Chest X-Ray Versus Lung Ultrasound in Neonatal Pneumonia
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-28
SponsorAssiut University
About this trial
This prospective observational study aims to compare the diagnostic accuracy of chest X-ray versus lung ultrasound in the diagnosis of neonatal pneumonia among neonates admitted to the Neonatal Intensive Care Unit of Assiut University Children's Hospital.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
- Neonates (term and preterm) admitted to the NICU
Clinical diagnosis of pneumonia within the first 28 days of life
Written informed consent from parents or legal guardians
Disqualifiers
- Major congenital pulmonary or cardiac structural malformations that would confound imaging interpretation
Lethal congenital anomalies or chromosomal abnormalities incompatible with survival
Trial population
Term and preterm neonates admitted to the Neonatal Intensive Care Unit of Assiut University Children's Hospital with clinical diagnosis of pneumonia within the first 28 days of life.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 1 trial groupGroup A: Single cohort: Neonates with clinical suspicion of pneumonia
Trial outcomes
Primary outcomes
1
Diagnostic accuracy of lung ultrasound versus chest X-ray
Sensitivity, specificity, positive predictive value, and negative predictive value of lung ultrasound compared with chest X-ray for the diagnosis of neonatal pneumonia, using a composite clinical reference standard.
Time frame
At the time of clinical suspicion of pneumonia (Baseline)Secondary outcomes
1
Comparison of radiographic and sonographic findings
Description and comparison of chest X-ray findings (opacities, air bronchograms, pleural effusion) and lung ultrasound findings (subpleural consolidation, dynamic air bronchograms, B-lines, pleural line abnormalities).
Time frame
Baseline2
Correlation with clinical severity
Correlation between chest X-ray grading and lung ultrasound scores with clinical severity indices of neonatal respiratory distress (oxygenation index, FiO2 requirement, respiratory support level).
Time frame
Baseline3
Risk factors associated with neonatal pneumonia
Antenatal, perinatal, and postnatal risk factors associated with the diagnosis of neonatal pneumonia.
Time frame
BaselineLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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