
Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
May 31, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Sensitivity of Chest X-Ray for Detecting Congenital Heart Disease [ Time Frame: Up to 96 hours from initial clinical presentation ]

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